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Annual Review 2017

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Year’s Top 100 Clinical Developments . . . . . . . . . . . . . . . . . . . . . . 6 Year’s Top 10 Industry News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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TOP 100 NEWS DEVELOPMENTS OF 2017 For more information on news developments listed below, log on to www.LabMedica.com and type appropriate keyword(s) into search engine in order to access full story at news archive

JANUARY Next Generation Qualitative In Vitro MRSA Diagnostic Test Approved n accurate, on-demand, molecular test for methicillin-resistant Staphylococcus aureus (MRSA), which returns results within an hour, has been officially approved for use. The new test is based on a library of MRSA strains from around the world, covering more strains than existing tests. The US Food and Drug Administration

(FDA, Silver Springs, MD, USA; www.fda.gov) has approved a substantial Equivalence Determination for the Xpert MRSA NxG Assay (Cepheid, Sunnyvale, CA, USA; www.cepheid.com) performed on the GeneXpert Instrument Systems.

Calibration Kit Introduced for IVD Testing of Testosterone he first CE-marked calibration kit for more sensitive testosterone measurement in men, women, and children, provides a wide analytical range and increased accuracy at low levels.

Merck (Darmstadt, Germany www.merckgroup. com/en/index.html) announced the introduction of its new testosterone calibrator kit for in vitro diagnostic (IVD) use. The kit allows users to calibrate assays and verify calibrations, and is the first of its kind to receive CE-mark approval, indicating compliance with the European Union’s Medical Device Directive.

New Immunoassay Developed for Zika Virus Detection he new assay can improve patient care by enabling differential diagnostics according to the World Health Organization (WHO) test algorithm. It is capable of detecting Zika virus during the acute phase of infection, approximately a few days after the onset of symptoms. The CE-marked Novagnost Zika virus IgM μ-capture assay, developed by Siemens Healthineers of Siemens Healthcare (Erlangen, Germany, and Tarrytown, NY, USA; www.siemens.com/ healthineers), is now commercially available in many countries (currently not available in the US). The assay is user-friendly, utilizing the same dilution and reagents as other Novagnost assays. It is validated for use on plasma and serum, and can be performed on the BEP III and BEP 2000 Advance Systems.

Rapid Method Determines Free and Total PSA in Serum cientists at the Institute of Nuclear Medicine (Wuxi, Jiangsu, China; www.ujs. edu.cn) developed a novel, sensitive and rapid method to simultaneously determine the free and total prostate-specific antigen (fPSA and tPSA) in serum by combining a time-resolved fluoroimmunoassay (TRFIA) and immunomagnetic separation. The new approach uses magnetic particles as an immobilization matrix and means of separation, whereas the luminescent europium (Eu) and samarium (Sm) chelates are used as probes. The researchers concluded that the simultaneous determination method containing a fast and sensitive approach can be put into an important position to screening large quantities of specimen, and be commonly applied to the clinical determination of fPSA and tPSA in human serum. The study was published on January 19, 2017 in the Journal of Clinical Laboratory Analysis.

Noninvasive Prenatal Testing of Single Gene Diseases Developed cientists at the Chinese University of Hong Kong (Hong Kong SAR, China; www. cuhk.edu.hk) developed a test that can detect almost any single-gene disorder in the first six to 10 weeks of pregnancy. Guided by DNA from parent blood samples, the test looks for increases in the level of mutations associated with a particular condition in the mother’s blood once she is pregnant. In theory, any hospital pathology laboratory could run the test, producing results in one to two weeks. The scientists concluded that high-throughput linked-read sequencing followed by maternal plasma-based relative haplotype dosage analysis rep-

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Year’s Top 100 Clinical Developments resents a streamlined approach for noninvasive prenatal testing of inherited single gene diseases. The study was published in the January 2017 issue of the journal Clinical Chemistry.

Digital CTC Assay Improves Liver Cancer Diagnosis

New Biomarker Reported for Severe Intracerebral Hemorrhage

Early Biomarker Found for Sepsis-Induced Kidney Injury

he association between high serum levels of vascular endothelial growth factor (VEGF) and clinical outcomes of intracerebral hemorrhage (ICH) patients has been investigated by Hebei Medical University (Hebei, China; www.hebmu.org). The results indicated that the optimal cut-off value of VEGF at 72 hours for predicting good outcomes was 111.2 pg/mL with 91.5% sensitivity and 98.7% specificity. The researchers concluded that that the elevated serum levels of VEGF were associated with pathogenesis of ICH and because of which, VEGF could be a new marker in ICH for severity. The study was published on December 20, 2016, in the Journal of Clinical Laboratory Analysis.

cute kidney injury (AKI) is a clinical syndrome of an abrupt renal dysfunction leading to uremic toxins accumulation and several organs dysfunction. An early sepsis-induced acute kidney injury (sepsis-AKI) biomarker is currently needed and urinary neutrophil gelatinase-associated lipocalin (uNGAL) is a candidate of sepsisAKI biomarker. Urinary exosomal activating transcriptional factor 3 (uATF3) has also been mentioned as an interesting biomarker. Researchers at the Chulalongkorn University (Bangkok, Thailand; www.chula.ac.th) concluded that they had identified ATF3, a transcriptional factor; in urine exosome as an interesting sepsis-AKI biomarker. Since

iver cancer, including hepatocellular carcinoma (HCC), is the second highest cause of cancer death in the world. A large team of scientists working with those at Massachusetts General Hospital Cancer Center (Charlestown, MA, USA; www.massgeneral.org) developed a digital PCR assay by first identifying 10 specific ribonucleic acid (RNA) transcripts that were expressed in HCC cells but not in blood components. The test results hold promise for both the early detection of HCC and for the moniVisit us at toring of treatment over time.” The study was published on January 17, 2017 in the Proceedings of the National Academy of Sciences of the United States of America.

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novel smartphone-based optical imaging and molecular assay system permits on-site diagnostics and facilitates transfer of molecular diagnostic data from the point-of-care (POC) to the point-of-expertise, providing a cost-effective means for molecular diagnostics even in resource-limited settings. The device, which can image and analyze specific DNA sequences and genetic mutations in tumor cells and tissue samples without prior DNA extraction, was developed through the collaborative efforts of a group of investigators at the University of California, Los Angeles (USA; www.ucla.edu), Stockholm University (Sweden; www.su.se), and Uppsala University (Sweden; www.uu.se). The device was described in detail in the January 17, 2017 online edition of the journal Nature Communications.

Novel Risk Genes Identified For Bipolar Disorder lthough epidemiological studies indicate that genetic components contribute to bipolar disorder (BD) development, several genome-wide association studies (GWAS) identified limited number of susceptibility (risk) genes for BD, most of which are yet unidentified. A collaboration of scientists under the auspices of those at Fujita Health University (Toyoake, Japan; www.fujita-hu.ac.jp) identified an additional novel gene for BD, nuclear family I/X (NFIX), and supported three previously implicated genes. The BD ‘risk’ effect is shared between Japanese and European populations. The study was published on January 24, 2017 in the journal Molecular Psychiatry.

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Annual Review 2016 uATF3 could not be detected in most of the patients with sepsis-non-AKI, the qualitative test of uATF3 might be adequate for detecting sepsis-AKI. In contrast, with the baseline of uNGAL, the debates on the cut-off values of uNGAL for sepsis-AKI are still ongoing. The results were also a proof of concept that urine exosomes were an interesting source of urine biomarkers. The study was published in January 7, 2017 in the journal BMC Nephrology.

Year’s Top 100 Clinical Developments mutations which were absent from official catalogues of known blood group variants. The results were exported to an online search engine, www. erythrogene.com, which presents data according to the allele nomenclature developed for clinical reporting by the International Society of Blood Transfusion (Amsterdam, The Netherlands; www. isbtweb.org). The study was published on December 27, 2016, in the journal Blood Advances.

New Genetic Variants Discovered In Blood Group Systems cientists at Lund University (Sweden; www.lunduniversity.lu.se) extracted data from the 1,000 Genomes Project, which provides information on genome variation among 2,504 individuals representing 26 populations worldwide. The study showed that 89% of the genetic variants were previously known, but among the remaining 11% were a total of 1,000 different

FEBRUARY Panel Establishes Biomarker Guidelines for CRC Diagnostics fter reviewing more than 4,000 articles, an expert panel has issued recommendations for testing diagnostic biomarkers in patients with early and advanced colorectal cancer. The multi-disciplinary panel was established by The American

Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) with the objective of establishing standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. Following their review, the panel published its findings in the February 6, 2017 online editions of the American Journal of Clinical Pathology, Archives of Pathology & Laboratory Medicine, the Journal of Molecular Diagnostics and the Journal of Clinical Oncology, from each collaborating organization, respectively.

Breathalyzer Test for Personalized Disease Detection novel breathalyzer device has been developed that enables detection of volatile compounds produced by respiratory viruses such as the influenza virus and other pathogenic microorganisms. A common feature of the inflammatory response in patients who have actually contracted influenza is the generation of a number of volatile products of the alveolar and airway epithelium. These products include a number of volatile organic compounds (VOCs) and nitric oxide (NO). Investigators at the University of Texas (Arlington, USA; www.uta.edu) designed a portable three-sensor array microsystem-based device to detect these biomarkers, which can be used to detect the disease. The breathalyzer device was described in detail in a paper published in the January 20, 2017 online edition of the journal Sensors.

Screening System Detects Four Metabolic Disorders ysosomal Storage Disorders (LSDs) are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability or death. A screening test for newborns that is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe disease, Gaucher disease and Fabry disease has received permission for marketing for these four LSDs. The Seeker System (Baebies, Durham, NC, USA; http://baebies.com) consisting of the Seeker LSD Reagent KitIDUA|GAA|GBA|GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth.

Faster Way of Detecting Bacteria Developed faster way to detect the pathogenic bacteria that may cause patients to become sick has now been developed, giving physicians a better chance at saving lives by proscribing the most suitable antibiotic. Today, patients generally have to wait days to get final test result, but the new method of testing of urine samples, for example, produces positive results in two hours from

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Year’s Top 100 Clinical Developments start to finish versus the days it can take for equivalent hospital laboratory tests. Scientists at Michigan State University (East Lansing, MI, USA; www.msu.edu) developed a point-of-care diagnostic test known as In-Dx. The team is more than one year into a clinical trial that aims to validate the point-of-care diagnostic test, and the preliminary results already look promising. The molecular diagnostic system can identify dangerous bacteria such as Escherichia coli, Staphylococcus infections, and even some superbugs. The test can produce results within two hours using blood, urine, saliva, wound, stool or cerebral spine fluid samples from infected patients.

Bacteria Links Crohn’s Disease to Spondyloarthritis large team of scientists working in conjunction with those at Weill Cornell Medicine College (New York, NY, USA; www.weill.cornell.edu) used fecal samples from patients with inflammatory bowel disease (IBD) to identify bacteria in the gut that were coated with antibodies called immunoglobulin-A (IgA) that fight infection. Using flow cytometry, in which fluorescent probes are used to detect IgA-coated bacterial species, the team discovered that IgA-coated Escherichia coli were abundant in fecal samples from patients with both Crohn’s disease and spondyloarthritis. The study was published on February 8, 2017 in the journal Science Translational Medicine.

long-term poor airflow and the main symptoms include shortness of breath and cough with sputum production and typically COPD worsens over time. A large team of scientists led by those at Brigham and Women’s Hospital (Boston, MA, USA; www. brighamandwomens.org) conducted a genomewide association study of risk for chronic obstructive pulmonary disease (COPD) in a large, multi-ancestry cohort. In addition to identifying 13 new genetic regions associated with COPD, the scientists also discovered four genetic regions that were not previously associated with any lung function trait. Nine of the genetic regions have been identified as playing an important role in lung function. Two have previously shown an association with pulmonary fibrosis; however, the specific forms of

these genetic variants that increase risk for COPD decrease risk for pulmonary fibrosis. The study was published on February 6, 2017 in the journal Nature Genetics.

Rapid Method Identifies Bacteria in Blood Samples desktop diagnosis tool has been developed that detects the presence of harmful bacteria in a blood sample in a matter of hours instead of days. The tool was made possible by a combination of proprietary chemistry, innovative electrical engineering and high-end imaging and analysis techniques powered by machine learning. Bioengineers at the University of California San Diego (La Jolla, CA, USA; www.ucsd.edu) extract-

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Blood Test Differentiates Parkinson’s from Similar Diseases n early stages of disease, it can be difficult to differentiate between Parkinson’s disease and atypical parkinsonism disorders (APDs) like multiple system atrophy, progressive supranuclear palsy and corticobasal degeneration, because symptoms can overlap. Scientists at Lund University (Lund, Sweden; www.med.lu.se) and their colleagues found the blood test was just as accurate as a spinal fluid test at diagnosing whether someone had Parkinson’s or an APD, in both early stages of disease and in those who had been living with the diseases longer. The nerve protein levels were higher in people with APDs and lower in those with Parkinson’s disease and those who were healthy. In the Swedish group, the protein levels averaged around 10 pg/mL. People with multiple system atrophy had levels averaging around 20 pg/mL; those with progressive supranuclear palsy averaged around 25 pg/mL; and those with corticobasal degeneration averaged around 27 pg/mL. The study was published on February 8, 2017 in the journal Neurology.

Genetic Markers Discovered for COPD

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hronic obstructive pulmonary disease (COPD) is a type of obstructive lung disease characterized by LabMedica International December/2017-January/2018

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ed and purified blood from a clinical sample known to be negative for bacteria. The team concluded that the resulting bacteria-specific melt curves are identified by Support Vector Machine learning, and individual pathogen loads are quantified. The study was published on February 8, 2017 in the journal Scientific Reports.

plexity, and cost of clinical diagnostics. This reusable USD 0.01 device is miniaturized to handle small sample volumes and can perform numerous analyses. A study describing the technology was published in the February 6, 2017 online edition of the journal Proceedings of the [U.S.] National Academy of Sciences.

Inexpensive Diagnostic Device May Revolutionize Medical Care

Genetic Test Predicts Success of Bone-Marrow Transplant

radically designed “lab on a chip” diagnostic device is expected to dramatically reduce the cost of isolating and characterizing rare cells and molecules, a process that is of critical importance in diagnosis of common lethal diseases such as malaria, tuberculosis, HIV, and cancer. Investigators at Stanford University (Palo Alto, CA, USA; www.stanford.edu) recently described a nanoparticle-inkjet-printable microfluidics-based platform that fulfilled these criteria and that is expected to significantly reduce the footprint, com-

large team of scientists collaborating with those at the Dana-Farber Cancer Institute (Boston, MA, USA; www.dana-farber.org) found that the most important predictor of patient prognosis was a mutation in the tumor protein p53 (TP53) gene. Robert Coleman Lindsley, MD, PhD, the lead author of the study, said, “‘In deciding whether a stem-cell transplant is appropriate for a patient with MDS, it’s always necessary to balance the potential benefit with the risk of complications. Our findings offer physicians a guide, based on the genet-

ic profile of the disease and certain clinical factors, to identifying patients for whom a transplant is appropriate, and the intensity of treatment most likely to be effective.” The study was published on February 9, 2017 in The New England Journal of Medicine.

Novel Biomarkers Found for Bowel Cancer Treatment olorectal carcinoma (CRC) represents a heterogeneous entity, with only a fraction of the tumors responding to available therapies, requiring a better molecular understanding of the disease in precision oncology. The OncoTrack consortium, (Berlin, Germany www.oncotrack.eu) a public-private group, has conducted one of Europe’s largest collaborative academic-industry research projects to develop and assess novel approaches for identification of new markers for colon cancer. Bodo Lange, PhD, CEO at Alacris Theranostics (Berlin, Germany; www.alacris.de) and a co-author of the study, said, “Our findings provide major new insights into the molecular landscape of colorectal cancer, including the identification of novel alterations, which can be further exploited for advancing understanding of this lethal tumor type and for personalizing therapies.” The study was published on February 10, 2017 in the journal Nature Communications.

Proteomic Assay Pinpoints Cause of Upper Respiratory Disease novel proteomics assay performed on nasal wash fluid rapidly determines if runny nose and other respiratory symptoms are due to cold or flu virus infection. Investigators at Duke University (Durham, NC, USA; www.duke. edu) reported in the February 20, 2017 online edition of the journal EBioMedicine that unbiased proteomic discovery analysis of nasal wash fluid identified 3285 peptides corresponding to 438 unique proteins, and revealed that infection with H3N2 induced significant alterations in protein expression. “Every day, people are taking time off from work, going to emergency rooms, urgent care or their primary care doctors with symptoms of an upper respiratory infection,” said senior author Dr. Geoffrey S. Ginsburg, director of the center for applied genomics & precision medicine at Duke University, “looking for these proteins could be a relatively easy and inexpensive way of learning if a person has a viral infection, and if not, whether the use of antibiotics is appropriate.”

Diagnosis of Skin Cancer without Biopsy esearchers have developed a noninvasive method that accurately identified skin cancer by using multiphoton microscopy to quickly detect abnormal clusters of mitochondria in skin cells. A group of international collaborators led by co-senior author Irene Georgakoudi, PhD, of Tufts University (Medford, MA, USA; www.tufts. edu), found that mitochondria behave very differently in healthy versus cancerous tissue. They used a laser microscopy technique that takes advantage of characteristics of the mitochondrial compound nicotinamide adenine dinucleotide (NADH), which naturally fluoresces without injecting any dye

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Annual Review 2016 or contrast agent into the individuals being screened. They found that NADH can be detected using multiphoton microscopy to provide diagnostically useful information about the organization of the mitochondria in skin cells. The study, by Pouli D et al, was published November 30, 2016, in the journal Science Translational Medicine.

MARCH Test for Earlier Detection Of Transplant Rejection method has been discovered that appears to provide earlier warning of organ transplant rejection compared to standard methods, and requires only a blood test rather than a more invasive and painful needle biopsy. Scientists at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, PA, USA; www.med.upenn.edu) showed that they could iso-

Year’s Top 100 Clinical Developments late and detect donor-tissue exosomes in a different type of transplant: kidney transplant, currently the most common type of organ transplant. In this case, the team found that they could isolate and quantify donor-kidney exosomes not just in blood but also in urine, thus potentially enabling urine tests which are even less invasive than blood tests. Ali Naji, MD, PhD, a Professor of Surgery and senior author of the study said, “I believe that analyses of exosomes from transplanted organs will ultimately provide a very powerful and unprecedented ability to understand the conditional state of the organ as a whole.” The study was published on March 20, 2017 in the Journal of Clinical Investigation.

Test Markers Identify Cancer DNA and Pinpoint Tumor Location team of molecular geneticists has developed a diagnostic tool that identifies circulating cancer DNA and determines the organ in which the tumor is located. Investigators at

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the University of California San Diego (USA; www.ucsd.edu) based their method on the presence of methylation haplotype blocks in the genome. It is thought that identifying these statistical associations and few alleles of a specific haplotype sequence can facilitate identifying all other such polymorphic sites that are nearby on the chromosome. Using methylation haplotype data, the investigators compiled a database of the complete CpG methylation patterns of 10 different normal tissues (liver, intestine, colon, lung, brain, kidney, pancreas, spleen, stomach, and blood). They then analyzed tumor and blood samples from cancer patients to assemble a database of cancer-specific genetic markers. Using this database the investigators demonstrated quantitative estimation of tumor load and tissue-of-origin mapping in the circulating cellfree DNA of 59 patients with lung or colorectal cancer. The method was described in detail in the March 6, 2017, online edition of the journal Nature Genetics.

Newly-Discovered Gene Can Cause Sudden Cardiac Death esearchers have found that mutations in the gene Cadherin 2 (CDH2) can lead to sudden death among young people and athletes with genetically inherited arrhythmogenic right ventricular cardiomyopathy (ARVC), which predisposes patients to cardiac arrest and is a major cause of unexpected death in seemingly healthy young people. The discovery is the result of an international collaboration led by a team headed by Bongani Mayosi, professor of cardiology at University of Cape Town (South Africa) and Groote Schuur Hospital (South Africa), along with researchers of Auxologico Institute of Milan (Italy) and University of Pavia (Italy), and McMaster University (Ontario, Canada; www.mcmaster.ca) and Hamilton Health Sciences (Ontario, Canada). Identifying the gene helps to clarify genetic mechanisms underlying ARVC, and makes early detection of ARVC possible in otherwise unsuspecting people. Often, the diagnostic clinical signs of the disease only become clear after many years. Now, if someone with ARVC is a carrier of a defective CDH2 mutation, other family members who are genetically affected can be quickly identified and preventive strategies initiated immediately. The study, by Mayosi BM et al, was published March 8, 2017, in the journal Circulation: Cardiovascular Genetics.

Immunoproteomics Identifies New Biomarkers for Crohn’s Disease Connecting Buyers with Suppliers Worldwide Reach new sources of supply Identify latest products and technologies Send inquiries directly to suppliers Receive latest product alerts Chat live with suppliers TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dynamic network. Solely dedicated to medical products, TradeMed is the premier choice for medical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget.

sing a new screening approach, a study aimed at developing a better blood test for Crohn’s disease (CD) successfully identified several antibodies that could serve as diagnostic markers. The study, based on links between CD and the immune response against self-proteins, was led by scientists Josh LaBaer and Ji Qiu of the Biodesign Institute of Arizona State University (AZ, USA; www.asu.edu), along with gastroenterologists Shabana Pasha and Jonathan Leighton from Mayo Clinic Arizona. "No single biomarker is going to be predictive and meet clinical needs," said LaBaer, "Only a panel of biomarkers, made of individually validat-

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Year’s Top 100 Clinical Developments ed biomarkers, will achieve the best performance in the clinic. But we are excited about the potential of this immunoproteomics approach for CD and will work to discover additional biomarkers." The study, by Wang H et al, was published February 14, 2017, in the Journal of Crohn’s and Colitis.

Mobile Device Rapidly Detects Zika and Related Viruses team of biologists and engineers have developed a smartphone-controlled, batteryoperated, low-weight diagnostic technology that costs as little as USD 100 and can detect Zika, dengue, and chikungunya viruses within 30 minutes. The same platform can also be adapted to detect other human or animal pathogens. The team, from Sandia National Laboratories (Livermore, CA, USA; www.sandia.gov), used smartphone technology as a key feature: “In addition to creating an app that serves as a simple interface to operate the device, we were able to adapt smartphone camera sensors to replace traditional laboratory sample analysis tools, allowing for unprecedented mobility,” said lead author Aashish Priye. The study, by Priye A et al, was published online March 20, 2017, in the journal Scientific Reports.

complex steps, various pieces of equipment, and experienced personnel, investigators at Fraunhofer Institute for Cell Therapy & Immunology (Leipzig, Germany; www.izi.fraunhofer.de) developed an innovative prototype lab-on-a-chip platform capable of automating the process in a single instrument. Details of the device were published in the March 22, 2017, online edition of the journal Future Science OA.

Low-Cost POC Assay Developed For Reliable Blood Grouping fast, accurate, and versatile paper-based blood test has been developed that could be performed without the need for specialized equipment providing a more cost-effective

strategy for blood grouping. The blood typing assay is based on the color change that occurs when a common pH indicator dye reacts with blood. Medical scientists at the Third Military Medical University, Chongqing, China (www.dapinghospital.com) concluded that the assay not only provides a new strategy for blood grouping but can also be used in timeand resource-limited situations, such as war zones, in remote areas, and during emergencies. Characterized by an intensified and streamlined workflow capability, the proposed blood-grouping assay may be further developed into highly compact and fully automatic platforms that are highly efficient and economical, making large-scale manufacturing possible. The study was published on March 15, 2017, in the journal Science Translational Medicine.

Blood Test Identifies Early-Stage Tumors he development of a blood test that screens for methylated DNA from tumor cells may herald an era of simpler and more precise cancer diagnostics. Currently there is no existing cell-free DNA (cfDNA)-based method that is able to simultaneously detect cancer and predict its tissue of origin. To fill this gap investigators at the University of California, Los Angeles (USA; www.ucla.edu) have proposed a novel method, CancerLocator, which simultaneously infers the proportion and tissue of origin of circulating DNA in a blood sample using genome-wide DNA methylation data. CancerLocator identifies specific methylation patterns in circulating cancer DNA from different cancer types and compares the patterns to those in a tumor epigenetics database. Since DNA from tumor cells enters the bloodstream in the earliest stages of cancer, this approach offers a method for early detection of the disease. The CancerLocator program was described in the March 24, 2017, online edition of the journal Genome Biology.

Lab-on-a-Chip Platform Designed for Detection Of Pathogens team of German bioengineers has developed an integrated and automated lab-on-a-chip platform for sample preparation and nucleic acid-based detection of pathogens in various liquid media. Since DNA-based detection of the pathogens in liquid samples demands many

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Year’s Top 100 Clinical Developments

Simple Urine Test Helps Track ALS Progression

tients, and that is not sufficient.” The study was published in the April 2017 edition of the journal Psychoneuroendocrinology.

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cientists at Flinders University (Adelaide, Australia; www.flinders.edu.au) and their colleagues performed a prospective cohort study in which urine samples from patients with amyotrophic lateral sclerosis (ALS) and controls were collected. To evaluate urinary neurotrophin receptor p75 extracellular domain (p75ECD) levels, the team used a sandwich enzyme-linked immunoassay (ELISA) and validation included intra-assay and inter-assay coefficients of variation. The researchers concluded that the assay for urinary p75ECD is analytically robust and shows promise as an ALS biomarker with prognostic, disease progression, and potential pharmacodynamic application. Baseline urinary p75ECD provides prognostic information and is currently the only biological fluid–based biomarker of disease progression. The study was published ahead of print on February 22, 2017, in the journal Neurology.

n innovative blood culture microbial detection system is now commercially available in countries that recognize CE marking and in the USA, and is the first continuously monitoring blood culture microbial detection system to offer “Load & Go” technology. The BacT/ ALERT VIRTUO system (bioMérieux, Marcy l'Etoile, France; www.biomerieux.com), offers powerful proprietary algorithms, high thermal stability and superior optics, which enhance blood culture performance for more rapid time to detection. This translates into faster identification of bloodstream infections. The blood culture system further enriches the BacT/ALERT product line for blood culture. It offers an integrated configuration with scalable incubation capacity from 428 to 1,712 cells and facilitates the management of high volumes of blood cultures.

Markers Predict Recurrence of Atrial Fibrillation after Ablation

Blood Test Predicts Effectiveness of Anti-Depression Medication

esearchers at the Intermountain Medical Center Heart Institute (Salt Lake City, UT, USA; www.ihc.com) have found that certain circulating microRNA could serve as markers in screening tools to help distinguish which patients with atrial fibrillation (AFib) will be more versus less likely to benefit from various therapy options. Ablation cures AFib in 60-70% of patients, but multiple procedures are required for some. The researchers hope their findings will lead to development of tests that will help doctors determine which treatments are more likely to work for different patients, including those who wouldn’t benefit from ablation. The study was presented at the American College of Cardiology’s Scientific Session on March 18, 2017, in Washington, DC, USA.

finger-prick blood test could help doctors to choose which medication is most likely to succeed in treating depression as levels of C-reactive protein in the blood predict which antidepressant treatments are most likely to lead to successful outcomes in patients with depression. Scientists at the University of Texas Southwestern Medical Center (Dallas, TX, USA; www.utsouthwestern.edu) and their colleagues found that the treatment arms did not differ in depressive symptom or side effect outcomes. Madhukar Trivedi, MD, a professor and senior author of the study, said, “Both patients and primary-care providers are very desperately looking for markers that would indicate there is some biology involved in this disease. Otherwise, we are talking about deciding treatments from question-and-answer from the pa-

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Automated Blood Culture System Receives FDA Clearance

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CE Mark Granted to Urine Test for Bladder Cancer he European Union’s CE Mark was granted to Nucleix’s (Rehovot, Israel; www. nucleix.com) Bladder EpiCheck test, aimed to help urologists to better monitor their bladder cancer patients. Bladder EpiCheck is a urine test that includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis. This regulatory approval follows the completion of a multi-center, prospective, and blinded clinical study that was performed in leading urology centers in Europe. Nucleix develops non-invasive molecular cancer diagnostic tests based on identification of subtle epigenetic changes in methylation patterns. Nucleix technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection.

Circulating TB Antigens Allows Rapid Diagnosis of Active Disease rapid and quantitative blood-based assay with high sensitivity and specificity for active Mycobacterium tuberculosis (Mtb) infections has been developed that can be used to monitor responses to anti-mycobacterial therapy. A team of scientists led by those at the Arizona State University’s Biodesign Institute (Tempe. AZ; USA; www.asunow.asu.edu) have identified Mtb-specific peptide fragments and developed a method called NanoDisk-MS, to rapidly quantify their serum concentrations, using antibody-labeled and energy-focusing porous discoidal silicon nanoparticles (nanodisks) and high-throughput mass spectrometry (MS) to enhance sensitivity and specificity. Tony Ye Hu, PhD, an associate professor and lead author of the study said, “We are particularly excited about the ability of

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Year’s Top 100 Clinical Developments our high-throughput assay to provide rapid quantitative results that can be used to monitor treatment effects, which will give physicians the ability to better treat worldwide TB infections.” The study was published on March 27, 2017, in the journal Proceedings of the National Academy of Sciences.

Innovative Von Willebrand Factor Test Launched in US center for blood diseases has launched a new test in the United States to more accurately measure activity of von Willebrand Factor (VWF), one of the blood-clotting proteins, for people with the inherited bleeding disorder von Willebrand disease (VWD). The new assay – “VWF GPIbM Activity” – was launched by BloodCenter of Wisconsin (Milwaukee, WI, USA; www.bcw.edu), part of Versiti. The test employs patented technology previously not used in the USA that provides more precise measurement of VWF plateletbinding activity – critical for making an accurate diagnosis of VWD. BloodCenter of Wisconsin is the first organization to make this test available in the US in a clinical laboratory setting. This development is an exciting advancement in von Willebrand disease diagnostics,” said Johnathan Roberts, MD, of the Bleeding & Clotting Disorders Institute (Peoria, IL, USA), “This assay will reduce some of the diagnostic challenges in caring for individuals with VWD.”

only pay attention to women who have other clear risk factors. However with the help from a palm-sized plastic rectangle doctors are hoping to minimize the problem of premature deliveries. The chip is designed to predict, with up to 90% accuracy, a woman's risk for a future preterm birth. Scientists at Brigham Young University (Provo, UT, USA; https://byu.edu) have developed a microfluidic device that uses pHmediated solid phase extraction (SPE) for the enrichment and elution of preterm birth (PTB) biomarkers. Adam T. Woolley, PhD, a chemistry professor and senior author of the study, said, “Among other benefits, the device is cheap, small and fast: once fully developed, it will help make detecting biomarkers a simple, automated task.” The study was published on March 8, 2017, in the journal Electrophoresis.

LAMP-based Assay Launched For Detection of Malaria new molecular diagnostic kit for the detection of the malaria parasite has been described as being up to 80,000 times more sensitive at detecting the malaria parasite than current testing options. The illumigene Malaria test was developed by Meridian Bioscience, Inc. (Cincinnati, OH, USA; www.meridianbioscience. com). It uses loop mediated isothermal amplification (LAMP) technology, and is the tenth item on Meridian's list of illumigene assays for the diagnosis of infectious diseases, which includes C. difficile, whooping cough, Group A and B Streptococcus, mycoplasma, and herpes simplex virus. illumigene

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Novel Flu Test Developed To Speed Up Treatment novel way of using a swab test has been developed which can rapidly diagnose influenza and other viral infections in patients with severe respiratory conditions, resulting in shorter courses of antibiotics and less time in hospital. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalizing isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. Doctors and their colleagues at University Hospital Southampton (UK; www.uhs.nhs.uk) concluded that patients who had the point-ofcare test got the right treatment for their lung condition faster. In addition, patients who tested positive for influenza in the point-of-care testing group were appropriately isolated in a side room and given antiviral medication more often and sooner than those in the standard care group. The study was published on April 6, 2017, in the journal Lancet Respiratory Medicine.

Lab-On-A-Chip Designed to Minimize Preterm Births

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Annual Review 2016 Malaria is user-friendly, does not require special training or capital investment, yields results in under one hour, and the testing materials can be stored at room temperature. “This is a major step forward in the fight to bring better care to those infected with malaria and to stop its spread,” said John A. Kraeutler, CEO of Meridian Bioscience.

Mass Spectrometry Identifies Bacteria Resistant to Colistin method using mass spectrometry has been successfully developed to quickly and accurately diagnose drug-resistant bacterial infections, as well as to distinguish between the two main mechanisms of resistance. The research was a collaboration led by Dr. Laurent Dortet, from South Paris University (Paris, France), and Dr. Gerald Larrouy-Maumus and Prof. Alain Filloux from Imperial College London (London, UK; www3.imperial. ac.uk). The team tested Escherichia coli and Klebsiella pneumoniae, both members of Enterobacteriacae. Some strains have become resistant to nearly all available antibiotics. Colistin often remains the only treatment option for these multidrug resistant bacteria, but some strains have now also developed colistin resistance. “The rapid detection of colistin resistance will be of enormous value in healthcare. It will enable early interventions to control transmission, protect patients, and improve individual patient management” said Prof. Alison Holmes, of Imperial College. The study was presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases held on April 22-25, 2017 in Vienna, Austria.

Novel Assay Discriminates Several Aspergillus Species nvasive aspergillosis (IA) is mainly caused by Aspergillus fumigatus and when diagnosis is made early and first line therapy with voriconazole is initiated promptly, a relatively low mortality is observed. However, over the past decade, azole resistance has emerged worldwide and poses a threat as IA with azole-resistant A. fumigatus is associated with high mortality of 88%. Scientists at the Erasmus University Medical Center (Rotterdam, The Netherlands; www.erasmusmc.nl) used a multiplex real-time polymerase chain reaction (PCR) assay to detect Aspergillus species and mutations in the Cyp51A gene of A. fumigatus. The AsperGenius multiplex real-time PCR assay (PathoNostics, Maastricht, The Netherlands; www.pathonostics.eu) was performed on strains obtained from lung biopsy in one case and from pleural mass biopsy the second case. The researchers concluded that the assay can be used to rapidly discriminate A. fumigatus, A. lentulus and A. felis. The study was published in the March 2017 issue of the journal Diagnostic Microbiology and Infectious Disease.

MAY Molecular Test Speeds Up Multiple Sclerosis Diagnosis

pioneering blood test has been introduced that speeds up multiple sclerosis (MS) diagnosis to just seven days. Current testing

Year’s Top 100 Clinical Developments methods such as magnetic resonance imaging scans take much longer to reach a diagnosis because they rely on measuring the progress of irreversible neurological damage. Molecular diagnostics startup IQuity (Nashville, TN, USA; https://iquity.com) have introduced IsolateMS, which works by assessing patients’ RNA levels and gene expression in a blood sample. Previous IQuity’s research showed that autoimmune disease patients exhibit distinct long non-coding RNA (lncRNA) expression patterns in their blood that are different from individuals without the disease, suggesting that these RNA markers could be a way to diagnose autoimmune conditions. Chase Spurlock, PhD, CEO of IQuity, said, “The 90% accuracy rate of IsolateMS should give providers and patients a great deal of confidence in their results. This test augments existing clinical practice and eliminates the period of uncertainty that can accompany an MS diagnosis. IsolateMS allows patients and providers to begin discussing next steps immediately.”

Novel Assay Detects SV in Children novel rapid assay applies a nicking-enzyme amplification reaction to easily and rapidly detect respiratory syncytial virus (RSV) in children hospitalized with acute respiratory-tract infections. Scientists at the University Hospital Heidelberg (Heidelberg, Germany; www.heidelberg university-hospital.com) used the Alere i RSV assay (Alere Inc, Waltham, MA, USA; www.alere.com) and correctly identified all samples positive for RSV. The assay demonstrated 100% sensitivity (95% confidence interval, CI: 93% to 100%), and 97% specificity (95% CI: 89% to 100%). The test results compared favorably with real-time reverse transcription polymerase chain reaction (RT-PCR) testing. Sarah Valerie Schnee, lead author of the study, “The total test duration, including three minutes for heating the lysis buffer, was five minutes for positive results and 13 minutes for negative results. The availability of sensitive, rapid RSV tests is critical to optimize care management, minimize unnecessary antibiotic use, and provide targeted infection control.” The study was presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases held on April 22-25, 2017 in Vienna, Austria.

New Technique Tests Therapies For Cancer Metastasis new laboratory technique has been developed that can rapidly test the effectiveness of treatments for life-threatening, breast cancer metastases in bone. Until now, there has not been an effective laboratory platform to study metastatic tumors in their new microenvironment. Scientists at the Baylor College of Medicine (Houston TX, USA; www.bcm.edu) and their colleagues determined that the bone-in culture maintains the microenvironmental characteristics of bone metastasis in living animal models, and the cancer cells maintain the gene expression profile, the growth pattern and their response to therapies. Using the bone-in model, the investigators determined that the drug danusertib preferentially inhibits bone metastasis. They also found that other drugs stimulate the growth of slowgrowing cancer cells in the bone. In addition to determining the effect of drugs in the growth of metas-

tasis in bone, the bone-in culture can be used to investigate mechanisms involved in bone colonization by cancer cells. The study was published on April 21, 2017 in the journal Nature Communications.

Blood Group May Affect Heart Attack Risk ealthcare professionals should consider a person’s blood group when assessing their cardiovascular risk as people with A, B, and AB blood types may be at greater risk of cardiovascular events, particularly heart attacks, than individuals with O blood types. Scientists at the University Medical Centre Groningen (The Netherlands; www.umcg.nl) conducted a meta-analysis of studies that reported participants’ blood types and the incidence of cardiovascular events, including heart attack, heart disease, heart failure, and cardiovascular death. The scientists noted the that individuals with non-O blood types have higher concentrations of a blood-clotting protein called von Willebrand factor, which previous studies have linked to thrombotic events. Additionally, they point out that people with non-O blood groups, especially those with an A blood type, tend to have higher cholesterol levels, which is a known risk factor for poor cardiovascular health. The study was presented at the annual meeting of the European Society of Cardiology, held April 29 to May 2, 2017 in Paris, France.

New Test May Predict Gestational Diabetes Better estational diabetes is a type of diabetes that occurs during a woman’s pregnancy, increasing the mother’s risk of delivering a large-for-gestational-age baby, which can lead to pre-term birth, fetal injury, perinatal mortality and cesarean delivery. Scientists at Brigham and Women’s Hospital (Boston, MA, USA; www. brighamandwomens.org) concluded that as nonenzymatic glycation inactivates the complement inhibitor CD59, forming glycated CD59 (GCD59), they could therefore use a sensitive and specific enzyme-linked immunosorbent assay (ELISA) for GCD59 in blood, and they showed that plasma GCD59 levels are significantly higher in individuals with type 2 diabetes and independently predict the response to the oral glucose tolerance test. Jose A. Halperin, MD, a hematologist and senior author of the study said, “This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who are at risk for failing the glucose challenge test and are at higher risk for developing gestational diabetes. These results suggest that a single measurement of plasma GCD59 during weeks 2428 may also help stratify the risk for delivering larger infants among women with gestational glucose intolerance.” The study was published in the April 2017 issue of the journal Diabetes Care.

POC Test Advances Hepatitis C Diagnosis

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Annual Review 2016 treatment service for some of the most vulnerable people in Australia and the world. Point-of-care hepatitis C virus (HCV) RNA testing offers an advantage over antibody testing, which only indicates previous exposure, enabling diagnosis of active infection in a single visit. The performance of a HCV Viral Load assay with venipuncture and finger-stick capillary whole-blood samples has been evaluated. Scientists at the Kirby Institute (Sydney, Australia; https://kirby.unsw.edu.au) compared the sensitivity and specificity of the Xpert HCV Viral Load test for HCV RNA detection (Cepheid, Sunnyvale, CA, USA; www.cepheid.com) by venipuncture and finger-stick collection with their gold standard, the Abbott RealTime HCV Viral Load assay (Abbott Laboratories, Abbott Park, IL, U.S.A www.molecular. abbott). The Xpert HCV Viral Load test is a quantitative test for rapid measurement of Hepatitis C virus Viral Load and confirmation of HCV infection delivers on-demand results in less than two hours. The study was published on April 21, 2017, in the journal The Lancet Gastroenterology & Hepatology.

Rapid Assay Monitors Influenza Virus Susceptibility cientists at the Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA; www.cdc.gov) and their international colleagues used a new rapid assay for detecting oseltamivir resistance in influenza virus, iART. The rapid prototype iART assay was developed by Becton Dickinson (Triangle Park, NC, USA; www. bd.com). The researchers concluded that their data showed that the iART assay can become a valuable tool for surveillance laboratories. The assay offers a fast means for detecting viruses displaying reduced inhibition/highly RI (RI/HRI) against oseltamivir in either isolates or clinical specimens. It is a simple approach where signal measurement, data analysis

Year’s Top 100 Clinical Developments and interpretation are done by a compact portable device. The study was published on May 4, 2017, in the journal Eurosurveillance.

Simple Urine Test Helps Patients with COPD n innovative technology could hugely improve the quality of life for people who suffer from the serious lung condition called Chronic Obstructive Pulmonary Disease. The urine test alerts these people that they are about to suffer a life-limiting lung attack. Scientists at the University of Leicester (UK; www.le.ac.uk) in partnership with Mologic (https://mologic.co.uk) have unveiled the simple in-home Headstart that test has already passed the first stage of the development process. Prof. Paul Davis, chief scientific officer and Mologic co-founder, said, “We accepted the challenge of coming up with a new way to help COPD patients understand, monitor and control what’s going on in their vulnerable lungs. Our response to the challenge was to develop a simple, low-cost test, which worked in a similar way to a pregnancy test, only this one can predict impending lung problems. The test is simple enough for patients to use themselves at home, so this puts them at the center of their own care, empowering them to take control.

Rapid POC Test Detects Influenza ddressing the perennial threat of a major flu pandemic, Prof. Paul Yager, University of Washington, (Seattle, WA, USA; www. washington.edu), and colleagues have developed fast, easy-to-use point-of-care (POC) diagnostic test for influenza that could head off rapid spread of the virus during an outbreak. Preliminary clinical testing of the prototype device were encouraging. The test is based on a sandwich immunoassay for influenza virus nucleoprotein and runs in a 2-dimen-

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sional paper network format. The device contains all reagents and required no dedicated instruments.

JUNE Simple Method Measures Bacterial Tolerance to Antibiotics cientists at the Hebrew University (Jerusalem, Israel; www.huji.ac.il) developed a tolerance metric called the minimum duration for killing 99% of the population (MDK99). The protocol, which can be performed manually or using an automated robotic system, involves exposing populations of approximately 100 bacteria in separate microwell plates to different concentrations of antibiotics for varied time periods, while determining the presence or lack of survivors. Nathalie Q. Balaban, PhD, a professor and senior study author, said, “If implemented in hospital clinical microbiology laboratories, MDK99 could enable the efficient classification of bacterial strains as tolerant, resistant, or persistent, helping to guide treatment decisions. In the end, understanding tolerance and finding a way to combat it could significantly reduce the ever-growing risk of resistance.” The study was published on June 20, 2017, in the Biophysical Journal.

Blood Test Predicts Huntington’s Disease n international team of scientists collaborating with the University College of London (UK; www.ucl.ac.uk) investigated whether neurofilament light protein NfL (also known as NF-L) in blood is a potential prognostic marker of neurodegeneration in patients with Huntington’s disease. The team used a blood test to measure NfL, a protein released from damaged brain cells, which has been linked to other neu-

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Annual Review 2016 rodegenerative diseases but has not been studied in the blood of Huntington’s disease (HD) patients before. The international project followed 366 volunteers for three years. The scientists found that levels of the brain protein were increased throughout the course of HD, even in carriers of the HD genetic mutation who were many years from showing symptoms of the disease. HD mutation carriers had neurofilament concentrations that were 2.6 times that of the control participants, and the level rose throughout the disease course from premanifest to stage 2 disease. In the group who had no symptoms at the start of the study, the level of neurofilament predicted subsequent disease onset, as volunteers with high neurofilament levels in the blood at the start were more likely to develop symptoms in the following three years. The study was published on June 7, 2017, in the journal Lancet Neurology.

Cardiac Troponin Test Uses Single Molecule Counting Technology ingulex (Alameda, CA, USA; www.singulex. com), a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, announced it has applied the CE Mark to its ultrasensitive troponin I assay (cTnl), the first offered on the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD). Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.

New Test Accurately Detects Latent HIV cientists at the University of Pittsburgh (PA, USA; www.pitt.edu) and their colleagues developed a sensitive assay that can accurately and rapidly quantify inducible, replication-competent latent HIV-1 from resting CD4+ T cells, which is essential for HIV-1 eradication studies. The developed test is called TZA and it works by detecting a gene that is turned on only when replicating HIV is present, thereby flagging the virus for technicians to quantify. Phalguni Gupta, PhD, a professor and senior author of the study, said, “Using this test, we demonstrated that asymptomatic patients on antiretroviral therapy carry a much larger HIV reservoir than previous estimates, as much as 70 times what the QVOA test was detecting. Because these tests have different ways to measure HIV that is capable of replicating, it is likely beneficial to have both available as scientists strive toward a cure." The study was published on May 29, 2017, in the journal Nature Medicine.

Year’s Top 100 Clinical Developments New Diagnostic Products Detect Prostate Cancer

Next-Generation Hematology Analyzer Introduced

DxHealth SA (Herstal, Belgium; http:// mdxhealth.com) has announced the European launch of its CE-marked UrNCollect device for use with the SelectMDx in vitro diagnostic (IVD) PCR test kit for prostate cancer. UrNCollect is a user-friendly device that enables the hygienic and standardized collection of the first 16 milliliters of the urine stream and reduces laboratory errors by automating preservative mixing without additional handling or pipetting. The SelectMDx PCR kit enables diagnostic laboratories with manual and automated RNA extraction and PCR platforms to perform the liquid biopsy test in their own facility. Laboratories that are not equipped to use the IVD PCR kit can have samples processed at MDxHealth’s state-of-the-art ISO-certified diagnostic facilities in Nijmegen, the Netherlands or Irvine, California, USA. A technical validation study that assessed and confirmed the robustness, reproducibility, and interlaboratory performance of SelectMDx was published in the May 11, 2017, issue of the journal Translational Medicine Communications.

he Alinity hq analyzer (Abbott, Abbott Park, IL, USA; www.corelaboratory.abbott) for hematology is now CE Marked and available in Europe and other countries that recognize CE Mark. The analyzer is the first in the Alinity hematology series of instruments to be commercially released, and is part of the planned integrated hematology system designed to address the productivity needs of the high-volume laboratory. The Alinity hq was built from the ground up to help solve every day operational challenges and anticipated future needs for high-volume laboratories. Luis de Luzuriaga, divisional vice president and general manager for Abbott’s hematology business, said, “The Alinity hq launch is a key milestone for Abbott’s hematology business unit. With the Alinity family of harmonized systems, Abbott aims to simplify diagnostics testing across laboratory disciplines and help our customers improve patient outcomes.”

Blood Test Detects Heart Attack Risk in Lupus Patients specific biomarker detected in the blood of lupus patients with no symptoms of cardiovascular disease (CVD), thought to be at low risk of CVD based on traditional risk factors, is associated with the presence of atherosclerosis. A team of scientists at the Bichat Hospital (Paris, France; www.aphp.fr) concluded that the risk of having fatty deposits (plaques) in the carotid arteries that deliver blood to the brain due to atherosclerosis was increased by a factor of eight times in those lupus patients who had a biomarker known as High Sensitivity Cardiac Troponin T (HS-cTnT) in their blood. Karim Sacre, MD, a professor and lead author of the study, said, “The results of our study raise the possibility that this easily measured biomarker could be introduced into clinical practice as a more reliable way of evaluating CVD risk in lupus patients.” The study was presented at the Annual European Congress of Rheumatology (EULAR) held June 14-17, 2017, in Madrid, Spain.

PCR Test for Vaginal Pathogens Approved for Use molecular diagnostic test that identifies the three pathogens most commonly associated with vaginitis has been approved for sale as a diagnostic tool in the United States. Investigators at Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) developed the test, which was subsequently licensed for marketing by BD Diagnostics (Franklin Lakes, NJ, USA; www. bd.com) under the name BD MAX Vaginal Panel for use with the BD MAX System. The BD MAX System offers an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays.

Fully Automated Coagulation System Launched he CP3000 coagulation system (Sekisui Diagnostics, Maidstone, UK; www.sekisui diagnostics.com) features small sample volume requirements, and offers high throughput in a compact footprint. With a broad assay menu and rapid result turnaround time, the CP3000 coagulation system can meet the workflow needs of laboratories of all sizes, while providing high quality and reliable results. The system offers an expanded menu of barcoded reagents to reduce data entry errors. With an ability to visualize and automate Mixing Studies, the CP3000 coagulation system can help clinicians quickly interpret results. The system also connects to the ACCELERATOR a3600 (Abbott, Abbott Park, IL, USA; www. corelaboratory.abbott) automation track, which provides additional flexibility to meet the needs of the laboratory.

Reliable Test Sought For Anti-Phospholipid Antibody Syndrome sing patient-derived antibodies, researchers at the University of Geneva (UNIGE; Geneva, Switzerland; www. unige.ch/international/en) and the Geneva University Hospitals (HUG) have succeeded to identify a peptide motif in the protein B2GP1 recognized by antibodies characteristic of the autoimmune disease anti-phospholipid antibody syndrome (APLAS). This is enabling the researchers to develop a more accurate diagnostic assay for patients with this disease, and could also lead to better treatment options. On the importance of this discovery, Karim Brandt, researcher at UNIGE’s faculty of medicine, said: “The current diagnostic tests use the entire protein, which reduces its specificity and leads to standardization issues. Consequently, two tests are required at an interval of 12 weeks after a thrombotic episode or following one or more miscarriages. Our new test specifically targets this pathogenic antibody, with rapid and more accurate results.” The

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study, by de Moerloose P et al, was published May 2017 in the journal Haematologica.

FDA Approves Fourth-Generation Blood Test

Genetic Test Identifies Risk of Anal Cancer

he FDA approved test QuantiFERON-TB Gold Plus (QFT-Plus) is QIAGEN’s (Germantown, MD, USA and Hilden, Germany; www.qiagen.com) fourth-generation blood test for detecting latent-TB infection. QFT-Plus builds on the foundation of QuantiFERON-TB Gold (QFT), the third-generation version of Qiagen’s leading interferon gamma release assay (IGRA). QFT is well proven, with a vast body of clinical evidence, as a cost-effective and efficient tool for TB infection testing. Availability in the US is planned to begin later this year (2017). With the addition of proprietary CD8+ technology, QFT-Plus represents a key milestone in the development of diagnostic tests for latent-TB infection.

new genetic test developed by scientists at the Queen Mary University of London (UK; www.qmul.ac.uk) offers an accurate and inexpensive way to find and treat those at highest risk of anal cancer, a disease with growing incidence in people who have sex with men (MSM) and people with human immunodeficiency virus (HIV). Attila T. Lorincz, PhD, a professor and lead author of the study said, “We believe this new set of biomarkers goes a long way to indicating which men and women are at risk of developing anal cancer. Now that we can identify those at risk, and conversely, those not at risk, we hope to see a big improvement, by making sure that anoscopies and laser or chemical surgery are only given to those who need it.” The study was published on May 18, 2017, in the journal Oncotarget.

JULY Haptoglobin Test Enables New Diabetes Treatment breakthrough ELISA kit developed by BioRap Technologies (Haifa, Israel; www.biorap.com), based on the Haptoglobin 2-2 (Hp 2-2) protein marker, can identify diabetes patients at higher risk of developing lethal cardiovascular disease or renal failure, thereby enabling them to take Vitamin E, a nutritional supplement shown to be of great benefit to them but posing harm to the remaining non HP 2-2 diabetic population. A CE mark application for the test is currently in progress, with FDA certification planned for the US market. BioRap's Hp typing test has been validated for 99% accuracy by eight different clinical studies, and is easily and rapidly performed from 20 μl of serum or plasma using the ELISA based kit (www.haptoglobintyping.com).

Microscopy Technique Advances Biopsy Diagnosis xpansion microscopy (ExM), is a method for improving the resolution of light microscopy by physically expanding a specimen, but has not been applied to clinical tissue samples. In this ExM method a tissue sample is expanded to 100 times its original volume before imaging it. Scientists at Massachusetts Institute of Technology (Cambridge, MA, USA; www.mit.edu) and their colleagues developed a clinically optimized form of ExM that supports nanoscale imaging of human tissue specimens that have been fixed with formalin, embedded in paraffin, stained with hematoxylin and eosin, and/or fresh frozen. The method, which they call expansion pathology (ExPath), converts clinical samples into an ExM-compatible state, then applies an ExM protocol with protein anchoring and mechanical homogenization steps optimized for clinical samples. The study was published on July 17, 2017, in the journal Nature Biotechnology.

urinary EVs are reflective of preeclampsia-related altered podocyte protein expression. Furthermore, renal injury in preeclampsia associated with an elevated urinary podocin+ EVs-tonephrin+ EVs ratio and may be mediated by prolonged exposure to cell free HbF. Vesna D. Garovic, MD, a professor of Nephrology and Hypertension and the senior author of the study, said, “This increased amount of fetal haemoglobin in preeclampsia may be causing the release of podocyte fragments in the urine. We hope that this information will result in improved diagnostic procedures in women with pre-eclampsia; however, additional studies in larger numbers of patients and across different types of preeclampsia are needed.” The study was published on July 20, 2017, in the journal Clinical Journal of the American Society of Nephrology.

Liquid Biopsy Could Identify Advanced Breast Cancer Patients novel blood test developed by scientists at the University of Leicester (Leicester, UK; www2.le.ac.uk) measures genetic changes in circulating cancer DNA that could help identify patients with metastatic breast cancer who could benefit from a change of treatment. David Guttery, PhD, a leading author of the study, said, “We have developed a novel blood test that can simultaneously detect somatic mutations and copy number alterations that are integral in driving the growth of breast cancer. By analyzing blood plasma to measure for cancer-specific changes to key breast cancer genes, including the HER2 and estrogen receptor genes, we hope this test could help doctors and patients choose the best treatment at the best time.” The study was described by Professor Jacqui A. Shaw, PhD, in an oral presentation at the Frank May Prize Lecture on June 26, 2017, at the University of Leicester.

Test Discriminates Between Viral and Bacterial Infections cientists at the University of Rochester School of Medicine (Rochester, NY, USA; www.urmc.rochester.edu) showed that RNAseq and qPCR confirmed significant differences in mean expression for 10 genes previously identified as discriminatory for bacterial LRTI. Ann R. Falsey, MD, a professor and the lead study author, said, “It’s extremely difficult to interpret what’s causing a respiratory tract infection, especially in very ill patients who come to the hospital with a high fever, cough, shortness of breath and other concerning symptoms. My goal is to develop a tool that physicians can use to rule out a bacterial infection with enough certainty that they are comfortable, and their patients are comfortable, foregoing an antibiotic.” The study was published on July 26, 2017, in the journal Scientific Reports.

New Test Rapidly Diagnoses Preeclampsia n international team of scientists collaborating with those at the Mayo Clinic, (Rochester, MN, USA; www.mayo.edu) concluded that their findings provide evidence that

AUGUST Clinical Mass Spectrometry Comes of Age: World's First Fully-Integrated Analyzer next-generation diagnostic system, brings together the convenience of clinical analyzers with the selectivity and sensitivity of liquid chromatography-tandem mass spectrometry (LC-MS/MS). The fully-automated Cascadion SM Clinical Analyzer system was developed by Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) for use by non-experts in a variety of clinical settings including hospital laboratories, and to provide results for a range of frequently ordered clinical diagnostic tests. The new Cascadion SM Clinical Analyzer (www.thermofisher.com/Cascadion) was presented to the European market at the EuroMedLab 2017 meeting last June in Athens, Greece, and unveiled to the US ciinical lab community at this year's AACC Clinical Lab Expo held in August at San Diego, CA. As a major benefit, the system can be operated by clinical laboratory staff without special training in LC-MS/MS technology.

Disposable POC Device to Serve Low-Resource Areas recent paper described a novel diagnostic device fabricated from various types of paper to be used for point-of-care testing in areas lacking electricity and other resources. The developers at Purdue University (West Lafayette, IN, USA; www.purdue.edu) used different types of paper to fabricate Self-powered, Paper-based Electrochemical Devices (SPEDs) that were designed for sensitive diagnostics in low-resource settings. SPEDs are inexpensive, lightweight, mechanically flexible, easy to use, and disposable by burning. “To our knowledge, this work reports the first self-powered, paper-based devices capable of performing rapid, accurate, and sensitive electrochemical assays in combination with a low-cost, portable potentiostat that can be recharged using a paper-based TEG,” said contributing author Dr. Ramses V. Martinez, assistant professor of industrial and biomedical engineering at Purdue University.

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Year’s Top 100 Clinical Developments Expanded Pathogen Identification Database Gets Clearance newly expanded database, now offers simple, rapid, safe and reliable identification of these medically important pathogens, providing clinicians with actionable results to better manage these infections, such as tuberculosis, lung and bone infections, and other serious organ infections. The database includes more than 15,000 distinct strains to provide extremely high accuracy and, for the first time, enables the safe identification of the Mycobacterium tuberculosis (TB) group, the most frequent non-tuberculous mycobacteria (NTM), Nocardia and the most medically important molds. The VITEK MS, Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) Mass Spectrometry System (bioMérieux, Marcy-l’Étoile, France; www. biomerieux.com) for rapid pathogen identification, has received 510(k) clearance from the US Food and Drug Administration (FDA, Silver Springs; MD, USA; www.fda.gov) for the expanded identification of mycobacteria, Nocardia and molds.

nually and that exhibits widespread antibiotic resistance. They captured bacterial cells directly from samples with low bacterial counts (104 colony forming units [cfu]/mL) using a custom-designed microfluidic chip and monitor their individual growth rates using microscopy. By averaging the growth rate response to an antibiotic over many individual cells, they can reduce the detection time to the biological response time of the bacteria. Özden Baltekin, a PhD student, who performed most of the laboratory work and is the first author of the study said, “We’ve developed a new method that allows determination of bacterial resistance patterns in urinary tract infections in 10 to 30 minutes. By comparison, the resistance determination currently in use requires one to two days.” The study

was published on August 8, 2017, in the journal Proceedings of the National Academy of Sciences.

Molecular Blood Test Developed for Kidney Cancer he mechanisms involved in renal cell carcinoma (RCC) development and progression remain unclear, and new biomarkers are needed in routine practice to improve the diagnostic and/or prognostic accuracy. A blood test for kidney cancer, which is under development by a team of scientists at the Jinling Hospital (Nanjing, China; www.nju.edu.cn), could improve screening for this disease and help ensure that asymptomatic patients are diagnosed while their cancer is still

Molecular Assay Identifies Colorectal Cancer n a previously published study, clinical data showed that the liquid biopsy test Colvera (Clinical Genomics, North Ryde, NSW, Australia; www.clinicalgenomics.com) detected twice the number of recurrence cases as carcinoembryonic antigen (CEA) testing, the current guidelines-recommended blood test used for CRC recurrence monitoring. As Colvera only requires a peripheral blood sample, the test can be administered along with other CRC surveillance tests, including CEA. Lawrence LaPointe, PhD, President and CEO of Clinical Genomics, said, “Colorectal cancer outcomes improve with early detection but currently available monitoring tests frequently fail to detect disease at a point when clinical intervention can be effective. This failure is a key reason why mortality from colorectal cancer is so high. Colvera is a new test that can detect molecular changes in circulating tumor DNA associated with cancer development. Colvera provides physicians with actionable information that can trigger further clinical assessment. The overall aim is to improve survival through early detection.”

New Ultrafast Method Determines Antibiotic Resistance cientists at Uppsala University (Sweden; www.uu.se) developed a point-of-care susceptibility test for urinary tract infection, a disease that 100 million women suffer from an-

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Annual Review 2016 treatable. Chunni Zhang, PhD, the lead author of the study, said, “Both miR-651 and miR-708 may potentially serve as novel biomarkers for renal cell carcinoma and may act as tumor suppressors. Our findings indicate that targeting miR-651 and miR708 by a genetic approach may provide a novel strategy for the treatment of renal cell carcinoma.” The study was presented at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo, held July 30 to August 3, in San Diego, CA, USA.

New Assay Facilitates Diagnosis of Rare Infant Disease novel flow cytometric assay that is easily performed in diagnostic laboratories was developed to improve the ability to diagnose the rare syndrome, hepatic veno-occlusive disease with immunodeficiency (VODI). To facilitate VODI diagnosis, investigators at the University of Basel (Switzerland; www.unibas.ch) developed a novel flow cytometric assay that is easily performed in diagnostic laboratories and might thus become a standard assay for the evaluation of patients who may have VODI. In addition, the assay will facilitate investigations directed at understanding the function of Sp110. “We expect that this test will soon be used in laboratories to diagnose a Sp110 deficiency,” said senior author Dr. Mike Recher, professor of biomedicine at the University of Basel. “The test will also help us quickly discover more about the biological function of Sp110.” The flow cytometry assay for diagnosis of VODI was described in the August 21, 2017, online edition of the Journal of Clinical Immunology.

Immunoassay May Simplify Screening for Liver Cancer research team, led Prof. Marc Porter and Prof. Courtney Scaife of University of Utah (Salt Lake City, UT, USA; www.utah.edu), developed a test for hepatocellular carcinoma that doesn’t involve sending a specimen to a blood lab and cuts the wait time for results from 2 weeks to 2 minutes. This inexpensive test can be administered wherever the patient is, which would be particularly valuable in developing nations with little access to hospitals. “The concept is similar to a home pregnancy test, but instead of flowing laterally, it flows through the membrane,” said paper firstauthor Jennifer Granger, research associate at U. Utah. The idea for the test is a spinoff of a similar test Prof. Porter developed years ago that astronauts on the International Space Station used to test the cleanliness of their drinking water. “This is a smarter offshoot of that,” said Prof. Porter. The study, by Granger JH et al, was published August 9, 2017, in the journal of Analytical Methods.

Artificial Intelligence Could Help Identify Early Skin Cancer ewly developed technology uses artificial intelligence (AI) to help detect melanoma skin cancer earlier than current methods and to help reduce the number of unnecessary biopsies. The AI-based method employs machine-learning software to analyze images of skin lesions and to provide doctors with objective data on telltale bio-

Year’s Top 100 Clinical Developments markers of melanoma. “This could be a very powerful tool for skin cancer clinical decision support,” said Alexander Wong, professor at University of Waterloo (Waterloo, ON, Canada; https://uwaterloo.ca), “The more interpretable information there is, the better the decisions are.” Prof. Wong developed the technology in collaboration with Daniel Cho, former PhD student at Waterloo, David Clausi, professor at Waterloo, and Farzad Khalvati, adjunct professor at Waterloo and scientist at Sunnybrook. The research was recently presented at the 14th International Conference on Image Analysis and Recognition (ICIAR 2017, July 5-7, 2017, Montreal, Canada).

Molecular Blood Test Could Diagnose Ischemic Stroke cientists at Ochsner Medical Center (New Orleans, LA, USA; www.ochsner.org) and their colleagues compared blood levels of non-coding ribonucleic acids (RNAs), molecules that regulate gene expression, in patients who had a stroke within five days to those who either had not had a stroke or had a stroke more than five days prior. The authors concluded that serum circR-284: miR-221 has potential as a diagnostic biomarker of carotid plaque rupture and stroke. Moreover, they demonstrated the use of functionally related pairs of circulating noncoding RNAs as biomarkers in cardiovascular disease. Hernan A. Bazan, MD, an assistant professor of surgery and lead author of the study, said, “This work represents an important step towards understanding and predicting carotidrelated strokes. Through ongoing translational studies such as this, we are aiming to develop better treatments and work towards preventing these episodes.” The study was published on August 4, 2017, in the journal Circulation: Cardiovascular Genetics.

bad, CA, USA; www.autogenomics.com), an automated multiplexed film-based microarray assay that can simultaneously detect H. pylori and its resistance to clarithromycin from human biopsy samples in a clinic setting. The results showed that, the Hpylori-Q assay detected 48 out of the 50 H. pylori positive DNA specimens (96% sensitivity) and identified the entire 50 negative DNA as negative for H. pylori (100% specificity). In addition, 17 out of the 50 positive specimens were tested as clarithromycin resistant (34%), while nine had an A2142G point mutation, another nine DNA carried A2143G point mutation and one carried both A2142G, and A2143G mutations. The study was presented at the 69th AACC Annual Scientific Meeting and Clinical Expo held July 30 to August 3, 2017, in San Diego, CA, USA.

Smartphone-Based ELISA Developed for Blood Antigens novel high speed, lab-on-a-chip ELISA test for antigens in blood samples depends on a unique nonstick polymer coating that eliminates the need for multiple incubation and washing steps. Investigators at Duke University (Durham, NC, USA; www.duke.edu) used an inkjet printer to spray an array of antibodies onto glass slides treated with a unique nonstick polymer brush coating. The coating functioned like Teflon to prevent non-target proteins from attaching to the surface of the slide and causing high levels of background “noise”. “The real significance of the assay is the polymer brush coating,” said senior author Dr. Ashutosh Chilkoti, professor of biomedical engineering at Duke University. “The polymer brush allowed us to store all of the tools we need on the chip while maintaining a simple design.” The D4 system was discussed in detail in the August 7, 2017, online edition of the Proceedings of the [U.S.] National Academy of Sciences.

Novel PCR Test Detects H. Pylori Drug Resistance

cientists have evaluated a molecular based diagnostic test for H. pylori called the Hpylori-Q Assay (Autogenomics, Inc., Carls-

SEPTEMBER Simple Blood Test Could Replace Biopsies in Lung Cancer Diagnosis he Cobas EGFR Mutation Test v2 CE-IVD (Roche Molecular Diagnostics, Pleasanton, CA, USA; https://molecular.roche.com) identifies the epidermal growth factor receptor (EGFR) gene in the DNA from non-small cell lung cancer (NSCLC) patients and is intended for use as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI). This innovative assay is the first to utilize plasma in addition to tissue as a sample type, thus removing common barriers to molecular testing, including surgery risks and sample availability. With clear, actionable results, the test gives clinicians the information needed to make confident treatment decisions. Phillipe Taniere, MD, PhD, a Consultant Histopathologist at UHB, said, “Identifying mutations in blood samples has historically been a challenge due to the low frequency of cancerous cells in the sample. However this new, powerful technology from Roche Diagnostics has made it possible to take a simple blood sample and rapidly identify EGFR mutations in tumors’ DNA.”

New Assay Improves Detection of Tuberculosis cientists at the Rutgers New Jersey Medical School (Newark, NJ, USA; www. njms.rutgers.edu) and their many colleagues developed the Xpert MTB/RIF Ultra assay (Ultra) to improve performance of the G4 cartridge used in Xpert (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). Ultra and Xpert limits of detection (LOD), dynamic ranges, and RIF-R rpoB mutation detection were tested on Mycobacterium tuberculosis DNA or sputum samples spiked with known numbers of M. tuberculosis H37Rv or M. bovis BCG CFU. Frozen and prospectively collected clinical samples from patients suspected of having TB, with and without culture-confirmed TB, were also tested. The authors conclude that that Ultra will result in greater TB case detection rates not only in subjects with paucibacillary TB, such as those with human immunodeficiency virus (HIV) coinfection, but also in pediatric patients with TB and those with extrapulmonary TB, which are

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Annual Review 2016 known to have lower mycobacterial loads. The study was published on August 29, 2017, in the journal mBio.

Early Stage Melanoma Identified by Simple Blood Test cientists at the Edith Cowan University (ECU, Perth, Australia; www.ecu.edu.au) have developed blood-based biomarkers for early diagnosis, prognosis and personalization of treatment in melanoma. Through the implementation of cutting-edge technologies and next generation sequencing the team scrutinized novel biomarkers such as Circulating Tumor Cells (CTCs) and Circulating Tumor DNA (ctDNA). In addition, they expanded the study of miRNA, exosomes and autoantibodies for improved specificity and sensitivity. The technologies are now being expanded to include prostate, breast and lung cancers. The team is also monitoring the DNA of patients who finish treatment to see if they remain disease-free. The study was presented a meeting titled “Melanoma research and therapy in New Zealand: Raising the bar through collaborative action” held on September 9, 2017, in Queenstown, New Zealand and organized by Melanoma New Zealand.

Liquid Biopsy Test Launched For NRAS Mutations he new Target Selector NRAS mutation test is provided by Biocept, Inc (San Diego, CA, USA; www.biocept.com) and uses the Company’s proprietary switch blocker technology, which enriches for oncogene mutations of interest and results in highly sensitive biomarker detection. The Company’s liquid biopsy tests are performed in its CLIA-certified, CAP-accredited laboratory. Biocept now offers 15 CLIA-certified liquid biopsy tests utilizing its Target Selector platform to determine the status of key cancer biomarkers listed in the National Comprehensive Cancer Network (NCCN) Guidelines (Fort Washington, PA, USA; www. nccn.org). Lyle Arnold, PhD, Biocept’s Chief Scientific Officer, said, “Our newest assay combines our proprietary switch blocker technology for improved mutation detection with the power of next generation sequencing, resulting in ultra-high sensitive performance of our liquid biopsy NRAS test. This is our first commercially available assay that utilizes more than one switch blocker in the assay to interrogate multiple genes simultaneously, demonstrating our ability to develop multiplex panels that can analyze several different mutated gene regions in a single test.”

Genetic Test Discovered for Predicting Cancer Recurrence ollaborating scientists at the University of Salford (Greater Manchester, UK; www. salford.ac.uk) and the University of Calabria (Cosenza, Italy; www.unical.it) identified new measures by looking at the expression levels of mitochondrial genes in samples from post-treatment cancer patients. The team used multiple KaplanMeier curves to extrapolate how mitochondrial gene levels correlated with recurrence in hundreds of cancer patients. Certain genes predicted up to

Year’s Top 100 Clinical Developments five times higher rates of recurrence or metastasis. One particularly useful biomarker, namely Heat Shock Protein Family D (Hsp60) Member 1(HSPD1), is associated with mitochondrial biogenesis, the process of making of new mitochondria. Federica Sotgia, PhD, the lead investigator of the study, said, “In practical terms, a person in remission could be predicted to be 80% likely to fail treatment. If doctors can predict that a treatment will likely fail, it gives them more positive options; either they can monitor the patient more closely or offer an alternative course of treatment.” The study was published on July 27, 2017, in the journal Oncotarget.

OCTOBER Blood Test Predicts Patient Response to Immunotherapy n a first-of-its-kind study in the field, researchers found that testing blood-based liquid biopsy samples for genomic mutations in circulating tumor DNA (ctDNA) could help reveal which patients would likely respond to checkpoint inhibitor-based immunotherapies (CIIs). “We can help predict response to immunotherapy by measuring the number of mutations in ctDNA using a simple blood test,” said first-author Yulian Khagi, MD, of University of California San Diego School of Medicine (San Diego, CA, USA; https://healthsciences.ucsd.edu), “Immunotherapy can result in serious side effects, and therefore being able to predict who will respond is important to mitigating potential risk to each patient.” The study’s findings on blood biopsy samples mirror what has been previously described in genomic testing of tissue biopsy samples. The blood-based liquid biopsy can be used as a relatively noninvasive diagnostic tool to detect onset of disease, monitor its progression, and measure its retreat. The study, by Khagi Y et al, was published October 1, 2017, in the journal Clinical Cancer Research.

Pre-Op Test Can Detect Some Pancreatic Cancers newly developed genetic test is highly sensitive at determining which pancreatic cysts are most likely to be associated with one of the most aggressive types of pancreatic cancer. The successful results are a critical step toward a precision medicine approach to detecting and treating pancreatic cancer. “You never want to subject a patient to unneeded surgery,” said lead author Aatur D. Singhi, MD, PhD, a surgical pathologist at University of Pittsburgh Medical Center Health System (UPMC; Pittsburgh, PA, USA; www.upmc.com/Pages/default.aspx), “This rapid, sensitive test will be useful in guiding physicians on which patients would most benefit from surgery.” Marina N. Nikiforova, MD, of UPMC is the study’s senior author. The team developed PancreaSeq, which requires a small amount of fluid removed from the cyst to test for 10 different tumor genes associated with pancreatic cancer. It was a first-in-thefield prospective study testing pancreatic cysts before surgery rather than analyzing cysts after surgery as had been done by previous efforts. The Pan-

creaSeq test currently is available to patients and ordered through UPMC. The study, by Singhi AD et al, was published September 28, 2017, in the journal Gut.

Rapid Diagnostic Used in Sepsis Management new diagnostic test will identify directly, without the need for culture, the microbial cause of bloodstream infection leading to sepsis. Fast and accurate identification of the infection can be a lifesaver. The test achieves this relatively quickly compared to at least a day for current tests that rely on a prior positive blood culture. LiDia (DNA Electronics Ltd, Carlsbad, CA, USA; www.dnae.com) is a closed system that can be operated at the clinical point-of-need, with no laboratory services or specialist training required. It is able to deliver accurate results in less than three hours, direct from blood (or other sample material), providing treating physicians with valuable intelligence to help treat their patients. The genomic analysis platform, LiDia, is based on the invention of semiconductor DNA sequencing by serial technology. The product was introduced at the BioCentury’s 24th Annual Newsmakers in the Biotech Industry meeting held September 8, 2017, in New York, NY, USA.

Next-Generation Immunoassay Developed for Chagas Diseases hagas disease, caused by the protozoan Trypanosoma cruzi, is a major health and economic problem in Latin America for which no vaccine or appropriate drugs for largescale public health interventions are yet available. Medical Parasitologists at the National University of General San Martín (Buenos Aires, Argentina; www.unsam.edu.ar) developed a novel, robust multi-epitope formulation as a basis for improved peptide-based serodiagnosis for chagas disease. In contrast with chimeric DNA constructs that encode multiepitope recombinant proteins, the fact that this diagnostic reagent is based on the combination of short peptides that can be synthesized separately and easily formulated in a mix-andmatch approach, means that it can be improved successively over time with only a reasonable effort. The study was published on October 9, 2017, in the journal Public Library of Science Neglected Tropical Diseases.

NOVEMBER Assay Identifies Patients Benefiting from Cancer Immunotherapies rogrammed cell death ligand 1 (PD-L1) has been detected in up to 50% of all human cancers, and has become a major focus of therapeutic and biomarker studies. A team of scientists collaborating with those at Pinehurst Medical Clinic-East (Pinehurst, NC, USA; www. pinehurstmedical.com) focused this test development on mechanisms of blood-based testing for sensitive measurement of circulating RNA using

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Annual Review 2016 droplet digital polymerase chain reaction (ddPCR). The authors concluded that they have developed sensitive and specific methods that measure the dynamic range of PD-L1 in circulation. The study was presented on October 28, 2017, at the AACR-NCIEORTC conference held in Philadelphia, PA, USA.

New Methods Developed to Diagnose TB and HIV cientists at Arizona State University (Tempe, AZ, USA; www.asu.edu) applied nanotechnology-based approaches to detect TB proteins in patient blood samples to improve disease detection. Unlike existing methods that attempt to identify bacteria or bacterial DNA in sputum or tissue samples, their two methods measure TB-derived factors released into the blood only during active TB infections and provide a measure of the number of active TB bacteria in the patient. The authors concluded that their study indicated that serum CFP-10 measurement can greatly improve TB diagnosis rates in HIV/TB-co-infected patients, who are diagnosed with reduced efficiency by current TB diagnostics. Improved TB diagnosis is a major unmet need for HIV-infected patients, as undiagnosed and untreated TB is a major cause of excess morbidity and mortality. The study was published on November 1, 2017, in the journal BMC Medicine.

Prenatal Reflex DNA Screens For Three Trisomies edical scientists at Queen Mary University of London (QMUL, UK; www.qmul.ac.uk) have demonstrated that it is possible to incorporate DNA analysis into antenatal screening for three serious chromosome disorders, including Down’s syndrome, in a way that is far more accurate than existing methods, and safer and less stressful for mothers. The new method, called antenatal “reflex DNA screening,” which screens for Down’s syndrome, Edwards syndrome and Patau syndrome, detected more affected pregnancies than the test it replaced, with far fewer false-positives. Reflex DNA screening combines conventional screening with new DNA testing. The study was published on November 9, 2017, in the journal Genetics in Medicine.

High-Value Practice Reduces Wasteful Blood Transfusions

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xperts at the Johns Hopkins Medical Institutions (Baltimore, MD, USA; www. hopkinsmedicine.org) and their colleagues I

analyzed data from randomized clinical trials comparing blood transfusion approaches and endorse recommendations for blood transfusions that reduce blood use to improve patient safety and outcomes. Steven M. Frank, MD, professor of anesthesiology and the lead investigator, said, “In summary, there is no benefit in transfusing more blood than necessary and some clinical trials actually show harm to patients. All this does is increase risks and cost without adding benefit.” The study was published on November 20, 2017, in the journal JAMA Internal Medicine.

Blood Biomarker Detected For Different Diseases iomedical engineers at Purdue University (Lafayette, IN, USA; www.purdue.edu) developed a test that can detect minute amounts of proteins, including protein from glial cells, which surround neurons in the brain. The proteins are secreted in relatively high concentrations in cerebrospinal fluid of victims of traumatic brain injury. Prior studies have found that a small amount of fluid leaked through the blood-brain barrier and got into the bloodstream of victims. Eric A. Nauman, PhD, a professor in the School of Mechanical Engineering and a co-author of the study, said, “There’s a whole host of diseases and different conditions where, if you could find these things in small quantities early on and just make it part of a standard workup, you could decrease health-care costs greatly. The study was published on November 1, 2017, in the journal IEEE Sensors.

Dipstick Technology Could Revolutionize Disease Diagnosis cientists at the University of Queensland (St. Lucia, Australia; www.uq.edu.au) investigated a variety of materials for their suitability for nucleic acid capture and purification. The team found that untreated cellulose-based paper can rapidly capture nucleic acids within seconds and retain them during a single washing step, while contaminants present in complex biological samples are quickly removed. Building on this knowledge, they have successfully created an equipment-free nucleic acid extraction dipstick methodology that can obtain amplification-ready DNA and RNA from plants, animals, and microbes from difficult biological samples such as blood in less than 30 seconds. The study was published on November 21, 2017, in the journal Public Library of Science Biology.

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Genetic Link Found Between Immune System and Lymphoma group of scientists at the Institute of Cancer Research (London, UK; www.icr.ac.uk) identified six new single-letter changes in DNA that were linked to the development of Hodgkin lymphoma and five of these affect the way a type of white blood cell, called B cells, develop. Richard S. Houlston, FMedSci, FRS, senior author of the study, said, “Our study links the risk of dis-

ease to changes in the genes that control how B cells develop. Interestingly, we found that some of the genetic changes we have linked to Hodgkin lymphoma have previously been associated with the risk of autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. The new information could point towards new ways of diagnosing, treating, or even helping prevent Hodgkin lymphoma.” The study was published on December 1, 2017, in the journal Nature Communications.

Rapid POC Assay Detects Micronutrient Deficiencies nvestigators at Cornell University (Ithaca, NY, USA; www.cornell.edu) developed a rapid diagnostic test and mobile enabled platform for simultaneously quantifying iron (ferritin), vitamin A (retinol-binding protein), and inflammation (C-reactive protein) status. The method combines multiple florescent markers and immunoassay approaches in a single test, allowing accurate quantification in 15 minutes even though the physiological range of the markers of interest vary over five orders of magnitude. The system was described in the December 4, 2017, online edition of the journal Proceedings of the [U.S.] National Academy of Sciences.

MUSE Microscopy Emerges as Diagnostics Tool cientists at University of California Davis Medical Center (Sacramento, CA, USA; www.ucdmc.ucdavis.edu) developed a simple, non-destructive slide-free technique that, within minutes, provides high-resolution diagnostic histological images resembling those obtained from conventional hematoxylin and eosin histology. The approach, which they named Microscopy with Ultraviolet Surface Excitation (MUSE), can also generate shape and color-contrast information. MUSE relies on ~280 nm ultraviolet light to restrict the excitation of conventional fluorescent stains to tissue surfaces and it has no significant effects on downstream molecular assays (including fluorescence in situ hybridization and RNA sequencing). The study was published on December 4, 2017, in the journal Nature Biomedical Engineering.

Earlier Disease Detection with Aptamer-Related Blood Test novel, highly sensitive blood test for a wide range of serum proteins combines aptamer-DNA capture molecules with nanopore-based single molecule sensing. Dr. Alex Ivanov, research fellow in the department of chemistry at Imperial College London, said, “The detection of single molecules of biomarkers represents the ultimate in sensitivity for early diagnosis. We have now shown that this is possible to perform such measurements in real human samples, opening up the potential for meaningful early diagnosis.” The aptamer-based nanopore analytical method was described in the November 16, 2017, online edition of the journal Nature Communications.

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Year’s Top 100 Clinical Developments Molecular Automation Changing Clinical Laboratories ost mid-career laboratory medicine professionals find it hard not to recall the days when DNA had to be extracted manually and polyacrylamide gels were mixed by hand without also reflecting on how fast things have changed. Automation has come so far, in fact, that it is poised to disrupt the very structure of molecular diagnostics laboratories. New molecular automation systems are capable of connecting directly to clinical chemistry and immunoassay lines, potentially moving high-volume testing out of molecular diagnostics entirely. A study on the subject was published on December 1, 2017, in Clinical Laboratory News.

Smartphone Case Offers Glucose Monitoring Regardless of Location ioengineers at the University of California - San Diego (La Jolla, CA, USA; http://jacobsschool. ucsd.edu) have developed a glucose meter that includes a custom-built smartphone case that houses a permanent bare sensor strip, a stylus that is loaded with enzyme-carbon composite pellets, and sensor instrumentation circuits. A custom-designed Android-based software application was developed to enable easy and clear display of measured glucose concentration. A study on the subject was published online on October 17, 2017, by the journal Biosensors and Bioelectronics.

Microscope-Based AI Identifies Bacteria Accurately icroscopes enhanced with artificial intelligence (AI) could help clinical microbiologists diagnose potentially deadly blood infections and improve patients’ odds of survival. Scientists have demonstrated that an automated AI-enhanced microscope system is “highly adept” at identifying images of bacteria quickly and accurately. The automated system could help alleviate the current lack of highly trained microbiologists, expected to worsen as 20% of technologists reach retirement age in the next five years. A study on the subject was published on November 29, 2017, in the Journal of Clinical Microbiology.

Cartridge Diagnoses Antibiotic-Resistant Bacteria diagnostic platform that exploits the phenomenon of linear dichroism (LD) for a number of uses including the detection of antibiotic resistance in infections was developed by Linear Diagnostics Ltd (Birmingham, UK; www.lineardiagnostics.com), a spin-off from the University of Birmingham (Birmingham, UK; www.birmingham.ac.uk). The

LabMedica International December/2017-January/2018

technology is based on the arrangement of long, thin nanometer-sized molecules in a microfluidic chamber inside a test cartridge, which is self-contained, sterile, and holds all the reagents needed to perform a test. Scientists use a handheld external optical reader, to detect the molecules’ alignment in the chamber by shining polarized light from different angles into the cartridge.

Nanowire Technology Detects Cancer Biomarkers in Urine new approach for detecting cancer biomarkers in urine has been developed using a device composed of nanowires anchored into a microfluidic substrate. This device enables

Annual Review 2016 EV collections at high efficiency and in situ extractions of various microRNAs (miRNAs) of different sequences (around 1,000 types) that significantly exceed the number of species being extracted by the conventional ultracentrifugation method. Takao Yasui, PhD, corresponding author of the study at Nagoya University (Furo-cho Japan; http:// nagoya-u.ac.jp), said, “Our device could allow us to collect thousands of urinary microRNAs from only 1 mL of urine and should allow scientists to move closer to the long-term goal of urinary miRNAbased early diagnoses with timely medical checkups for a variety of cancers.” The study was published on December 15, 2017, in the journal Science Advances.

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PerkinElmer Acquires Indian IVD Concern

Qiagen Buys US Bioinformatics Firm

erkinElmer, Inc. Waltham, MA; USA; (www.perkinelmer.com), acquired Tulip Diagnostics Private Ltd., (Goa, India; www. tulipgroup.com), one of India’s largest domestic providers of in-vitro diagnostic reagents, kits and instruments. Tulip’s solutions include products for the prevention, screening and diagnosis of infectious diseases such as malaria, HIV and hepatitis, and it has two manufacturing facilities located in India. “In-vitro diagnostics is one of the fastest growing vertical segments in India, and Tulip provides the key enablers for PerkinElmer to broaden our infectious disease screening menu and capabilities for customers throughout the region,” said Jayashree Thacker, President, PerkinElmer India.

IAGEN N.V. (Hilden, Germany; www. qiagen.com) has acquired OmicSoft Corporation (Cary, NC, USA; www.omicsoft.com), which focuses on biomarker data management, visualization, and analysis. OmicSoft designs and develops bioinformatics, next generation sequencing, and cancer genomics software for biomarker data management, visualization, and analysis. Its suite of software solutions enable scientists and researchers to efficiently analyze and visualize their own data sets and compare them to massive volumes of publicly available ‘omics’ data sets, and share the results with colleagues. The acquisition will provide QIAGEN access to OmicSoft’s multi-omics data management infrastructure solution as well as curated ‘omics’ data sets that complement its bioinformatics portfolio for gaining insights into complex biological data.

Instrumentation Laboratory Acquires Accriva Diagnostics nstrumentation Laboratory (IL) (Bedford, MA, USA; www.instrumentationlaboratory. com), a subsidiary of Werfen (Barcelona, Spain; www.werfen.com), acquired Accriva Diagnostics (San Diego, CA, USA; www.accriva.com), which provides in vitro diagnostic (IVD) blood testing at the Point-of-Care (POC). The acquisition of Accriva, whose product portfolio includes coagulation, platelet aggregation, CO-Oximetry, and incision devices, is expected to allow IL to further enhance its position in hospital-based POC hemostasis testing, POC critical care testing, and the hemostasis laboratory segment.

Agilent Technologies Acquires Belgian Molecular Diagnostic Kits Producer gilent Technologies Inc. (Santa Clara, CA, USA; www.agilent.com) acquired European diagnostics company Multiplicom N.V. (Niel, Belgium; www.multiplicom.com), for approximately EUR 68 million in cash. Multiplicom develops, manufactures and commercializes molecular-diagnostic solutions, provided as kits. These solutions enable clinical laboratories to identify the DNA variants that are associated with a genetic disease or predisposition in patients, or that may steer cancer therapy or identify congenital defects early in pregnancy. "The acquisition of Multiplicom significantly strengthens our presence in the genomics market," said Herman Verrelst, vice president and general manager of Agilent's Genomics Division. "Multiplicom's products and technology help expand our target-enrichment portfolio and enhance our next-generation sequencing workflow capabilities – providing immediate scale in adjacent markets.”

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Greiner Bio-One Acquires its Distributors in Iberian Peninsula reiner Bio-One (Kremsmünster, Austria; www.gbo.com) has acquired its long-standing distribution partners, Vacuette España and Vacuette Portugal, which will now allow the company to serve its customers in Spain and Portugal directly through its own distribution subsidiaries. For over 20 years, the Greiner Group has worked with Vacuette España and Vacuette Portugal, both of which served as exclusive distributors for Greiner Bio-One International on the Iberian Peninsula. The two subsidiaries based in Madrid and Porto will now continue to supply directly to their customers in both markets.

PerkinElmer Acquires EUROIMMUN erkinElmer, Inc. (Waltham, MA, USA; www.perkinelmer.com), acquired EUROIMMUN Medical Laboratory Diagnostics AG (Lübeck, Germany; www.euroimmun. com), which produces test systems and automation solutions for medical laboratory diagnostics. EUROIMMUN specializes in autoimmune testing, and infectious disease and allergy testing, with extensive expertise and capabilities across immunology, cell biology, histology, biochemistry and molecular biology. The acquisition of EUROIMMUN is expected to expand PerkinElmer's reach into autoimmune and allergy diagnostic markets, while offering new infectious disease capabilities to customers in China.

DIAsource Acquisition Expands Range of Endocrinology Offerings IAsource ImmunoAssays SA (Louvain-LaNeuve, Belgium; www.diasource-diagnostics. com), acquired Viro-Immun Diagnostics GmbH (Viro-Immun Diagnostics GmbH; www. viro-immun.eu), a developer and manufacturer of laboratory diagnostics for the medical diagnosis of

infectious and autoimmune diseases. With this transaction, DIAsource acquired the Viro-Immun brand name and all ELISA and IFA products, as well as full inventory and infrastructure, thereby further strengthening and extending its portfolio of endocrinology and Vitamin D products. The acquisition of Viro-Immun fits in with DIAsource's strategy to act as a consolidator in its core business of manual kits and open automation.

Siemens Acquires Blood Gas Subsidiary of Alere iemens Healthineers (Erlangen, Germany; www.healthcare.siemens.com), the separately managed healthcare business of Siemens AG, acquired Epocal Inc., a subsidiary of Alere Inc. (Waltham, MA, USA; www.alere.com) and a provider of point-of-care (POC) blood diagnostic systems for healthcare enterprises. Epocal’s portfolio of POC blood diagnostic systems includes the epoc Blood Analysis System, a handheld, wireless testing solution that provides blood gas, electrolyte and metabolite results near the patient in approximately 30 seconds after sample introduction. With a complete offering for blood gas diagnostics from a low-volume, single-use handheld device up to a high-volume, multi-use benchtop solution, Siemens aims to help customers improve their workflows and utilize the correct system for the needs of their particular settings.

Quidel Buys Alere’s Triage Business uidel Corporation (San Diego, CA, USA; www.quidel.com), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, acquired the Triage MeterPro cardiovascular (CV) and toxicology assets (“Triage business”) and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers (“BNP business”) from Alere Inc. (Waltham, MA, USA; www.alere.com). The products were being divested by Alere in order to obtain antitrust approvals required for its acquisition by Abbott. Quidel acquired the Triage business, including real estate for the San Diego Triage facilities, and the BNP business for a total consideration of USD 400 million in addition to USD 40 million in contingent consideration. Quidel will distribute the Triage MeterPro products and BNP assays through a combination of direct sales force and distributors.

DiaSorin Acquires Siemens' ELISA Immunodiagnostics Business iaSorin S.p.A. (Saluggia, Italy; www. diasorin.com) acquired Siemens Healthineers’ (Erlangen, Germany; www.healthcare. siemens.com) micro-titre-based ELISA immunodiagnostic business portfolio and related tangible and intangible assets, including customer sales and distribution contracts, installed base of instruments and relevant intellectual property. The acquisition was on a debt-free and cash-free basis for a total consideration of up to Euro 47.5 million. Siemens will continue to manufacture and provide its ELISA immunodiagnostic reagent kits exclusively to DiaSorin for up to three years, enabling continuous supply of its current ELISA immunodiagnostic products to customers.

LabMedica International December/2017-January/2018

ALPHABETICAL LISTING OF COMPANIES

77 Elektronika Hungary • Budapest Tel: (36) 1-206-1480 Web: e77.hu E-mail: sales@e77.hu Develops, manufactures, and markets fully automated and semi-automated urine analyzers, blood glucose meters, rapid test readers and their consumables under own brand name, as well as OEM and ODM products for market-leading multinational companies.

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AADEE

Abaxis USA • Union City, CA Tel: (1) 510-675-6500 Web: abaxis.com E-mail: abaxis@abaxis.com Produces point-of-care blood analyzers for both humans and animals. The analyzers are designed to be portable, require minimal training, provide onthe-spot results and offer builtin quality control and calibration. Abaxis markets the system under the name Piccolo in the human medical market and under the name VetScan in the veterinary market.

Abbott Diagnostics USA • Abbott Park, IL Tel: (1) 224-667-6100 Web: abbott.com Provides in vitro diagnostics, instrument systems, and tests. Products offer diagnostic solutions in immunochemistry, hematology, automation, molecular and remote diagnostics.

Abingdon Health UK • York Tel: (44) 1904-406-060 Web: abingdonhealth.com E-mail: info@abingdonhealth.com Develops and manufactures POC immunoassay tests, with specific focus on rapid tests for hematology oncology and B cell dyscrasias. The company also provides assay development and manufacturing services for customers looking to transfer lab-based assays to lateral flow assays.

AccuBio Tech China • Beijing Tel: (86) 10-6205-8220 Web: accubiotech.com E-mail: sales@accubiotech.com Develops and manufactures in

Accumax Lab Technology India • Kalol, Gujarat Tel: (91) 2674-248241 Web: accumaximum.com E-mail: info@accumaximum.com Manufactures micropipettes and accessories for use in clinical, research and industrial laboratories under the brand name Accumax. The range of Accumax products include digital variablevolume and fixed-volume micropipettes, minipipettes, spares, and micropipette stand.

Acon Laboratories USA • San Diego, CA Tel: (1) 858-875-8000 Web: aconlabs.com E-mail: info@aconlabs.com Provides rapid diagnostic products. The product line includes items for fertility, urine drugs of abuse, multidrug tests, oral fluid drugs of abuse, cotinine, urine adulteration, infectious disease, cardiac, and tumor markers. Recently added products include a blood glucose monitoring system, urinalysis reagent strips, thermometers, and blood pressure monitors.

Adaltis Italy • Rome Tel: (39) 0774-5791 Web: adaltis.net E-mail: info@adaltis.net Develops, manufactures, and markets in vitro diagnostic systems and reagent products to detect viral infections, diagnose immune system diseases, and measure human hormone responses.

Adam Equipment UK • Milton Keynes, Buckinghamshire Tel: (44) 1908-274-545 Web: adamequipment.com E-mail: sales@adamequipment.co.uk Manufactures and distributes a complete range of balances and scales for medical, laboratory, education, and industrial markets.

Advanced Biotechnologies USA • Columbia, MD Tel: (1) 410-792-9779 Web: abionline.com Specializes in the manufacture and development of products and services for the research, diagnosis, monitoring, and treatment of viral infectious diseases.

Advanced Instruments USA • Norwood, MA Tel: (1) 781-320-9000 Web: aicompanies.com E-mail:

WORLD’S IN VITRO DIAGNOSTICS COMPANIES info@aicompanies.com Supplies instrumentation for clinical, pharmaceutical, biotechnology, microbiology, and food laboratories. Primarily known for the application of freezing-point depression technology, current products have expanded to also include cytology, infrared, and image analysis.

Aeon Technology China • Shenzhen Tel: (86) 755-8618-2140 Web: aeon-med.com E-mail: raymond@aeon-med.com Designs and produces clinical diagnostic equipment, as well as containers and disposables.

Alere

the research projects and the needs of the academic and industrial sectors.

Agappe Diagnostics Switzerland Switzerland • Cham Tel: (41) 41-780-60-10 Web: agappeswiss.com E-mail: info@agappeswiss.com Manufactures products and immunoturbidimetry reagents for clinical chemistry, serology, serum protein, coagulation, and HbA1c analyzer.

ALCOR Scientific USA • Smithfield, RI Tel: (1) 401-737-3774 Web: alcorscientific.com E-mail: info@alcorscientific.com Manufactures, markets, and distributes clinical laboratory instrumentation such as the iSED for ESR testing.

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Argentina • Buenos Aires Tel: (54) 11 45234848 Web: aadee.com Manufactures, exports/imports medicine and biochemistry items. Products include the Automatic pH Blood Gas Analyzer, the AADEE-ZEN model and a fully automatic selective ION analyzer “AADEE-ZEN” ISE that has the capability to measure Na, K, Cl, and Ca.

vitro rapid diagnostic tests. Products include tests for pregnancy, infectious diseases, sexually transmitted diseases, fecal occult blood, tumor markers, drugs of abuse, blood glucose, and urine reagent strips.

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USA • Waltham, MA Tel: (44) 1234-759900 Web: alere.com Develops rapid point-of-care diagnostics that focus on infectious disease, cardiology, oncology, drugs of abuse, and women's health.

AirClean Systems USA • Raleigh, NC Tel: (1) 919-255-3220 Web: aircleansystems.com E-mail: contact@ aircleansystems.com

AESKU Diagnostics Germany • Wendelsheim Tel: (49) 6734-9622-0 Web: aesku.com E-mail: info@aesku.com Distributes ELISA kits for diagnostics of autoimmune diseases, including the AESKULISA product line. The main indications are rheumatology, antiphospholipid syndrome (APS), vasculitis, gastroenterology, hepatology, and diabetes.

Aferrix Israel • Tel Aviv Tel: (972) 72-2126144 Web: aferrix.com E-mail: info@aferrix.com Develops, manufactures, and markets fluorescence-based kits for the diagnosis and monitoring of iron overload. The company also provides testing services for pharmaceutical companies and research centers worldwide.

Affinity Biologicals Canada • Ancaster, ON Tel: (1) 905-304-9896 Web: affinitybiologicals.com E-mail: info@ affinitybiologicals.com Manufactures antibodies, purified proteins, control plasmas, calibrator plasmas, ELISA kits, and factor-deficient plasmas prepared by immunoaffinity chromatography.

Agro-Bio A Stago Company France • La Ferté Saint-Aubin Tel: (33) 238-648-350 Web: agro-bio.com E-mail: stephanie.harvel@ agro-bio.com Specializes in biotechnological solutions and high quality products for immunotechnology, protein biochemistry, and platelet aggregation to serve

Although all material in this directory is compiled from sources believed reliable, publisher cannot be held liable for any errors, omissions or inaccuracies. Inclusion, or lack of it, in this directory, does not constitute any endorsement or expression of other opinion by publisher with regard to companies, their products or services.

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LabMedica 300 Specializes in diagnostics, and offers the biotechnology field a diagnostic as well as a medical line, along with laboratory equipment and disposables.

Alfa Scientific Designs

UK • Hampshire Tel: (44) 23-8048-7209 Web: alphalabs.co.uk E-mail: export@alphalabs.co.uk Specializes in supplying lab products such as pipettes and liquid handling systems, as well as containers, disposables, and specimen transport packaging.

USA • Poway, CA Tel: (1) 858-513-3888 Web: alfascientific.com E-mail: info@alfascientific.com Develops and manufactures rapid in vitro diagnostic devices to serve the point-of-care marketplace. The company focuses on rapid immunoassays including those for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac and cancer markers.

Alifax Italy • Padua Tel: (39) 49-099-2000 Web: alifax.com E-mail: info@alifax.com

Alpha Laboratories

AMEDA Labordiagnostik Austria • Graz Tel: (43) 316-698069 Web: amp-med.com E-mail: office.graz@ampmed.com Offers a range of products known under the AMP Diagnostics brand, including kits

and equipment for clinical chemistry, immunology, hematology and coagulation, as well as urine and rapid diagnostics.

diseases, tumors, allergies, drugs of abuse, heart, kidney, and liver functions.

American Biochemical & Pharmaceuticals

Italy • Rome Tel: (39) 0774-354441 Web: amsalliance.com E-mail: info.it@amsalliance.com Develops, manufactures and markets instrumentation, reagents and tests for medical diagnostics, and focuses on molecular biology/microarrays, food diagnostics, environment/industry and nuclear/biology isolation.

UK • Surrey Tel: (44) 0-13-7272-8980 Web: abplimited.com E-mail: info@abpcorp.com Develops, manufactures, and markets products necessary for hemostasis, thrombosis, and platelet function.

Ameritek USA USA • Everett , WA Tel: (1) 425-379-2580 Web: ameritek.org E-mail: info@ameritek.org Develops and manufactures rapid test kits for point-of-care markets and ELISA kits for laboratories. The test kits are used to detect a number of conditions such as pregnancy, ovulation, various infectious

AMS Alliance

Analyticon Biotechnologies Germany • Lichtenfels Tel: (49) 6454-7991-0 Web: analyticon-diagnostics.com E-mail: info@ analyticon-diagnostics.com Specializes in complete system solutions for small- to medium-sized labs, including analyzers, reagents, controls, and calibrators. Product lines focus on clinical chemistry, hematology, coagulation, and urinalysis.

Ansh Labs USA • Webster, TX Tel: (1) 281-404-0260 Web: anshlabs.com E-mail: sales@anshlabs.com Specializes in immunoassays with potential applications in reproductive medicine, glucagon regulation, neurodegenerative disorders, oncology, etc. Company’s products consist of emerging and maturing assays and monoclonal antibody development that are used by research and clinical labs around the world.

Apacor UK • Wokingham, Berkshire Tel: (44) 118-9795566 Web: apacor.com E-mail: sales@apacor.com Develops and markets practical and cost-effective solutions in the field of medical diagnostics. Products are designed for microbiology and clinical chemistry applications and testing procedures, and specialize in parasitology.

Apel

try. Reagents produced are used in rapid tests for pregnancy, drug abuse, infectious diseases, etc. Custom applications include tumor markers and other disease state applications.

supplies generic and branded pharmaceuticals, medical disposables, medical, and laboratory equipment, and blood glucose and cholesterol monitoring products.

Artel

AUDIT MicroControls

USA • Westbrook, ME Tel: (1) 888-406-3463 Web: artel-usa.com E-mail: info@artel-usa.com Focuses on improving process productivity and quality by providing easy-to-use systems for validating liquid delivery performance.

USA • Eatonton, GA Tel: (1) 866-252-8348 Web: auditmicro.com E-mail: customerservice@auditmicro.com Supplies daily quality control and calibration verification/linearity materials to clinical laboratories worldwide.

Asan Pharmaceutical

Autobio Diagnostics

Korea • Seoul Tel: (82) 2-3290-5700 Web: asanpharm.co.kr E-mail: global@asanpharm.co.kr Offers diagnostic products such as DNA chip and protein chip. The company plans to develop vaccines for HBV, HCV, and also new drugs for hepatitis.

China • Zhengzhou Tel: (86) 371-6798-5313 Web: autobio-diagnostics.com E-mail: info@ autobio-diagnostics.com Develops and manufactures clinical diagnostic products including ELISA, chemiluminescence immunoassays, microbiology, and POCT.

Aspyra

AutoGenomics

USA • West Lave Village, CA Tel: (1) 800-437-9000 Web: aspyra.com E-mail: gbennett@aspyra.com Produces CyberLAB, a comprehensive lab management solution that addresses the life cycle of laboratory operations from ordering to reporting and more.

USA • Vista, CA Tel: (1) 760-477-2248 Web: autogenomics.com E-mail: market@autogenomics.com Provides automated microarray-based multiplexing molecular diagnostic platforms that can be used to assess disease signatures with genomic and proteomic markers in the area of genetic disorders, infectious diseases, cancer, and pharmacogenetics.

Association of Public Health Laboratories USA • Silver Spring, MD Tel: (1) 240-485-2723 Web: aphl.org E-mail: linette.granen@aphl.org Provides laboratory continuing education on a variety of topics, including live, cost-effective webinars, and access to CEUs for lab personnel.

Astech Japan • Tokyo Tel: (81) 03-3366-0811 Web: astechcorp.co.jp Designs and produces scientific instruments such as generators and microprocessor-controlled matching network products.

Astell Scientific

Japan • Saitama Tel: (81) 48-280-3055 Web: apel.co.jp E-mail: sales@apel.co.jp Produces medical and analytical devices including hemoglobin and bilirubin meters, as well as colorimeters and spectrophotometers.

UK • Kent Tel: (44) 0-208-309-2031 Web: astell.com E-mail: sales@astell.com Manufactures autoclaves and sterilizers from 33 to 3,000 liters, and decontamination systems for high-containment laboratories.

Apex Biotechnology

Astra Biotech

Taiwan • Hsinchu Tel: (886) 3-564-1952 Web: apexbio.com Manufactures surgical and medical instruments, as well as being involved in the development and production of testing products for blood glucose, cholesterol, hemoglobin, and blood uric acid.

Germany • Luckenwalde Tel: (49) 0-30-74-696-509 Web: astrabiotech.de E-mail: info@astrabiotech.de Offers a wide range of reagents and diagnostic kits for detection of human hormones, genetic diseases, tumor markers, and allergens.

Arista Biologicals USA • Allentown, PA Tel: (1) 484-223-0309 Web: aristabiologicals.com E-mail: info@aristabiologicals.com Designs, develops, manufactures and markets reagents for the rapid diagnostic test indusLINKXPRESS COM

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Atlas Link USA • Manassas, VA Tel: (1) 703-366-3851 Web: atlaslink-inc.com E-mail: info@atlaslink-inc.com Manufactures IVD test kits and

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Manufactures fume hoods, enclosures, and workstations designed to protect the operator or process from potentially harmful fumes, vapors, gases, and particulate.

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AVE Science & Technology China • Hunan Tel: (86) 731-8892-5308 Web: c-ave.com E-mail: IBD.AVE@c-ave.com Specializes in research and development, manufacturing, marketing, and service of medical devices, biological reagents, remote medical diagnosis network, computer software, automatic control devices, medical auxiliary equipments, and more.

Awareness Technology USA • Palm City, FL Tel: (1) 772-283-6540 Web: awaretech.com E-mail: info@awaretech.com Designs and manufactures semi- and fully automatic biochemistry, ELISA, CLIA, and ISE electrolyte analyzers for small- to medium-sized labs. The company also offers ReQuest immunoassay kits, and Dexall allergy-testing solutions.

BBInternational UK • Cardiff Tel: (44) 2920-747232 Web: bbigold.com E-mail: info@bbisolutions.com Supplies diagnostic and therapeutic reagents and conjugates, gold and silver labeling of proteins and oligonucleotides, as well as quality control sera for molecular diagnostic tests.

BD Diagnostics USA • Franklin Lakes, NJ Tel: (1) 201-847-6800 Web: bd.com/ds Manufactures and sells medical supplies, devices, labora-

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LabMedica 300 tory equipment, and diagnostic products.

Beckman Coulter USA • Brea, CA Tel: (1) 714-993-5321 Web: beckmancoulter.com Manufactures biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes.

Bel-Art Products

Berthold Technologies Germany • Bad Wildbad Tel: (49) 7081-177-0 Web: berthold.com E-mail: info@berthold.com Offers a broad line of bioanalytical instruments including gamma counters, luminometers, flurometers, imaging systems, and HPLC detectors.

Bio-Rad Laboratories BioFire Diagnostics A BioMerieux Company

Benchmark Scientific

USA • Salt Lake City, UT Tel: (1) 801-736-6354 Web: biofiredx.com E-mail: info@biofiredx.com Specializes in the manufacturing, marketing and sales of the FilmArray molecular diagnostics system.

USA • Edison, NJ

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USA • Wayne, NJ Tel: (1) 973-694-0500 Web: belart.com E-mail: feedback@belart.com Manufactures and distributes over 3,500 items from safety wash bottles to fume hoods, distributed under well known brand names such as Scienceware, PLUM, Sterileware, Magic Touch, Secador and HB Instrument.

Tel: (1) 908-769-5555 Web: benchmarkscientific.com E-mail: info@ benchmarkscientific.com Specializes in equipment and instrumentation for the life sciences laboratory. Products include dry baths, homogenizers, pipettes, electrophoresis equipment, shakers, rockers, vortexers, and minicentrifuges.

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USA • Hercules, CA Tel: (1) 510-724-7000 Web: bio-rad.com E-mail: diagcs@bio-rad.com Provides a full range of instrumentation, reagent kits, software and quality control systems to clinical laboratories. Areas of expertise include autoimmune, infectious disease, diabetes monitoring, hemoglobin screening, quality control, HIV, and hepatitis testing.

BioAssay Works USA • Ijamsville, MD Tel: (1) 301-874-8888 Web: bioassayworks.com E-mail: sales@bioassayworks.com Offers gold sol nanoparticles (10 to 50 OD), gold conjugates, and rapid assay development services, including custom conjugation.

Bioer Technology China • Hangzhou Tel: (86) 571-8777-4575 Web: bioer.com.cn E-mail: overseas@bioer.com.cn Focuses on researching and manufacturing high-tech products for life science applications including instrumentation, related reagents, disposables, general lab equipment, and temperature baths.

Biohit HealthCare Finland • Helsinki Tel: (358) 9-773-861 Web: biohithealthcare.com E-mail: info@biohit.fi Develops, manufactures and markets diagnostic tests and analysis systems.

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Biolabo France • Maizy Tel: (33) 323 25 15 50 Web: biolabo.fr E-mail: sales@biolabo.fr Produces reagents and offers a comprehensive range of kits for biochemistry, coagulation and specific proteins. The company also produces polyvalent QC Sera and multicalibrators for biochemistry.

Biomat Italy • Rovereto Tel: (39) 0464 443320 Web: immunosurface.com E-mail: info@immunosurface.com Manufactures microplates and other articles for ELISA, molecular biology, HTS-TC, and research, with a complete range of surfaces and coatings for all applications.

Biomedical Polymers USA • Gardner, MA Tel: (1) 978-632-2555 Web: biomedicalpolymers.com E-mail: sales@ biomedicalpolymers.com Manufactures plastic consumables for research and medical diagnostic laboratories.

Biomerica USA • Irvine, CA Tel: (1) 949-645-2111 Web: biomerica.com E-mail: bmra@biomerica.com Develops, manufactures, and sells products designed to detect diseases in the areas of cancer, cardiology, fertility, gastroenterology, diabetes, allergy, and infectious diseases.

BioMerieux France • Marcy l'Etoile Tel: (33) 4-7887-2000 Web: biomerieux.com Designs, develops, manufactures and markets in vitro diagnostics systems used in clinical and industrial applications.

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E-mail: customercare@biotek.com Developer and supplier of microplate instrumentation and software solutions used in drug discovery, genomics and proteomics, and life science research.

BIORON Diagnostics

Biotron Diagnostics

Germany • Ludwigshafen Tel: (49) 621-5459-0070 Web: bioron.de E-mail: info@bioron.de Develops, produces, and markets a wide range of open-system, real-time PCR kits for the detection of pathogens, especially STIs.

USA • Hemet, CA Tel: (1) 951-658-7766 Web: biotrondiagnostics.com E-mail: sales@ biotrondiagnostics.com Develops and manufactures a complete line of kits and reagents for IVD.

Block Scientific

BioSampling Systems France • Paris Tel: (33) 1-34-30-42-00 Web: biosamplingsystems.net E-mail: marketing@ biosamplingsystems.com Provides full sample management solutions such as software, automates, readers, accessories, and consumables for pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, and research institutions.

USA • Bohemia, NY Tel: (1) 631-589-1118 Web: blockscientific.com E-mail: info@blockscientific.com Provides reconditioned laboratory equipment as an alternative to purchasing new. Areas of specialty include blood gas, electrolyte, chemistry and hematology, with products such as consumables, parts, reagents, and technical service also available.

Blue Cross Bio-Medical

Biosearch Technologies USA • Novato, CA Tel: (1) 415-883-8400 Web: biosearchtech.com E-mail: info@biosearchtech.com Designs and manufactures nucleic acid-based products that accelerate the discovery and application of genomic information.

Biosigma Italy • Cantarana Di Cona Tel: (39) 4-2630-2224 Web: biosigma.com E-mail: info@biosigmaeu.com Specializes in the production of optical multisample cuvettes and cups, as well as a wide range of disposable labware.

BioSystems Spain • Barcelona Tel: (34) 93-311-0811 Web: biosystems-sa.com Develops and manufactures reagents and instruments for clinical analysis.

Biotech Company of China China • Nanchang Tel: (86) 791-8816-8999 Web: biotech.com.cn E-mail: BTSW@biotech.com.cn Provides a range of diagnostic instruments and reagents for medical and clinical applications.

China • Beijing Tel: (86) 10-6975-6015 Web: bcbmcn.com E-mail: market@bcbmcn.com Manufactures in vitro rapid test kits. Main products include the test strips and cassettes for fertility, hepatitis B&C, drugs of abuse, infectious diseases, tumor marker, and sexually transmitted diseases.

Boule Medical Sweden • Spanga Tel: (46) 8-7447700 Web: boule.com E-mail: kenneth.wikner@boule.com Specializes in hematology diagnostics, and developed the very first European blood cell counter. The company’s products include instruments, reagents, calibrators and controls that are used by healthcare providers around the world and are currently sold in more than 100 countries.

BPC BioSed Italy • Rome Tel: (39) 6-907-3666 Web: bpcbiosed.it E-mail: info@bpcbiosed.it Designs, manufactures, and distributes clinical chemistry analyzers and relative reagents worldwide.

Biotecnica Instruments Italy • Rome Tel: (39) 6-411-2316 Web: biotecnica.it E-mail: bt@biotecnica.it Designs and manufactures standard and OEM clinical chemistry equipment and relevant reagent products intended for private and state clinical laboratories including photometers, automatic analyzers, and ion selective analyzers.

BioTek Instruments USA • Winooski, VT Tel: (1) 802-655-4740 Web: biotek.com

Brand Germany • Wertheim Tel: (49) 9342-808-0 Web: brand.de E-mail: info@brand.de Develops, produces and supplies measuring and dispensing instruments. Product applications include chemistry, medicine, pharmacy and biotechniques.

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Denmark • Gentofte LINKXPRESS COM

Tel: (45) 4529-0001 Web: bioporto.com E-mail: info@bioporto.com Focuses on diagnosis and monitoring of critically ill patients by means of analyses suitable for point-of-care (POC) testing.

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LabMedica 300 Bühlmann Laboratories Switzerland • Schönenbuch Tel: (41) 61-487-12-12 Web: buhlmannlabs.ch E-mail: info@buhlmannlabs.ch Produces a range of diagnostic tests and analyzers including rapid tests, ELISAs, and molecular diagnostics solutions.

Calbiotech USA • Spring Valley, CA Tel: (1) 619-660-6162 Web: calbiotech.com E-mail: info@calbiotech.com Specializes in the custom design of immunoassays including ELISA, ultra-sensitive Chemiluminescence ELISA, RIA, and assays for multiplexing platforms. The company also offers products for in vitro research such as endocrine markers, cardiac markers, cancer markers, drugs of abuse, infectious disease, and autoimmune markers.

Callegari Italy • Parma Tel: (39) 05-21-273274 Web: catellanigroup.com E-mail: mauro.codeluppi@ catellanigroup.com Focuses on supplying effective and efficient diagnostic systems that are innovative, fast and simple to use, to operators in the medical, pharmaceutical, wellness and beauty sectors.

CANDOR Bioscience

Web: canterburyscientific.com E-mail: info@ canterburyscientific.com Manufactures freeze-dried and ready-to-use liquid quality hemoglobin controls for hematology and biochemistry diagnostic tests. Products are used for monitoring blood tests and calibrating equipment and processors on in vitro diagnostic analyzers.

Capp

Germany • Wangen Tel: (49) 7522-795270 Web: candor-bioscience.de E-mail: info@candor-bioscience.de Develops, produces, and distributes over 50 different products for immunoassays including optimizers, blockers, stabilizers, and buffer solutions.

Denmark • Odense Tel: (45) 6613-6140 Web: capp.dk E-mail: info@capp.dk Develops and manufactures laboratory liquid handling instruments. Products include pipettes, pipette tips, and microplate washers.

Canterbury Scientific

Caretium Medical Instruments

New Zealand • Christchurch Tel: (64) 3-343-3345

China • Shenzhen Tel: (86) 755-2527-3714

Web: caretium.com E-mail: info@caretium.com Develops and manufactures products that include biochemistry analyzers, microplate readers, electrolyte analyzers, and erythrosedimentation rate analyzers.

Carewell Biotech India • New Delhi Tel: (91) 11-4153-9602 Web: carewellindia.com E-mail: info@carewellindia.com Designs, manufactures, and markets diagnostic products such as electrolyte analyzers and blood glucose monitoring systems in several countries under OEM brands.

Carl Zeiss MicroImaging Germany • Jena Tel: (49) 3641-64-3161 Web: zeiss.de/micro E-mail: info.microscopy.de@ zeiss.com Specializes in the optical and optoelectronic industries. The company products for semiconductor and optoelectronic technology, life sciences, healthcare, and eye care.

Carolina Liquid Chemistries USA • Winston-Salem, NC Tel: (1) 877-722-8910 Web: carolinachemistries.com Manufactures bar-coded chemistry reagents, parts, supplies, and service for use on Beckman Synchron and the Olympus AU series of instruments.

Carperlabs Colombia • Bogota Tel: (57) 310-763-2091 Web: carperlabs.com.co E-mail: info@carperlabs.com Manufactures and merchandizes reagents for in vitro diagnositcs for use in clinical laboratories and blood banks.

Cecil Instruments UK • Cambridge Tel: (44) 1223-420-821 Web: cecilinstruments.com E-mail: info@cecilinstruments.com Designs and manufactures HPLC systems, ion chromatographs, and UV/visible spectrophotometers.

Cellasys Germany • Munich Tel: (49) 89-2000-11074 Web: cellomics.eu E-mail: info@cellasys.com Offers systems solutions for online analysis of living cells, including services such as research and development, production, and maintenance of cell-based assays.

CellaVision Sweden • Lund Tel: (46) 46-286-4400 Web: cellavision.com E-mail: info@cellavision.com Develops systems for the routine analysis of blood and other fluids, which provide critical results used in the diagnosis of a variety of diseases such as infection and cancer.

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Cepheid

C-LA Europe

USA • Sunnyvale, CA Tel: (1) 408-541-4191 Web: cepheid.com E-mail: marketing@cepheid.com Specializes in clinical molecular diagnostics assays with real-time PCR detection, and focuses on research and development.

UK • Thame, Oxfordshire Tel: (44) 1844-355472 Web: claeurope.eu E-mail: info@claeurope.eu Produces pharmaceutical products including a range of retractable and auto-retractable safety syringes designed to be unique, cost effective, and simple to use.

Ceragem Medisys

Clinical Diagnostic Solutions

Korea • Cheonan Tel: (82) 41-551-0600 Web: ceragemmedisys.com E-mail: overseas@ ceragemmedisys.com Designs and manufactures blood diagnostics products including POC equipment for measuring blood glucose, hemoglobin, lactate, HbA1c, CRP, and hematocrit.

Certest Biotec Spain • San Mateo de Gallego Tel: (34) 976-520-354 Web: certest.es E-mail: sales@certest.es Develops and manufactures IVD diagnostic products and real-time PCR diagnostic products for human applications.

Chema Diagnostica Italy • Monsano Tel: (39) 731-605-064 Web: chema.com E-mail: mail@chema.com Develops and manufactures a wide range of liquid stable reagents for the clinical chemistry and immunochemistry industries.

Chembio Diagnostic Systems USA • Medford, NY Tel: (1) 631-924-1135 Web: chembio.com Develops, manufactures, and markets rapid tests for the detection of HIV, TB, Chagas, and other infectious diseases.

Chemtron Biotech China • Shanghai Tel: (86) 21-6812-9988 Web: chemtronbio.com E-mail: international@ chemtronbio.com Specializes in the development, manufacture and marketing point-of-care (POC) in vitro immunodiagnostic rapid tests for the detection and management of pregnancy, ovulation fertility, infectious diseases, cancers, drugs of abuse, myocardial tissue damage and the onset of menopause. Sample formats include test strips, cassettes, midstream, and cups.

Chromsystems Instruments & Chemicals Germany • Munich Tel: (49) 89-18930-0 Web: chromsystems.de E-mail: mailbox@ chromsystems.com Offers an easier method for routine clinical diagnostic procedures with simple applications.

Chronolab Spain • Barcelona Tel: (34) 617-722-466 Web: chronolab.com Produces and distributes diagnostic reagents, as well as laboratory equipment. The company also works with digital image analysis and its transfer, aiming to enable experts to look at the image of blood smear.

USA • Plantation, FL Tel: (1) 954-791-1773 Web: cdsolinc.com Manufacturer of high quality, low cost instrumentation, reagents, controls, and calibrators.

CLONIT Italy • Milan Tel: (39) 02-5681-4413 Web: clonit.it E-mail: info@clonit.it Develops products for in vitro diagnostics with particular attention to the detection of viral, bacteria, and protozoa infections, genetic mutations, and oncological diseases. Products available include ready-to-use diagnostic kits that are userfriendly for routine diagnostic laboratories.

Copan Diagnostics USA • Murrieta, CA Tel: (1) 951-696-6957 Web: copanusa.com E-mail: marketing@copanusa.net Manufactures and distributes laboratory products including transfer pipettes, TOA caps, and autoanalyzer cups.

Corgenix USA • Broomfield, CO Tel: (1) 303-457-4345 Web: corgenix.com E-mail: info@corgenix.com Develops, manufactures and markets clinical laboratory diagnostic products. The REAADS product range of ELISA-based assays focuses on the diagnosis and management of selected autoimmune disorders, vascular disease, and thrombotic tendency using immunological technology.

Coris BioConcept Belgium • Gembloux Tel: (32) 81-719-917 Web: corisbio.com E-mail: info@corisbio.com Develops, manufactures, and markets a wide range of rapid antigen tests for detection of enteric, gastric, and respiratory diseases.

Cormay Poland • Lomianki Tel: (48) 22-751-79-10 Web: cormay.pl E-mail: office@cormay.pl Designs and manufactures a range of products for clinical chemistry, hematology, electrophoresis, coagulation, and specific proteins.

Cornley Hi-Tech China • Shenzhen Tel: (86) 755-8633-0432 Web: cornley.com E-mail: emily@cornley.com Manufactures diagnostic analyzers, including equipment for electrolytes analysis, blood gas analysis, and TCO2 analysis.

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LabMedica 300 CPC Diagnostics

Crony Instruments Italy • Rome Tel: (39) 6-4396432 Web: crony.com E-mail: sales@crony.it Develops and manufactures a wide range of instruments for use in clinical chemistry, immunology, and coagulation. USA • San Diego, CA Tel: (1) 858-457-8698 Web: ctkbiotech.com E-mail: info@ctkbiotech.com Develops and manufactures innovative rapid tests, ELISA kits, and external controls.

Cytocell UK • Cambridge Tel: (44) 1223-294048 Web: cytocell.com E-mail: probes@cytocell.com Develops and manufactures FISH probes for use in both routine cytogenetics and in the analysis and classification of various types of cancer.

Cytognos

D-tek Belgium • Mons Tel: (32) 65-84-18-88 Web: d-tek.be E-mail: info@d-tek.be Develops diagnostic products for autoimmunity and gastroenterology, including the BlueDot and BlueWell product lines,

China • Guangzhou Tel: (86) 20-3229-0789-205 Web: http://en.daangene.com E-mail: marketing@ daangenel.com Produces and services IVD products, including PCR, TRF, ELISA and RAPID diagnostic kits and equipment.

Das Italy • Rome Tel: (39) 0774-637070 Web: dasitaly.com Designs and manufactures analyzers and automated equipment. Main fields of application are immunoenzymatic, immunofluorescence, and clinical chemistry.

Delcon Italy • Milan Tel: (39) 039-617670 Web: delcon.it Manufactures blood bank equipment, laboratory refrigerators, and molecular biology devices. Company also distributes slide stainers, osometers, cystic fibrosis diagnostic devices, and liquid nitrogen containers.

Deltalab Spain • Barcelona Tel: (34) 93-699-5000 Web: deltalab.es E-mail: marketing@deltalab.es Manufactures a range of containers and disposables, along with pipettes and liquid handling systems.

Denka Seiken Japan • Tokyo Tel: (81) 3-6214-3236 Web: denka-seiken.jp E-mail: seiken@denkaseiken.co.jp Develops, manufactures, and distributes in vitro diagnostic reagents and vaccines. Top export products include direct and automatable HDL and LDL

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Manufactures and supplies rapid tests, ELISA, IFA, chemiluminescence, and serology kits.

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DFI Korea • Gimhae Tel: (82) 55-346-1882 Web: cybow.com E-mail: info@dficare.com Researches, develops and manufactures in vitro diagnostic products for urinalysis, including the Cybow series of products.

DIA.PRO Diagnostic Bioprobes Italy • Milan Tel: (39) 02-2700-7161 Web: diapro.it E-mail: info@diapro.it Develops and manufactures in vitro immunoassays for the diagnosis of infectious diseases.

Diagast France • Loos Tel: (33) 3-20-96-53-53 Web: diagast.com E-mail: contact@diagast.com Specializes in the transfusion field, and produces its own immunohematology cells lines, monoclonal antibodies and develops the reagents associated to E.M. technology, microplates, and manual techniques.

DiagCor Bioscience China • Hong Kong Tel: (852) 2147-4088 Web: diagcor.com E-mail: sales@diagcor.com Provides products and services for the diagnostic healthcare and research sectors, including equipment, instrumentation, and kits for analysis and research.

Diagnostic Automation / Cortez Diagnostics USA • Calabasas, CA Tel: (1) 818-591-3030 Web: rapidtest.com E-mail: onestep@rapidtest.com

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Diagnostica Stago France • Asnières sur Seine Tel: (33) 1-4688-2020 Web: stago.com E-mail: webmaster@stago.com Offers a complete system of hemostasis instrumentation and optimized reagent kits for research, as well as for routine analysis. SEE AD ON PAGES 39

Diagnosticum Hungary • Budapest Tel: (36) 1-369-07-39 Web: diagnosticum.hu E-mail: business@diagnosticum.hu Develops and markets biochemistry reagents and immunology kits, with applications for open analyzers.

Diamedix An Erba Mannheim Company USA • Miami, FL Tel:(1) 305-324-2300 Web: diamedix.com E-mail: customerservice@ diamedix.com Focuses on the development of integrated instrument and reagent systems for both autoimmune and infectious disease detection.

Diametra Italy • Milan Tel: (39) 02 2139184 Web: diametra.com E-mail: info@diametra.com Focuses on the manufacture of ELISA immunoassay kits, as well as offering a wide range of analytes for various applications.

Diamond Diagnostics USA • Holliston, MA Tel: (1) 508-429-0450

Web: diamonddiagnostics.com E-mail: main@ diamonddiagnostics.com Specializes in refurbished e”quipment for chemistry, immunology, hematology, coagulation, microbiology, flow cytometry, and blood gases. The company also manufactures reagents, electrodes, tubing, probes, and QC materials for use in a wide range of brands, as well as the SmartLyte, ProLyte, and CareLyte lines of electrolyte analyzers.

DiaProbe Korea • Seoul Tel: (82) 2912-7933 Web: diaprobe.com E-mail: master@diaprobe.com Develops and manufactures real-time PCR kits for clinical chemistry and POC testing.

DiaSorin Italy • Saluggia

Diagon Hungary • Budapest Tel: (36) 1-369-6500 Web: diagon.com E-mail: diagon@diagon.com Produces hematology reagents and develops reagents for new hematology analyzers that appear on the market.

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Spain • Santa Marta de Tormes Tel: (34) 923-125-067 Web: cytognos.com E-mail: admin@cytognos.com Designs and develops new reagents, software, and techniques that offer solutions in the field of flow cytometry.

Da An Gene

reagents, latex-enhanced serum protein tests for hsCRP, rheumatoid factor, myglobin, ferritin and others, as well as rapid diagnostic test kits for MRSA, E. coli O157, parvo B19, Norwalklike and influenza viruses.

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CTK Biotech

and along with liquid substrates and stabilizers.

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India • Chennai Tel: (91) 44-2499-3989 Web: cpcdiagnostics.in E-mail: info@cpcdiagnostics.in Specializes in lab products that focus on clinical chemistry, hematology and coagulation, immunodiagnostics, molecular diagnostics and research, and pre-analytical automation.

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Dialab Austria • Wiener Neudorf Tel: (43) 2236-660910-0 Web: dialab.at E-mail: office@dialab.at Manufactures and distributes diagnostics and laboratory equipment, supplying a range of products, based on clinical chemistry reagents, immunological reagents, and coagulation reagents.

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Dirui Industrial China • Changchun Tel: (86) 188-4453-6781 Web: dirui.com.cn E-mail: mason.jin@dirui.com.cn Specializes in R&D and manufacturing of products for urine analyzers, including urine strips.

China • Beijing Tel: (86) 10-8565-3451 Web: dragon-lab.com E-mail: info@dragon-lab.com Manufactures laboratory instruments for researchers in both the scientific and clinical fields, focusing on two product lines: liquid-handling devices – including mechanical electronic and autoclavable pipettes, and pipetting aids – and diagnostic instruments, such as erythrocyte sedimentation rate analyzers.

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Diatron Hungary • Budapest Tel: (36) 1-436-9800 Web: diatron.com E-mail: sales@diatron.com Specializes in the development, manufacturing and marketing of hematology analyzers, reagents, and control material, plus clinical chemistry analyzers, reagents, and controls.

Diazyme Laboratories USA • Poway, CA Tel: (1) 858-455-4768 Web: diazyme.com E-mail: sales@diazyme.com Develops test kits and reagents for the diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, and electrolytes.

Diesse Diagnostica Senese

Germany • Holzheim Tel: (49) 6432-9146-0 Web: diasys-diagnostics.com E-mail: info@diasys.de Develops, manufactures, and

Canada • Ottawa, ON Tel: (1) 613-723-5757 Web: dnagenotek.com E-mail: info@dnagenotek.com Develops products that enable easy collection, stabilization, transportation, and preparation of DNA and RNA samples.

Dragon Laboratory Instruments

DxGen

DRG International USA • Springfield, NJ Tel: (1) 973-564-7555 Web: drg-international.com E-mail: marketing@ drg-international.com Provides complete range of products and services to the diagnostics and cardiology-related medical community. The company is constantly looking towards the future in order to continue to produce and distribute the highest-quality diagnostic products in clinical chemistry, immunology and microbiology that are cutting

Korea • Gunpo Tel: (82) 31-427-8450 Web: dxgenco.com E-mail: sales@dxgenco.com Develops multi-markers for people with diabetes and tuberculosis. The Epithod 616 system is the first POC analyzer for entire stages of diabetes care to measure both Glycated Albumin and HbA1c.

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DiaSys Diagnostic Systems

Italy • Siena Tel: (39) 05-77-587111 Web: diesse.it E-mail: salesoffice@diesse.it Products include: Erythrocyte sedimentation rate test; modular instrument for bacteriological screening and isolation of microorganisms in urine and stool; complete line of Elisa test kits, which offer common reagents; multiparametric analyzer for in-

DNA Genotek

SEE AD ON PAGE 38

SEE AD ON PAGE 31

ies, and specialized immunoassay reagents for the diagnostic manufacturing industry. Products include SeaBlock fish plasma blocking reagents, as well as cardiac markers, DOA, hormones, infectious diseases, serum proteins, and tumor markers.

Web: erbamannheim.com E-mail: m.manish@ erbamannheim.com Provides a range of analyzers and reagents. Products available focus on clinical chemistry, immunology, hematology, coagulation, critical care, urine analysis, diabetes monitoring, autoimmune and infectious disease monitoring, and microbiology.

EKF Diagnostics

Eppendorf

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SEE AD ON PAGE 10

edge, easy-to-use and effective.

UK • Cardiff Tel: (44) 29-20-710570 Web: ekfdiagnostics.com E-mail: info@ ekfdiagnostics.com Focuses on the POC market with over 80,000 hemoglobin, HbA1c, glucose and lactate analyzers in regular use in more than 100 countries running more than 70m tests every year. The company is also a global manufacturer of central lab products including Stanbio chemistry reagents.

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Belgium • Louvain-La-Neuve Tel: (32) 10-84-99-11 Web: diasourcediagnostics.com E-mail: info@diasource.be Develops, manufactures, and markets clinical diagnostic products that focus on endocrinology and infectious diseases.

fectious diseases and autoimmunity; agglutination tests for CRP, RF, ASO, Febrile Antiges and complement fixation tests for manual procedure.

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DIAsource ImmunoAssays

distributes diagnostic systems for clinical chemistry and immunoturbidimetry. Supplies high-quality reagents for routine and special diagnostics, as well as automated analyzers for laboratory and POC.

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Tel: (39) 0161-4871 Web: diasorin.com E-mail: marketing@diasorin.it Develops and manufactures reagents for in vitro diagnostics. Areas of specialty include infectious disease, hepatitis, endocrinology, bone and mineral metabolism, cancer, brain injury, cardiac, therapeutic drug monitoring and autoimmunity.

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ELGA LabWater UK • Lane End Tel: (44) 0-203-567-7300 Web: elgalabwater.com E-mail: info@elgalabwater.com Specializes in providing purified laboratory water for research and testing, healthcare, and clinical diagnostics applications.

Drucker Diagnostics USA • Port Matilda, PA Tel: (1) 814-692-7661 Web: druckerdiagnostics.com E-mail: sales@ druckerdiagnostics.com Develops, manufactures, and markets a wide range of centrifuges for use in medical, research, educational, and industrial laboratories.

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ELITech Group France • Paris Tel: (33) 0-1-41-45-07-10 Web: elitechgroup.com E-mail: info@elitechgroup.com Offers a range of products for in vitro diagnostics in clinical chemistry, hemostasis, microbiology, immunology, and electrophoresis.

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China • Shenzhen Tel: (86) 0755-2600-8015 Web: dymind.com.cn E-mail: hrdymind@dymind.com.cn Specializes in the manufacture and sales of products that include in vitro diagnostic medical devices and home ventilators.

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Dynex Technologies USA • Chantilly, VA Tel: (1) 703-631-7800 Web: dynex.com E-mail: productinfo@dynex.com Designs and manufactures innovative ELISA instruments, including the Agility automated system with SmartKit technology. As a leader in automated microplate technology, the company offers the new Multiplier Flex system with M2 multiplexed microwell technology.

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Germany • Hamburg Tel: (49) 4053-8010 Web: eppendorf.com E-mail: eppendorf@eppendorf.de Develops, manufactures, and distributes systems comprising instruments, consumables, and reagents. The company focuses on two areas: bio tools – including pipettes, dispensers, and centrifuges and consumables such as test tubes and pipette tips; and molecular technologies – which includes instruments and systems for cell manipulation, automatic devices for highthroughput screening (HTS), complete systems for DNA multiplication, nucleic acid purification kits, and biochips.

Erba Lachema Czech Republic • Brno Tel: (42) 517-077-111 Web: erbalachema.com E-mail: diagnostics@lachema.com Develops, manufactures, and markets products for urine analysis, clinical chemistry, and bacterial identification.

Esco Micro Singapore • Singapore Tel: (65) 6542-0833 Web: escoglobal.com E-mail: mail@escoglobal.com Delivers controlled environment, lab and cleanroom equipment solutions to the clinical, life science, research, and industrial laboratory community.

Esteriplas

EMD Millipore Dymind Biotech

SEE AD ON PAGES 7, 9

USA • Billerica, MA Tel: (1) 781-533-6000 Web: millipore.com Focuses on bioprocess and bioscience products and is organized into two divisions. The Bioprocess division offers solutions for the development and manufacturing of biologics, while the Bioscience division provides products and applications that improve laboratory productivity.

Portugal • Santa Maria da Feira Tel: (351) 256-330350 Web: esteriplas.pt E-mail: info@topstar.pt Develops, manufactures and distributes a wide range of hospital, clinical lab, safety and hygienic products. The company created the Toplabs catalog, which includes quality products such as TopStar glucose solution, ZeroDNA and Mycoplasmafree.

Emperor Electronic Technology

Euro-Diagnostica

China • Shenzhen Tel: (86) 755-2607-3285 Web: china-emperor.com E-mail: business@ china-emperor.com Specializes in the development, manufacture, and distribution of in vitro devices including chemistry analyzers, urine analyzers, and immunology analyzers.

Sweden • Malmo Tel: (46) 40-53-76-00 Web: eurodiagnostica.se E-mail: info@eurodiagnostica.com Develops, manufactures and markets diagnostic kits and reagents for use in medical assessments. Product applications include clinical autoimmunology, microbiology, histology/cytology, and immunochemistry.

EastCoast Bio

Eurobio

USA • North Berwick, ME Tel: (1) 207-676-7639 Web: eastcoastbio.com E-mail: info@eastcoastbio.com Manufactures and supplies high-quality antigens, antibod-

France • Courtaboeuf Tel: (33) 1 69 07 94 77 Web: eurobio.fr Develops, produces and sells a complete range of reagents and biochemicals for the diagnostic and research markets.

Erba Diagnostics Mannheim Germany • Mannheim Tel: (49) 621-8799770

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LabMedica 300 EuroClone Italy • Milan Tel: (39) 02-38195-1 Web: euroclone.it E-mail: info@euroclone.it Specializes in cell biology, cytogenetics, genomics, and proteomics, providing the clinical chemistry industry with instruments, reagents and kits, as well as lab equipment and supplies for contamination control.

Euroimmun Germany • Lübeck Tel: (49) 451 58 55 0 Web: euroimmun.com E-mail: euroimmun@ euroimmun.de Designs and manufactures products for autoimmune and infection diagnostics, allergology and molecular diagnostics. The product range includes indirect immunofluorescence, ELISA, immunoblot, radioimmunoassay and molecular genetic test systems, as well as state-of-the-art instruments, software and automation systems.

Eurospital Italy • Trieste Tel: (39) 040 8997 1 Web: eurospital.com Develops and manufactures diagnostic medical devices for the in vitro diagnosis of Celiac diseases, inflammatory bowel disease, Helicobacter pylori, and infectious diseases.

Eurotrol USA • Burlington, MA Tel: (1) 978-598-3779 Web: eurotrol.com E-mail: officeusa@eurotrol.com Provides QC materials to the diagnostic laboratory market, EQA/PT programs, standardization bodies, hospital labs, and POC.

Express Diagnostics International USA • Blue Earth, MN Tel: (1) 507-526-3951 Web: drugcheck.com E-mail: sales@drugcheck.com Manufactures and distributes DrugCheck onsite urine and saliva screening devices for the detection of over 50 DOA and cutoffs, as well as a growing catalog of rapid alcohol screening and health diagnostics devices.

Fluid Metering USA • Syosset, NY Tel: (1) 516-922-6050 Web: fluidmetering.com E-mail: pumps@fmipump.com Manufactures metering pumps and dispensers with a valveless, positive displacement design.

ized testing services, diagnostic products and anti-infective surveillance and consultative services for the diagnosis, treatment and management of infectious diseases.

Fortress Diagnostics UK • Antrim Tel: (44) (0) 2894-487676 Web: fortressdiagnostics.com E-mail: info@fortressdiagnostics.com Develops and manufactures a portfolio of POC and clinical diagnostic test kits across a spectrum of disciplines. Company products can be found in clinical chemistry, immunology, hematology and serological laboratories, as well as in blood banks, in more than 100 international markets.

Fosun Diagnostics China • Shanghai Tel: (86) 21-6076-5888 Web: fosundiagnostics.com E-mail: diagnostics@ fosunpharma.com Develops, markets, and distributes in vitro diagnostic products including real-time PCR analyzers, and a range of genotyping kits.

China • Shenzhen Tel: (86) 755-2683-5560 Web: genrui-bio.com E-mail: international@genrui-bio.com Specializes in developing, manufacturing and marketing IVD equipment and reagents. Product range covers immunoassay, chemistry, hematology, urinalysis, and point-of-care, as well as associated reagents.

GenoID Hungary • Budapest Tel: (36) 1-465-01-24 Web: genoid.net E-mail: genoid@synlab.com Focuses on HPV diagnostics research, offering a real-time PCR test that detects all 14

Getein Biotechnology China • Nanjing Tel: (86) 25-6856-8594 Web: bio-gp.com.cn E-mail: sales@getein.com.cn Develops and manufactures a range of rapid test kits for disease detection, as well as quantitative immunoassay analyzers.

Globe Scientific USA • Paramus, NJ Tel: (1) 201-599-1400 Web: globescientific.com E-mail: mail@globescientific.com Specializes in high quality laboratory plastic and glassware items designed for use in the research, clinical, industrial, and specialty markets. The company also provides custom kit assembly, private label, and custom molding services.

GlysBy Italy • Arcore Tel: (39) 039 6882252

Web: glysby.com E-mail: bidoli@glysby.com Offers OTC diagnostic tests for home- and self-testing. Products also include tests for professional use including ELISA tests, biochemistry kits, and instruments.

GMMC Korea • Seoul Tel: (82) 2-2104-0470 Web: gmmcgroup.com E-mail: info@gmmcgroup.com Manufactures products for POCT, hematology, coagulation, and blood bank, including safety and general lancets, along with containers and disposables.

Goldsite Diagnostics China • Shenzhen Tel: (86) 755-2689-0807 Web: goldsite.com.cn E-mail: marketing@ goldsite.com.cn Specializes in producing serum protein assaying instruments and reagents, including

USA • Malvern, PA Tel: (1) 610-240-3800 Web: fdi.com E-mail: customerservice@fdi.com Manufactures monoclonal antibodies designed to detect a variety of tumor markers. These antibodies have also been used to help develop a menu of in vitro diagnostic tests.

Gemmy Industrial Taiwan • Taipei Tel: (886) 2-2553-1456 Web: gemmy.com.tw E-mail: gemmy888@ gemmy.com.tw Manufactures laboratory equipment, suction units, autoclaves/sterilizers, and ENT treatment units.

General Biologicals Taiwan • Hsin Chu Tel: (886) 3-577-9221 Web: gbc.com.tw E-mail: sales.group@gbc.com.tw Develops and manufactures high-quality IVD and pharmaceutical products for doctors to make clinical decisions in the area of hepatitis, tumor markers, retrovirus, fertility, thyroid and steroids. In general consumables, the company also provides an anti-bacterial peptide in areas of pharmaceutical, cosmetics and oral products.

GeneReach Biotechnology

UK • Salisbury Tel: (44) 1980-612-058 Web: fluorogenics.co.uk E-mail: info@fluorogenics.co.uk Develops and manufactures ambient storage molecular biology reagents, assays, and kits for use in genetic identification, infectious disease detection, veterinary pathology, and applied R&D.

Taiwan • Taichung City Tel: (886) 4-2463-9869 Web: genereach.com E-mail: sales@genereach.com Manufactures and markets products for applied nucleic acid detection technology, including equipment and reagents, as well as diagnostic kits for the point-of-care market.

Focus Diagnostics

GenMark Diagnostics

Genrui Biotech

high-risk HPV types in one reaction.

Fujirebio Diagnostics

Fluorogenics

USA • Cypress, CA Tel: (1) 562-240-6500 Web: focusdx.com Develops and provides special-

E-mail: info@genmarkdx.com Provides cost-effective molecular diagnostic technologies and tools that enable a broader range of hospitals and laboratories to offer molecular diagnostic services for improved patient care.

USA • Carlsbad, CA Tel: (1) 760-448-4300 Web: genmarkdx.com

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Nephstar and Nephstar Plus protein analysis system, along with up to 30 kits for determining specific proteins.

Gongdong Medical Technology China • Zhejiang Tel: (86) 576-8411-5678 Web: chinagongdong.com Manufactures and distributes disposable medical and lab consumables.

Greiner Bio-One International Austria • Kremsmunster Tel: (43) 7583-6791-0 Web: gbo.com E-mail: office@at.gbo.com The Preanalytics division develops, manufactures and distributes venous blood collection devices for hospitals, laboratories and blood banks. The Bioscience division manufactures products for the biomedical industry, including pipettes, PCR plates, reaction tubes, analyzer cups, and cell separation media.

LabMedica 300 Greiner Diagnostic Germany • Bahlingen Tel: (49) 76-6391-490 Web: greiner-diagnostic.com Specializes in developing, manufacturing and marketing a range of clinical diagnostic assays and kits including niche products like oxalate test, and pyruvate kinase deficiency test.

Grifols International Spain • Barcelona Tel: (34) 935-712-200 Web: grifols.com Researches, develops, manufactures and markets plasma derivatives, IV therapy, enteral nutrition, diagnostic systems, and medical materials.

Haier Medical and Laboratory Products China • Qingdao Tel: (86) 138-6988-7923 Web: haiermedical.com E-mail: xiaozh@haier.com Specializes in the design, manufacturing, and marketing of a range of scientific products, such as low-temperature freezers, for various lab applications.

Hanlab

HBI Korea • Gyeonggi-do Tel: (82) 31-682-2100 Web: hbi21.com E-mail: info@hbidiag.com Specializes in clinical chemistry and immunology products for the fields of biochemistry and immunity.

Helena Laboratories USA • Beaumont, TX Tel: (1) 409-842-3714 Web: helena.com Provides specialized, sensitive bedside hemostasis diagnostics for intraoperative platelet

Helmer USA • Noblesville, IN Tel: (1) 317-773-9073 Web: helmerinc.com E-mail: sales@helmerinc.com Manufactures and distributes lab equipment and temperature-controlled products. Blood bank products include refrigerators, freezers, platelet storage systems, and plasma thawing systems. A complete line of centrifuges and accessories is also available.

Hecht - Assistent Germany • Sondheim Tel: (49) 9779-808-0 Web: hecht-assistent.de E-mail: info@hecht-assistent.de Offers products for blood tests and urine analysis, microscopic and staining utensils, liquid handling, water treatment, measuring glass instruments, as well as general lab apparatus, and hydrometers and thermometers.

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Korea • Osong-eup, Chungcheongbuk-do Tel: (82) 43-229-6200 Web: hanlab.com E-mail: hanlab@hanlab.co.kr Develops, produces, and distributes products for clinical chemistry including an automatic self-balancing centrifuge.

aggregation and heparin monitoring.

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HEMCO USA • Independence, MO Tel: (1) 800-779-4362 Web: hemcocorp.com E-mail: info@hemcocorp.com Designs and manufactures laboratory hoods, furniture, enclosures, and clean labs for a range of scientific applications.

HemoCue A Danaher Company USA • Cypress, CA Tel: (1) 800-881-1611 Web: hemocue.com E-mail: web@hemocue.com Develops, produces, and markets products for point-of-care testing. The company’s leading products measure hemoglobin and glucose in whole blood and albumin in urine.

Hemosure USA • Irwindale, CA Tel: (1) 888-436-67873

Web: hemosure.com E-mail: sales@hemosure.com Manufactures the Hemosure Immunological Fecal Occult Blood test (IFOBT) that offers high sensitivity and high specificity, and is easily performed in physician offices, hospitals, and labs.

Hettich Germany • Tuttlingen Tel: (49) 7461-705-0 Web: hettichlab.com E-mail: info@hettichlab.com Provides customers with a complete line of centrifuges. Product applications include clinical chemistry, hematology, cytology and hystology. Centrifuge varieties include microliter, hematocrit, benchtop, underbench, floor-standing, blood bank, robotic centrifuges, refrigerated and nonrefrigerated and cell washers.

HiMedia Laboratories India • Mumbai Tel: (91) 22-6147-1919 Web: himedialabs.com E-mail: info@himedialabs.com Manufactures high quality culture media for microbiology, and offers a complete range of chromogenic and HiVeg media products.

Hitachi Aloka Medical Japan • Tokyo Tel: (81) 422-45-6049 Web: hitachi-aloka.com Involved in the development of nuclear diagnostic, osteoporosis diagnostic, sample testing, and therapeutic/surgical systems.

Hologic USA • San Diego, CA Tel: (1) 858-410-8000 Web: hologic.com E-mail: euinfo@hologic.com Specializes in products for molecular diagnostics including Aptima assays and advanced automation platforms that allow labs to quickly and accurately detect or monitor infectious diseases. The company’s proven solutions are designed

to help promote early detection, appropriate treatment, and better outcomes.

Hongqi Optical Instrument Technology China • Guangzhou Tel: (82) 020-8207-0977 Web: hqbio.com E-mail: info@hqbio.com Specializes in lab instruments, analyzers, rapid tests, kits and consumables for cervical cancer diagnosis, as well as other diagnostic fields.

Horiba Medical France • Montpellier Tel: (33) 4 67 14 15 16 Web: horiba.com/medical Produces hematology and clinical chemistry analyzers, offering small instruments equipped with features for accuracy and reliability.

Horron XLH Medical China • Shenzhen Tel: (86) 755-2685-5736 Web: horron.com E-mail: export@horron.com Specializes in the development and marketing of products for in vitro diagnostics, including a wide range of analyzers, plate washers, and reagents.

HTL Poland • Warsaw Tel: (48) 22-492-19-00 Web: htl.com.pl Specializes in the production of laboratory and medical products including single-channel variable-volume pipettes, multichannel pipettes, fixed-volume pipettes, electronic pipetting controllers, and manual dispensers.

Human Diagnostics Germany • Wiesbaden Tel: (49) 6122-9988-0 Web: human.de E-mail: human@human.de Develops and manufactures diagnostic products for clinical laboratories including in vitro, clinical chemistry, POC testing, immunology, microbiology, hematology, and coagulation.

Humasis Korea • Dongan-gu, Anyang-si Visit us at

Arab Health

Stand Z6.J33

Tel: (82) 31-478-8591 Web: humasis.com Develops and manufactures products for IVD and point-ofcare testing.

Hycor Biomedical USA • Indianapolis, IN Tel: (1) 317-454-8685 Web: hycorbiomedical.com Develops, manufactures and markets automated instruments and reagent systems. The company also offers a line of urinalysis controls and disposable products under the Kova brand.

HyTest Finland • Turku Tel: (358) 2 512 0900 Web: hytest.fi E-mail: hytest@hytest.fi Offers innovative solutions for assay development and research applications by providing high-quality immunological reagents for cardiac markers, Troponin I and Troponin T, infectious disease antibodies, and autoimmune disease reagents.

IBL-America USA • Minneapolis, MN Tel: (1) 888-523-1246 Web: ibl-america.com E-mail: bsavela@ibl-america.com Provides high-quality laboratory reagent assays for research and clinical testing in various areas including autoimmunity, endocrinology, infectious disease, oncology and neuroscience. Products include ELISA kits, RIA kits, chemiluminescent diagnostic and research tools, antibodies and proteins.

iCubio Biomedical Technology China • Shenzhen Tel: (86) 755-2661-0931 Web: icubio.com E-mail: info@icubio.com Develops and markets lab inspection equipment, including biochemistry analyzers.

Immucor Gamma USA • Norcross, GA Tel: (1) 770-441-2051 Web: immucor.com E-mail: info@immucor.com Develops and manufactures products used by hospital blood banks, clinical laboratories, and blood donor centers to detect and identify certain properties of human blood prior to patient transfusion.

Immunetics USA • Boston, MA Tel: (1) 617-896-9100 Web: immunetics.com Produces instruments such as the Miniblotter for Western Blot, spoligotyping and other multiprobe membrane assays. Additional products include a cell adhesion flow chamber for microarray hybridization, the QualiCode line of Western Blot assays and recently, the C6 B. burgdorferi (Lyme) ELISA Kit for Lyme testing.

Immuno Concepts USA • Sacramento, CA Tel: (1) 916-363-2649 Web: immunoconcepts.com Produces diagnostic test kits for autoimmune diseases including slide assays, ELISA assays, and a protein coloriLINKXPRESS COM

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metric microarray containing 10 DNA/ENA antigens.

Immunodiagnostic Systems UK • Boldon, Tyne and Wear Tel: (44) 191-519-0660 Web: idsplc.com E-mail: salessupport.uk@idsplc.com Specializes in immunoassays and creates tools to aid in the diagnosis of diseases of bone and calcium dysfunction such as osteoporosis, osteomalacia and Paget's disease. The company also monitors responses to therapy and studies the fundamental mechanisms of bone disorders. The flagship products of the company are kits for the determination of Vitamin D in human serum.

IMMUNDIAGNOSTIK Germany • Bensheim Tel: (49) 6251 701 900 Web: immundiagnostik.com E-mail: info@immundiagnostik.com Develops innovative immunoassays and other analytical methods for routine testing and research, with a product portfolio that includes a broad range of antibodies and antigens. Company focuses on providing effective tools for prevention, differential diagnosis and therapy monitoring in the areas of gastroenterology, cardiovascular diseases, disorders of the skeletal system and oxidative stress.

INCYTO Korea • Cheonan Tel: (82) 41-550-9762-7 Web: incyto.com E-mail: sales@incyto.com Develops diagnostic and analytical instruments for medical purposes, as well as providing related services and solutions, and focuses on MEMS, bioengineering, and Lab-on-achip techniques.

Inova Diagnostics USA • San Diego, CA Tel: (1) 858-586-9900 Web: inovadx.com Focuses on autoimmune disease diagnostics and offers autoimmune testing reagents. The autoimmune product groups include kits and components for testing for connective tissue disease, coagulation, gastrointestinal disorders, vasculitis, endocrine, autoimmune liver disease, and related infectious disease.

Institute of Isotopes Hungary • Budapest Tel: (36) 1-395-9081 Web: izotop.hu E-mail: izotop@izotop.hu Develops and manufactures radioactive isotopes, as well as immunoassay kits, for clinical and research laboratory use.

Instrumentation Laboratory USA • Bedford, MA Tel: (1) 781-861-4577 Web: instrumentationlaboratory.com E-mail: smccraven@ilww.com Specializes in innovative hemostasis and acute care IVD testing solutions such as the new GEM Premier 5000 system with iQM2; new GEMweb Plus 500 custom connectivity; GEM Premier 4000/3500 sys-

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LabMedica 300 JS Medicina Electronica

tems; ACL TOP Family 50 Series systems; HemoCell specialized lab automation; HemoHub intelligent data manager; ACL AcuStar system and HemosIL assays. Recent TEM/ Accriva acquisitions expanded the product portfolio with ROTEM patient blood management; Hemochron; VerifyNow and Avoximeter systems.

Argentina • Buenos Aires Tel: (54) 11-4709-7707 Web: jsweb.com.ar E-mail: info@jsweb.com.ar Develops and produces medical devices and IVD products, including analyzers, software, electrodes, and consumables.

InTec Products

Kabe Labortechnik

China • Xiamen Tel: (86) 592-7173 Web: intecasi.com E-mail: intecproducts@asintec.com Specializes in R&D, production and distribution of in vitro diagnostic reagents. Products available focus on infectious disease tests, ELISA, PCR methods, drugs of abuse, fertility and tumor marker. Recently added to the product line is a diabetes monitoring system and a rapid test reader.

International Immuno-Diagnostics USA • Foster City, CA Tel: (1) 650-345-9518 Web: intlimmunodiagnostics.com E-mail: contact@ intlimmunodiagnostics.com Offers EIA microwell diagnostic tests, as well as one-step membrane quick screen tests.

Invetech USA • San Diego, CA Tel: (1) 858-768-3232 Web: invetech.us E-mail: info@invetech.com.au Designs and manufactures products, instruments, and custom automation services to in vitro diagnostics, medical devices, life sciences, drug discovery, and pharmaceutical companies.

IQ Products Netherlands • Groningen Tel: (31) 50-575-7000 Web: iqproducts.nl E-mail: marketing@iqproducts.nl Supplies a range of products for perinatal diagnostics, transplantation-related diagnostics, and routine flow cytometry.

IWAKI Japan • Tokyo Tel: (81) 3-3254-2935 Web: iwakipumps.jp Manufactures high-purity metering pumps, chemical delivery pumps, recirculation pumps and nonmetallic magnetic drive centrifugal pumps and systems.

JAJ International USA • San Diego, CA Tel: (1) 858-866-0788 Web: jajinternational.com E-mail: info@jajinternational.com Develops, manufactures, and markets a wide range of onestep diagnostic tests, including cardio markers, infectious diseases, drug abuse, STD, pregnancy, and fertility.

JP Selecta Spain • Barcelona Tel: (34) 937 700 877 Web: grupo-selecta.com E-mail: selecta@jpselecta.es Produces products that include autoclaves, blood bank cabinets, baths, centrifuges, incubators, blood collection tubes, pipettes, and ESR systems, among others.

Germany • Numbrecht-Elsenroth Tel: (49) 22-93-9132-0 Web: kabe-labortechnik.de E-mail: info@kabe-labortechnik.de Develops, manufactures and markets treated and untreated test tubes for different blood, urine and feces examinations, blood collection systems for venous and capillary blood, mixers for blood samples, devices for the blood sugar determination and for the determination of the blood sedimentation rate as well as accessories for the handling and disposal of the products.

Web: kem-en-tec.com E-mail: support@kem-en-tec.com Develops and produces superior, technology-enhanced components for colorimetric- and chemiluminescent-based immunoassays. The company also provides environmentally friendly, ECO-TEC components for immunoassays, along with substrates, buffers and stabilizers for life science customers in 30+ countries.

Lab M UK • Heywood, Lancashire Tel: (44) 161-820-3833 Web: www.labm.com E-mail: info@labm.com Specializes in the development and production of microbiological diagnostic products, including dehydrated culture media and chromogenic media.

Lab21 Healthcare UK • Cambridge Tel: (44) 1223-395-450 Web: lab21.com E-mail: info@lab21.com

Provides molecular diagnostic products and services, along with a range of infectious disease assays, to healthcare organizations, clinical laboratories, and pharmaceutical companies.

LABEX Reagens Sweden • Helsingborg Tel: (46) 42-32-40-00 Web: labexreagens.com E-mail: reagents@labex.com Specializes in reagents and controls for hematology instruments.

Labline Equipments India • Gujarat Tel: (91) 982-504-2088 Web: lablineindia.com E-mail: haresh@lablineindia.com Manufactures brushless centrifuges, needle destroyers, blood mixers, centrifuges, differential blood cell counters, vortex mixers, dry bath incubators, hematocrit digital centrifuges and roller mixers.

Labnovation Technologies China • Shenzhen Tel: (86) 755-8636-8328 Web: labnovation.com E-mail: export@labnovation.com Specializes in reagent manufacturing, and focuses on developing reagents for hematology analyzers, clinical chemistry, and urine cell analyzers.

LabONE India • Chennai Tel: (91) 44-2454-2944 Web: lab1inc.com E-mail: labone.india@gmail.com Manufactures and produces clinical laboratory equipment including ESR and biochemistry analyzers, hemoglobin meters, nephlometers, and total bilirubin meters.

Labtest Brazil • Lagoa Santa Tel: (55) 31-3689-6900 Web: labtest.com.br Develops, manufactures, and

Kaivogen Finland • Turku Tel: (358) 44-584-5062 Web: kaivogen.com E-mail: info@kaivogen.com Produces laboratory reagents for clinical chemistry, genetic testing, immunology, hematology, blood bank, and coagulation applications. Additional products offered include chelates, custom reagents and kit components.

Kamiya Biomedical USA • Seattle, WA Tel: (1) 206-575-8068 Web: k-assay.com E-mail: diagnostics@k-assay.com Manufactures over 38 immunoassay reagents for chemistry analyzers including the new H. pylori reagent and remnant lipoprotein cholesterol reagent for chemistry analyzers. The reagents offer the best performance / lowest price of any comparable reagents, and are available for lipid, diabetes/stroke, anemia, allergy, inflammation, nutrition, kidney and cardiac testing. The company also offers preclinical human and animal biomarker assay reagents and kits.

Kartell Labware Italy • Milan Tel: (39) 2-900-121 Web: kartelllabware.com E-mail: labware@kartell.it Supplies a wide range of lightweight, ergonomic products for the laboratory market including plasticware, disposables, and a range of liquid handling options.

Kehua Bioengineering China • Shanghai Tel: (86) 21-6485-0088 Web: skhb.com E-mail: khbmarketing@khbls.com Develops, manufactures, and markets reagents, automatic clinical chemistry analyzers, microplate readers and washers, electrolyte analyzers, decapping centrifuges, and vacuum blood collection tubes.

Kem-En-Tec Diagnostics Denmark • Taastrup Tel: (45) 3927-1771

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commercializes IVD reagents and diagnostic equipment for the clinical chemistry industry.

Lampire Biological Laboratories USA • Pipersville, PA Tel: (1) 215-795-2838 Web: lampire.com Specializes in polyclonal and monoclonal antibody development, cell culture devices and services, and a wide variety of blood-derived products.

Landwind Medical China • Shenzhen Tel: (86) 755-2735-3211 Web: landwindmedical.com E-mail: sales@ landwindmedical.com Distributes medical diagnostic imaging equipment, as well as products for medical IT, IVD, hemodialysis, and anesthesia.

Lanner Biotechnology Taiwan • Taichung City Tel: (886) 42-355-3201 Web:

LabMedica 300 lanner-instruments.com E-mail: sales@ lanner-instruments.com Manufactures a range of instruments for clinical chemistry, hematology, coagulation, and blood bank, including the T900 automatic chemistry analyzer.

LDN Labor Diagnostika Nord Germany • Nordhorn Tel: (49) 5921-8197-0 Web: ldn.de E-mail: info@ldn.de Develops and produces in vitro diagnostic test systems for the clinical and research laboratory markets.

Lee Company, The USA • Westbrook, CT Tel: (1) 860-399-6281 Web: theleeco.com Manufactures miniature fluid control components for automated liquid handling in medical and scientific instrumentation, analytical/clinical chemistry, and medical disposable applications.

Leica Microsystems

LifeSign USA • Skillman, NJ

Lifotronic Technology

and reagents covering clinical chemistry, serology, urinalysis, hematology and immunology. The company also offers clinical chemistry reagents, turbidimetry reagents, hematology VSG tubes, febrile antigens, ELISA reagents and lab equipment, as well as i-FOB products for gastroenterology applications.

Lobeck Medical

China • Shenzhen Tel: (86) 755-2906-0026 Web: lifotronic.com E-mail: inter-sales@lifotronic.com Specializes in development, manufacturing and marketing of bedside treatment and diagnostic products. Company products include a fast-growing IVD diagnostic product line with three major technology platforms, as well as items for wound management with lowlower laser therapy (LLLT).

Liofilchem Italy • Roseto, Abruzzo Tel: (39) 085-893-0745 Web: liofilchem.it Develops and manufactures a wide range of high-quality and reliable products for microbiology applications.

Linear Chemicals Spain • Barcelona Tel: (34) 934 694 990 Web: linear.es E-mail: info@linear.es Develops, manufactures, markets and sells IVD products including various instruments

Switzerland • Frick Tel: (41) 62-865-11-50 Web: lobeck.com E-mail: info@lobeck.com Manufactures products for the diabetic and IVD markets, including point-of-care tests.

Tel: (1) 858-546-0902 Web: lusyslab.com E-mail: onestep@lusyslab.com Manufactures products that test for cancer, birth defects, heart attacks, infectious and sexually transmitted diseases.

LW Scientific USA • Lawrenceville, GA Tel: (1) 800-726-7345 Web: lwscientific.com Supplies products to the laboratory market, including microscopes, centrifuges, and general lab equipment, for applications in hematology, pathology, cytology, and infectious diseases.

LP Italiana Italy • Milan Tel: (39) 02-3933-061 Web: lpitaliana.com E-mail: info@lpitaliana.com Develops, manufactures, and markets disposable products for clinical chemistry, hematology, serology, microbiology and bacteriology.

Luminex USA • Austin, TX Tel: (1) 512-219-8020 Web: luminexcorp.com Develops, manufactures, and markets biological testing technologies with applications throughout the life sciences and clinical diagnostics industry.

LuSys Laboratories USA • San Diego, CA

Maccura Biotechnology China • Chengdu Tel: (86) 028-8782-6777 Web: maccura.com E-mail: export@maccura.com Develops, produces, markets and distributes IVD products for applications in clinical biochemistry, chemiluminescent immunoassay, rapid diagnosis, thrombosis, hemostasis, and molecular diagnosis.

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Germany • Wetzlar Tel: (49) 64-41-29-4000 Web: leica-microsystems.com Manufactures and supplies optical solutions based on microscopes and related instruments

Tel: (1) 800-526-2125 Web: lifesignmed.com Provides point-of-care testing solutions for the detection of medical conditions and illnesses that include cardiac markers, infectious disease, women’s health, abused drugs, urinary tract infections, and GI disorders.

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Macherey-Nagel Germany • Düren Tel: (49) 2421-9690 Web: mn-net.com E-mail: sales@mn-net.com Develops, manufactures, and markets antibiotic test papers, photometers, and urine analyzers.

Magellan Biosciences USA • North Billerica, MA Tel: (1) 978-856-2345 Web: magellanbio.com Provides products that address the biomedical research and clinical diagnostics industries.

MagnaBioSciences

Magnasense Technologies Finland • Tampere Tel: (358) 40-5435-989 Web: magnasense.com E-mail: info@magnasense.com Manufacturer of a compact POC assay system based on antibodies labeled with paramagnetic particles that is easily integrated into labs and near patient settings.

Magnisense France • Rosny-sous-Bois Tel: (33) 01-4562-8000 Web: magnisense.com E-mail: contact@ magnisense.com Develops and markets magnetic immunoassays intended to improve rapid diagnostic performance for human and animal diagnostics.

Magnus Analytics India • New Delhi Tel: (91) 98-1043-1348 Web: magnusoptics.com LINKXPRESS COM

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Mast Group UK • Liverpool, Merseyside Tel: (44) 151-933-7277 Web: mastgrp.com E-mail: sales@mastgrp.com Manufactures and supplies IVD kits, reagents, and equipment for the clinical market with an emphasis on microbiology.

Master Diagnostica Spain • Granada Tel: (34) 958-271-449 Web: masterdiagnostica.com E-mail: master@vitroweb.com Develops, manufactures, and markets products for in vitro diagnosis of oncological and infectious diseases in the area of cellular and molecular pathology.

Maxcom Electronic China • Shenzhen Tel: (86) 0755-2650-4439 Web: maxcom.com.cn E-mail: sales@maxcomchina.com Designs diagnostic equipment such as automated hematology analyzers, as well as biochemistry analyzers.

Mayo Medical Laboratories USA • Rochester, MN Tel: (1) 507-266-5700 Web: mayomedicallaboratories.com E-mail: mmlglobal@mayo.edu Offers 3,000+ tests and provides access to Mayo Clinic physicians and scientists. As part of the Mayo Clinic’s Department of Laboratory Medicine and Pathology, the company performs tests for Mayo Clinic patients and provides reference testing for 4,000+ hospitals, clinics, and labs in more than 70 countries worldwide.

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USA • San Diego, CA Tel: (1) 858-481-4400 Web: magnabiosciences.com E-mail: info@ magnabiosciences.com Focuses on point-of-care testing and the development of assays for immunology.

E-mail: sales@ magnusanalytics.com Manufactures microscopes and microscope optics for the clinical laboratory market.

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MDS Nordion Canada • Ottawa, ON Tel: (1) 613-592-2790 Web: nordion.com E-mail: isotopeorders@ mdsinc.com Uses radiation technologies to prevent, diagnose, and treat disease. Two primary areas make up the business: nuclear medicine and ion technologies.

Medica Corporation USA • Bedford, MA Tel: (1) 781-275-4892 Web: medicacorp.com E-mail: sales@medicacorp.com Manufactures blood testing analyzers specifically designed for the low-volume in vitro diagnostic testing market. The electrolyte analyzers measure sodium, potassium, chloride, lithium, calcium and pH in whole blood, serum, plasma and urine. The blood gas analyzers measure PO2, PCO2 and pH and use a calibration method that eliminates gas tanks.

Medical Biological Union Russia • Novosibirsk Tel: (7) 383-363-7720 Web: mbunion.com E-mail: info@mbunion.com Manufactures and markets ELISA products for IVD of infectious diseases, along with performance sera panels for the quality control of kits imported and manufactured in Russia.

Medical Wire & Equipment UK • Corsham, Wiltshire Tel: (44) 1225-810361 Web: mwe.co.uk E-mail: info@mwe.co.uk Manufactures and distributes gel transport swabs, as well as liquid Amies medium with flock or foam swabs for clinical and industrial microbiology.

Medicon Greece • Athens Tel: (30) 210-6606000 Web: mediconsa.com Specializes in the R&D, production and export of diagnostic reagents, the production of laboratory information software, and the import and distribution of in vitro diagnostics and automated analytical systems.

Medix Biochemica Finland • Espoo Tel: (358) 9-547-680 Web: medixbiochemica.com E-mail: medix@ medixbiochemica.com Develops, produces and markets monoclonal antibodies, antibody services and recombinant antigens for the IVD industry, as well as diagnostic rapid tests for human healthcare worldwide.

Medsource Ozone Biomedicals India • Haryana Tel: (91) 129-4286-600 Web: ozonebio.com E-mail: mail@ozonebio.com Specializes in products and reagents for in vitro diagnostics, as well as clinical chemistry, POC testing, immunology, microscopy, hematology, coagulation, blood bank, pipettes, and liquid handling systems.

Melet Schloesing Laboratories France • Osny Tel: (33) 01-30-75-30-00 Web: mslabos.com E-mail: mslabos@mslabos.com Produces hematology cell counters and hematology reagents for the clinical lab.

Menarini, A., Diagnostics Italy • Florence Tel: (39) 55-56801 Web: menarini.com Focuses on the research and development of diagnostic drugs that target cardiovascular diseases, oncology, and pain/inflammation, asthma.

Mercedes Medical USA • Sarasota, FL Tel: (1) 800-331-2716 Web: mercedesmedical.com Specializes in offering histology supplies and equipment, clinical

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LabMedica 300 supplies, and lab equipment, along with supplies for toxicology, microbiology, healthcare education, and home health care.

Merck KGaA Operates as MilliporeSigma in the USA and Canada Germany • Darmstadt Tel: (49) 06151-3599-499 Web: sigmaaldrich.com E-mail: cssorders@sial.com Provides scientists and engineers with best-in-class lab materials, technologies and services, and offers a broad portfolio of 300,000 products and an expanded global footprint.

Meridian Bioscience USA • Cincinnati, OH Tel: (1) 513-271-3700 Web: meridianbioscience.com E-mail: mbi@meridianbioscience.com Develops, manufactures, and markets immunodiagnostic kits for the diagnosis of infectious diseases.

Meridian Life Science USA • Memphis, TN Tel: (1) 901-382-8716 Web: meridianlifescience.com E-mail: beatrice.deveyrac@ meridianlifescience.com Provides contract R&D, process development, and manufacturing of critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets.

Micro Lab Instruments India • Ahmedabad, Gujarat Tel: (91) 79-2658-5919 Web: microlab.co.in E-mail: info@microlab.co.in Manufactures versatile semi-auto chemistry analyzers; ISE-based electrolyte analyzers for Na/K/ iCa/ Cl; ELISA plate readers and automated plate washers; coagulation readers (single-channel and fourchannel); hematocrit capillary-based bilirubinometer for neonates; and dry bath incubators.

MicrobioLogics USA • St. Cloud, MN Phone: (1) 320-253-1640 Web: microbiologics.com Email: info@microbiologics.com Produces lyophilized microorganisms for quality control in microbiology laboratories worldwide. The company specializes in clinical, industrial, food quality, environmental and educational markets, and offers over 3,000 items in the product line with more than 500 different lyophilized microorganism strains.

Microlit India • Lucknow Tel: (91) 98390-14252 Web: microlit.com E-mail: ajayjain2801@gmail.com Manufactures and markets liquid handling products including micropipettes and pipette filling devices for a range of laboratory applications.

Mindray China • Shenzhen Tel: (86) 755-8188-8998 Web: mindray.com.cn E-mail: intl-market@mindray.com Specializes in the R&D and manufacture of clinical laboratory instruments and reagents that focus on patient monitoring devices, and diagnostic laboratory instruments for disease detection.

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Monlab Spain • Barcelona Tel: (34) 93-433-58-60 Web: monlab.com E-mail: pedidos@monlab.es Specializes in clinical laboratory services, and manufactures in vitro diagnostic products for clinical biochemistry and serology.

LabMedica International December/2017-January/2018

Moss USA • Pasadena, MD Tel: (1) 410-768-3442 Web: mosssubstrates.com E-mail: bmoss2@erols.com Produces liquid stable immunoassay reagents, including substrates and conjugates, used in diagnostic testing applications, as well as in research and process testing at pharmaceutical and biotechnology companies.

MP Biomedicals USA • Santa Ana, CA Tel: (1) 800-854-0530 Web: mpbio.com E-mail: custserv@mpbio.com Manufactures and sells a line of life science, fine chemical and diagnostic products. The company’s products range from specialized areas of research to supplying largescale quantities of fine chemicals.

MPW Med. Instruments Poland • Warsaw Tel: (48) 22-673-56-21 Web: mpw.pl E-mail: mpw@mpw.pl Develops and manufactures a wide range of medical and laboratory centrifuges including universal and special types, low- and high-speed, refrigerated or refrigerated and heated.

MYCO Instrumentation USA • Renton, WA Tel: (1) 253-447-4220 Web: myco-instrumentation.com E-Mail: info@ myco-instrumentation.com Provides clinical laboratory equipment, clinical chemistry analyzers, hematology analyzers, coagula-

tion analyzers, analytical lab equipment, biotechnology equipment, and diagnostic imaging equipment.

NanoEntek Korea • Seoul Tel: (82) 2-6220-7728 Web: nanoentek.com Specializes in the fields of biomedical engineering, bio-MEMS (Micro-Electro-Mechanical Systems), electronics, chemistry, and optics, and have developed innovative products for life science research and point-of-care diagnostics.

National Reference Laboratory UAE • Dubai Tel: (971) 800-675 Web: nrl.ae E-mail: blakinska@nrl.ae

In partnership with LabCorp, NRL offers a comprehensive menu of more than 4,700 tests, providing a complete solution for all clinical testing needs.

NG Biotech France • Guipry Tel: (33) 02-23-30-17-83 Web: ngbiotech.com E-mail: info@ngbiotech.com Specializes in research and development, manufacturing and marketing of telediagnostic products including quantitative and multiplex rapid test solutions, as well as laboratory bench readers, and

LabMedica 300 hand-held readers.

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SEE AD ON PAGE 13

immunodiagnostic assay manufacturers.

Nihon Kohden

Nordic Biomarker

Japan • Tokyo Tel: (81) 3-5996-8036 Web: nihonkohden.com Major product line for clinical diagnostics includes both automatic and semiautomatic hematology analyzers. The product range includes economical 2 parameter analyzers to fully automated 22 parameter analyzers with a barcode reader and a 50-sample rack.

Sweden • Umea Tel: (46) 90-71-86-01 Web: nordicbiomarker.com E-mail: marketing@ nordicbiomarker.com Specializes in the development and manufacturing of specialty coagulation assays.

Nikon Instruments USA • Melville, NY Tel: (1) 631-547-8500 Web: nikoninstruments.com E-mail: nikoninstruments@ nikon.net Designs, manufactures, and markets specialized optical lenses. Products include measuring microscopes, as well as biolaboratory, clinical microscopes.

Nittobo America

USA • Waltham, MA Tel: (1) 781-894-0800 Web: novabiomedical.com E-mail: info@novabiomedical.com Develops whole blood analyzers to support the care of critically ill patients. Product applications include usage in the central laboratory, emergency department, surgery, critical care area, or respiratory care area.

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USA • Murrieta, CA Tel: (1) 951-677-5629 Web: nittobous.com E-mail: sales@nittobous.com Comprised of manufacturing facilities for two respected brands of products: International Immunology Corporation and Midland BioProducts Corporation. The company is ISOcertified (9001:2015) for the design, manufacture and supply of bulk polyclonal antisera and complementary products, as well as the manufacturing and supply of products in bulk quantities as raw material to

Nova Biomedical

SEE AD ON PAGE 17

NovaTec Immundiagnostica Germany • Dietzenbach Tel: (49) 6074-4876-0 Web: novatec-id.com E-mail: info@novatec-id.com Develops and manufactures ELISA diagnostic kits with an emphasis on infectious diseases, allowing for the rapid diagnosis of bacterial, viral, and parasitic diseases.

NuAire USA • Plymouth, MN Tel: (1) 800-328-3352 Web: nuaire.com E-mail: nuaire@nuaire.com Manufactures biological safety cabinets, CO2 water-jacketed incubators, laminar air flow equipment, ultra-low temperature freezers, and complementary products and systems.

Nüve Turkey • Ankara Tel: (90) 312-399-2830 Web: nuve.com.tr E-mail: sales@nuve.com.tr Manufactures and distributes a wide range of laboratory equipment including incubators, deep freezers, dry heat sterilizers, ovens, centrifuges, water baths and water distillers, blood bank refrigerators, safety cabinets, and bench-top steam sterilizers.

Oasis Diagnostics

erance, autoimmune disease, and infectious disease.

Operon Spain • Cuarte de Huerva Tel: (34) 976-50-3597 Web: operon.es E-mail: sales@operon.es Manufactures and markets immuno and molecular in vitro diagnostic products including lateral flow tests, and molecular tests for clinical diagnostics.

OraSure Technologies USA • Bethlehem, PA Tel: (1) 610-882-1820 Web: orasure.com Develops, manufactures and markets oral fluid specimen collection devices, as well as diagnostic products including immunoassays and in vitro diagnostic tests.

Orgentec Diagnostika

USA • Vancouver, WA Tel: (1) 360-546-1563 Web: 4saliva.com E-mail: info@4saliva.com Manufactures saliva collection devices and test kits, as well as ELISA products for HIV, drugs of abuse, and steroid hormones.

Germany • Mainz Tel: (49) 6131-9258-0 Web: orgentec.com E-mail: orgentec@orgentec.com Focuses on the development and production of autoimmune ELISA test systems.

Omega Diagnostics

Finland • Espoo Tel: (358) 10-4261 Web: oriondiagnostica.fi Specializes in rapid and easyto-use clinical diagnostic and hygiene-monitoring products.

UK • Alva, Scotland Tel: (44) 1259-763-030 Web: omegadiagnostics.com E-mail: odl@omegadiagnostics.com.uk Develops and manufactures IVD products, specializing in the areas of allergy, food intol-

Orion Diagnostica

Orphee Medical Switzerland • Plan-les-Ouates Tel: (41) 22-884-90-90 Web: orphee-medical.com E-mail: contact@ orphee-medical.com Develops and markets instrumentation for the hematology diagnostic market, addressing the needs of small and midsized laboratories, as well as physician offices.

Ortho-Clinical Diagnostics USA • Rochester, NY Tel: (1) 800-828-6316 Web: orthoclinical.com Focuses on diagnostic products for donor screening, immunohematology, clinical chemistry, and immunodiagnostics.

Oyster Bay Pump Works USA • Hicksville, NY Tel: (1) 516-933-4500 Web: obpw.com E-mail: info@obpw.com Develops and manufactures equipment ranging from small precision tabletop liquid dispensers to fully integrated, multifunction systems on a variety of conveyor and robotic platforms. Applications include liquid handling, automation and systems integration.

Panasonic Netherlands • Etten Leur Tel: (31) 765-433-833 Web: eu.biomedical.panasonic-healthcare.com Specializes in products for lab conservation, incubation, and sterilization, along with offering a range of Biocision CoolProducts.

Paul Marienfeld Germany • LaudaKönigshofen LINKXPRESS COM

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Tel: (49) 0-9343-6270-0 Web: marienfeldsuperior.com E-mail: info@ marienfeld-superior.com Offers a comprehensive range of laboratory glassware including microscope slides, cover glass, counting chambers, capillary tubes, lab containers, and volumetric glassware.

Pentapharm Switzerland • Basel Tel: (41) 61 7064848 Web: pentapharm.com Specializes in research, development, and production of active ingredients for the pharmaceutical industry, as well as diagnostic products relating to hemostasis.

Peripheral Visions USA • Auburn, WA Tel: (1) 253-735-3910 Web: peripheralvisions.com E-mail: info@peripheralvisions.com Peripheral Visions manufactures and distributes clinical chemistry consumables and replacement parts for use on Hitachi/Roche, Beckman Coulter, Olympus and other analyzers. We develop and supply probes, electrodes, lamps, cuvettes, pump tubing, maintenance kits, stirrer paddles, disc drives, circuit boards and many other products under our Perphormax™ brand. We also offer an extensive line of service and replacement parts to keep analyzers operational. We also custom manufacture for OEM's.

PerkinElmer USA • Waltham, MA Tel: (1) 203-925-4602 Web: perkinelmer.com E-mail: customercareus@ perkinelmer.com Provides scientific instruments, consumables and services to the pharmaceutical, biomedical, environmental testing and general industrial markets. Designs and manufactures systems for the life, analytical, and optoelectronics markets.

Perlong Medical Equipment

reagents for clinical chemistry and hematology, as well as POC tests for FOBT, cholesterol, diabetes, and bladder cancer detection.

Porex USA • Fairburn, GA Tel: (1) 770-964-1421 Web: porex.com E-mail: info@porex.com Develops and manufactures advanced porous plastic materials, porous PTFE, glass fiber, porous polymer fiber, certified Pure Porex media and functionalized and bio-activated porous materials. The products serve the healthcare and bioscience end markets for use in clinical science, liquid handling, molecular and microfluidic diagnostic applications.

Prokan Electronics China • Shenzhen Tel: (86) 755-2674-7910-807 Web: procanmed.com E-mail: info@procanmed.com Develops, manufactures, and services medical testing instruments, as well as offers a series of hematology analyzers.

ProteomeTech Korea • Seoul Tel: (82) 2-323-8343 Web: proteometech.com E-mail: protia@proteometech.com Conducts research on protein translation and modification in the proteome level so that proteins that are directly related to diseases can be found to protect and detect diseases beforehand.

Puritan Medical Products USA • Guilford, ME Tel: (1) 207-876-3311 Web: puritanmedproducts.com E-mail: sales@ puritanmedproducts.com Manufactures specialty and single-use products for medical and diagnostic applications, including swabs and tipped applicators.

Qiagen

China • Nanjing Tel: (86) 25-8718-7780 Web: perlong.com E-mail: overseas@perlong.com.cn Provides products that include clinical laboratory equipment and reagents, surgical equipment and blood analytic equipment, and X-ray video devices.

Pointe Scientific / MedTest USA • Canton, MI Tel: (1) 734-487-8300 Web: medtest.com E-mail: marketing@medtest.com Offers Pointe Scientific, MedTest DX, and Clinitox Diagnostix brand products to the clinical diagnostics industry. Products include analyzers, reagents, calibrators and standards, controls, and solutions for diabetes, cardiovascular disease, lipid, renal, hepatic and more.

Polymedco USA • Cortlandt Manor, NY Tel: (1) 914-739-5400 Web: polymedco.com Provides instruments and

Germany • Hilden Tel: (49) 2-103-29-12000 Web: qiagen.com E-mail: qiagen@qiagen.com Specializes in sample and assay technologies used to isolate and process DNA, RNA, and proteins from biological samples such as blood or tissue.

Quantimetrix USA • Redondo Beach, CA Tel: (1) 310-536-0006 Web: quantimetrix.com E-mail: sales@quantimetrix.com Designs, develops and manufactures a specialized portfolio of quality control products and OEM services that improve the efficiency and reliability of laboratory testing and patient care.

Quidel USA • San Diego, CA Tel: (1) 858-552-1100 Web: quidel.com E-mail: custserv@quidel.com Develops, manufactures and markets rapid diagnostic tests at the point-of-care (POC) that focus on infectious diseases and reproductive health.

LabMedica International December/2017-January/2018

LabMedica 300 Quimica Clinica Aplicada

Robonik India

SA Scientific

Spain • Tarragona Tel: (34) 977-706-230 Web: qca.es E-mail: export@qca.es Manufactures IVD reagents for use in biochemistry, immunology, hemostasis, microbiology, histopathology, and hematology applications.

India • Mumbai, Maharashtra Tel: (91) 22-6782-9700 Web: robonik.in E-mail: export@ robonikindia.com Designs and manufactures diagnostic instruments intended to meet a wide spectrum of user requirements including a variety of analyzers and ELISA plate readers and washers, as well as urine analyzers and reagents.

USA • San Antonio, TX Tel: (1) 210-699-8800 Web: sascientific.com E-mail: sales@sascientific.com Focuses on rapid diagnostic tests for infectious and bacterial diseases, as well as food microbiology, veterinary testing, and environmental testing.

R-Biopharm Germany • Darmstadt Tel: (49) 6151-8102-0 Web: r-biopharm.com E-mail: info@r-biopharm.de Develops, produces and markets enzyme immunoassays for the detection of human infectious diseases. The product line contains test systems in the field of stool diagnostics, infectious disease, serology, and allergy testing.

Radiometer Medical Denmark • Bronshoj Tel: (45) 38-27-38-27 Web: radiometer.com E-mail: radiometer@radiometer.dk Products include blood gas analyzers; combined blood gas electrolyte, metabolite and oximetry analyzers; transcutaneous blood gas monitors.

RAL Técnica para el Laboratorio Spain • Barcelona Tel: (34) 93 480 80 47 Web: ral-sa.com E-mail: comercial@ral-sa.com Offers service to the clinical chemistry diagnostic field, focusing on the in vitro diagnostic field.

Randox Laboratories UK • Crumlin Tel: (44) 0-28-9442-2413 Web: randox.com E-mail: marketing@randox.com Specializes in diagnostic reagents and equipment for laboratory medicine. Products include Biochip Array Technology, clinical chemistry automation systems, quality control materials, external quality assurance schemes, clinical reagents, and environmental diagnostics.

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Rayto Life and Analytical Sciences China • Shenzhen Tel: (86) 755-8883-2350 Web: rayto.com E-mail: info@rayto.com Develops, manufactures, markets and services clinical laboratory instruments and reagents. The company’s product range comprises chemistry analyzers, microplate readers, microplate washers, and coagulation analyzers.

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Reagena Finland • Toivala Tel: (358) 10-5045-200 Web: reagena.com E-mail: info@reagena.com Focuses on areas of point-of-care diagnostics of infectious disease and immunity. Products include the development of ready-to-use test kits for POC and lab medicine.

RNA Medical USA • Devens, MA Tel: (1) 978-772-9070 Web: rnamedical.com E-mail: rnasales@rnamedical.com Supplies quality control materials and related products for blood gas, critical blood analyte, and diabetes care applications. The product line includes daily QC materials, calibration verification and linearity products, and glass capillary blood collection tubes.

LabMedica International December/2017-January/2018

Roche Diagnostics Switzerland • Basel Tel: (41) 61-688-1111 Web: roche.com Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests.

Sakura Finetek Europe Netherlands • Alphen aan den Rijn Tel: (31) 88-592-00-00 Web: sakuraeu.com E-mail: sakura@sakura.eu Manufactures products with a focus on tissue samplers and processors, as well as automated slide stainers and coverslippers. Brands offered include Tissue-

Tek, Cyto-Tek and Accu-Edge.

Salimetrics USA • State College, PA Tel: (1) 814-234-7748 Web: salimetrics.com Provide researchers, analytical and functional testing laboratories, and the immunodiagnostic industry with innovative salivary immunoassay products and services.

Samsung Korea • Seoul Tel: (82) 2-2194-1000 Web: samsungmedison.com Develops, manufactures, and markets diagnostic products and solutions for IVD and point-of-care applications.

Sanovo Biotech Denmark • Odense

Tel: (45) 6611-1732 Web: sanovobiotech.com E-mail: salessuppport@ sanovobiotech.com Specializes in R&D of high-affinity polyclonal avian antibodies for scientific research and diagnostics industries. Provides customers with readymade and customized antibody products in bulk and in research quantities.

Sanquin Reagents Netherlands • Amsterdam Tel: (31) 20-512-30-00 Web: sanquinreagents.com E-mail: reagents@sanquin.nl Provides blood supplies and promotes transfusion medicine. The company has also developed a range of reagents, including several products for diagnostic use and for fundamental and clinical

LabMedica 300 research.

Sarstedt Germany • Nümbrecht Tel: (49) 2293-3050 Web: sarstedt.com E-mail: info@sarstedt.com Develops, manufactures, and sells consumables and analytical equipment for medical diagnostics, as well as consumables, laboratory aids, and laboratory equipment for industrial and research laboratories.

Savyon Diagnostics

Sebia

Sciex USA • Framingham, MA Tel: (1) 877-740-2129 Web: absciex.com E-mail: support@absciex.com Develops scientific instrumentation, software, and services used to advance science in the fields of basic research, drug discovery & development, food & environmental testing, forensics and clinical research.

SD Biosensor

Sentinel Diagnostics Italy • Milan Tel: (39) 0-2-3455-141 Web: sentineldiagnostics.com E-mail: sentinel@sentinel.it Develops and supplies in vitro diagnostic reagents for clinical laboratories.

Serosep Ireland • Annacoty, Co. Limerick Tel: (353) 61-358-190 Web: serosep.com E-mail: info@serosep.com Distributes a range of laboratory diagnostic products for clinical and environmental labs.

SEE AD ON PAGE 47

Siemens Healthineers USA • Tarrytown, NY Tel: (1) 914-631-8000 Web: siemens.com/diagnostics Offers a broad spectrum of immunoassay, chemistry, hematology, molecular, urinalysis, and blood gas testing systems, along with automation, informatics, and services that can serve the needs of labs of any size today and tomorrow. SEE AD ON PAGE 5

Skannex

Shenzhen New Industries Biomedical Engineering (SNIBE) China • Shenzhen Tel: (86) 755-2650-1514 Web: snibe.com E-mail: sales@snibe.com Specializes in clinical laboratory instruments and IVD reagents including the production of nano magnetic microbead products, automated CLIA systems, analyzers and matched reagent kits, and magnetic enzyme immunoassay analyzers and matched reagent kits. SEE AD ON PAGE 3, 15

Sinnowa China • Nanjing Tel: (86) 025-8412-7188 Web: sinnowa.com E-mail: info@sinnowa.com Specializes in researching, developing and manufacturing clinical laboratory equipment and reagents. The company has developed fully automatic clinical chemistry analyzers, coagulometers, microplate readers, and diagnostic reagents.

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Korea • Suwon Tel: (82) 31-300-0400 Web: sdbiosensor.com E-mail: sales@sdbiosensor.com

SEE AD ON PAGE 19

France • Saint Jean d’Illac Tel: (33) 0-5-56-68-80-50 Web: sfri.com E-mail: contact@sfri.com Manufactures and exports in vitro diagnostic instruments and reagents, specializing in human biological analysis and concentrating on routine clinical testing in the hematology, biochemistry, and immunology sectors.

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USA • Dover, NJ Tel: (1) 862-254-0405 Web: scimedx.com E-mail: dcrosby@scimedx.com Specializes in immunofluorescence, rapid, and ELISA technologies for a wide variety of unique and routine autoimmune, parasitic and infectious diseases, as well as particle agglutination, column chromatography and fractionation and conjugation of sera.

USA • Lexington, MA Tel: (1) 781-652-7800 Web: sekisuidiagnostics.com E-mail: questions@sekisuidx.com Develops, manufactures, and supplies clinical chemistry and coagulation systems, as well as reagents, infectious disease rapid tests, LINE immunoassays, ELISA kits, enzymes, and specialty bio-chemicals.

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Scimedx

Sekisui Diagnostics

SFRI

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France • Evry Tel: (33) 1-6989-8080 Web: sebia.com E-mail: sebia@sebia.com Specializes in the design and development of instruments and assays for electrophoresis. Products include automated capillary electrophoresis instruments, carbohydrate-deficient transferrin, high-resolution capillary electrophoresis and hemoglobin assays.

Specializes in the development, production and sale of antibody-based tests to guide disease management.

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Israel • Ashdod Tel: (972) 8-8562920 Web: savyondx.com E-mail: info@ savyondx.com Develops, manufactures, and markets diagnostic kits for the detection of infectious diseases and genetic screening.

Manufactures in vitro diagnostic systems used in POC, hospitals, and central labs. Products include HbA1c analyzers, cholesterol analyzers, and blood glucose monitoring systems, as well as rapid tests for infectious diseases.

SEE AD ON PAGE 40

Norway • Oslo Tel: (47) 9925-2274 Web: skannex.com E-mail: bent@skannex.com Develops, manufactures, and markets software for image recognition, capturing, and analysis of bioassays, within the field of clinical diagnostics.

Slamed Germany • Frankfurt Tel: (49) 69-596-3964 Web: slamed.de E-mail: slamed-frankfurt@tonline.de Produces easy-to-operate, reliable devices for medical and biochemical laboratories.

SLR Research USA • Carlsbad, CA Tel: (1) 760-930-9496 Web: SLRresearch.com E-mail: slr@slrresearch.com Supplies a broad range of essential biological-based, bulk human disease-state and normal sera, specialty/esoteric antibodies, controls/calibrators and the IRB Clinical Specimen Repository.

SM Diagnostics India • Chennai Tel: (91) 44-2374-5508 Web: smdiag.net E-mail: expcustomersupport@ smdiag.net Designs and markets diagnostic instruments and reagents, including products for semiautomatic coagulation analysis, and sodium potassium analysis.

Socorex Switzerland • Ecublens Tel: (41) 21-651-6000 Web: socorex.com E-mail: socorex@socorex.com Designs and manufactures liquid handling instruments including manual and electronic micropipettes, multichannel pipettes, repeater pipettes, dispensers, pipette controllers, automatic and reusable syringes, pipette tips, and accessories.

Span Divergent India • Surat, Gujarat Tel: (91) 261-227-7211 Web: span.in E-mail: contact@span.in Focuses on research, development, and manufacturing of in vitro diagnostic and POC products.

Spectral Diagnostics Canada • Toronto, ON Tel: (1) 416-626-3233 Web: spectraldx.com E-mail: info@spectraldx.com LINKXPRESS COM

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Spinreact Spain • St. Esteve d'en Bas (Girona) Tel: (34) 972-690-800 Web: spinreact.com E-mail: spinreact@spinreact.com Develops and manufactures in vitro diagnostic reagents. Product applications include serology, clinical biochemistry, immunochemistry, rapid tests, blood grouping, coagulation, electrophoresis, and diagnostic instruments.

SPOT Imaging Solutions USA • Sterling Heights, MI Tel: (1) 586-731-6000 Web: spotimaging.com E-mail: info@spotimaging.com Designs and manufactures imaging systems for pathology applications, including scientific-grade digital cameras for microscopes.

SSI Diagnostica Denmark • Copenhagen Tel: (45) 3268-3268 Web: ssi.dk E-mail: serum@ssi.dk Specializes in the research and production of products that address infectious diseases and congenital disorders.

StatLab USA • McKinney, TX Tel: (1) 972-436-1010 Web: statlab.com E-mail: info@statlab.com Specializes in providing histology, cytology and other consumable supplies to more than 3,000 anatomic pathology laboratories throughout the United States.

Sunostik Medical Technology China • Changchun Tel: (86) 431-8465-0222 Web: sunostik.com E-mail: itd@sunostik.com Specializes in researching, manufacturing, and marketing biochemical analyzers, coagulators, diagnostic reagents, and microwave therapeutic machines.

Sunquest Information Systems USA • Tucson, AZ Tel: (1) 520-570-2000 Web: sunquestinfo.com E-mail: sales@sunquestinfo.com Focuses on laboratory information and solutions specifically designed for general laboratory, pathology, blood bank, microbiology, molecular, and other specialty areas in the clinical diagnostic field.

Super Brush USA • Springfield, MA Tel: (1) 413-543-1442 Web: superbrush.com E-mail: dhenry@superbrush.com Specializes in the design, development, and manufacturing of 3000+ styles of foam swabs for POC sample collection, material application and precision cleaning.

SurModics USA • Eden Prairie, MN Tel: (1) 952-500-7000 Web: surmodics.com Develops reagents and applications for the biomedical research and diagnostic markets. The company provides highsensitivity substrate chemistries and various diagnostic applications involving high-sensitivity chromogen substrates (colored chemical markers).

Sysmex

STRATEC Biomedical Germany • Birkenfeld Tel: (49) 7082-7916-0 Web: stratec.com E-mail: info@stratec.com Develops and manufactures reagents and kits for DNA/RNA stabilization, extraction, and purification using manual and automated systems.

Streck

Germany • Norderstedt Tel: (49) 40-534-10-20 Web: sysmex.de E-mail: info@sysmex.de Distributes and supports automated in vitro diagnostic hematology, coagulation and urinalysis analyzers, reagents, and information systems for laboratories and healthcare facilities.

Taigen Bioscience

USA • Omaha, NE Tel: (1) 800-843-0912 Web: streck.com E-mail: international@streck.com Manufactures hematology, chemistry, and immunology products. The company is considered an innovator of hematology control products, having developed some of the first hematology reference controls and has since developed additional control products for automated instruments.

Taiwan • Taipei City Tel: (886) 2-2889-1136 Web: labturbo.com E-mail: order@taigen.com Specializes in the development and manufacture of fully automated DNA/RNA extraction and qPCR instruments and reagents. The LabTurbo systems and kits are designed for fast, fully automated and precise molecular diagnostics and applications in various fields with versatile functions.

Sugentech

Tecan

Korea • Deajeon Tel: (82) 42-364-5000 Web: sugentech.com E-mail: info@sugentech.com Manufactures next-generation products for IVD applications including personal POCT products, mobile healthcare products, and personalized diagnosis/treatment solutions based on biotechnology, information technology, and nanotechnology.

Switzerland • Männedorf Tel: (41) 44-922-81-11 Web: tecan.com E-mail: info@tecan.com Specializes in the development, production, distribution and servicing of solutions for the discovery of pharmaceutical substances, as well as genomics, proteomics and diagnostics. The company develops measurement, analysis, and laboratory automation instruments.

LabMedica International December/2017-January/2018

LabMedica 300 Teco Diagnostics

Web: thermofisher.com Provides analytical instrumentation, lab equipment, automation technologies, reagents and consumables, and LIMS solutions to determine disease markers or analytes of diagnostics interest.

Titertek-Berthold Germany • Pforzheim Tel: (49) 7231-92-060 Web: titertek-berthold.com E-mail: contact@ titertek-berthold.com Develops, manufactures, and distributes high-performance instruments for life science labs, including easy-to-use instruments for biomedical, pharmaceutical, biotechnological, and fundamental research communities.

Tecom Science China • Nanchang Tel: (86) 791-8811-0293 Web: tecom-cn.com E-mail: sales@tecom-cn.com Develops and manufactures in vitro diagnostic reagents, as well as high tech medical equipment, including biochemistry analyzers.

Telstar Technologies

France • Croissy-Beaubourg Tel: (33) 1-64-62-10-12 Web: theradiag.com E-mail: info@theradiag.com Develops, manufactures and distributes in vitro diagnostic tests, as well as theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. The company markets the Lisa Tracker range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies.

Tokyo Boeki

Trinity Biotech

Toyobo Japan • Osaka Tel: (81) 6-6348-3111 Web: toyobo.co.jp Manufactures biopharmaceuticals using genetically engineered animal cells, specializing in cell culture technology, usable protein refinement and genetic and cell engineering. Currently, the company is focusing on genome drug discovT

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USA • Grass Valley, CA Tel: (1) 530-273-8888 Web: tricontinent.com E-mail: liquidhandling@ tricontinent.com Manufactures subsystems for clinical and biotechnology automated instruments.

USA • San Diego, CA Tel: (1) 858-546-0004 Web: www.trilinkbiotech.com E-mail: info@trilinkbiotech.com Manufactures custom oligonucleotides, modified nucleoside triphosphates and CleanAmp PCR products for the diagnostic market.

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TriContinent

Turkey • Ankara Tel: (90) 312-395-6009 Web: tokra.com.tr E-mail: info@tokra.com.tr Manufactures semiautomatic coagulation analyzers, as well as diagnostic instruments for hemostasis, clinical chemistry, cytogenetics, genetics, research and molecular biology.

Japan • Tokyo Tel: (81) 3-5427-5118 Web: tosoh.com Provides in vitro diagnostic analyzers, products and services for Immunoassay and HPLC applications.

USA • Waltham, MA Tel: (1) 781-622-1000

France • Alençon Tel: (33) 2-33-27-56-25 Web: vedalab.com Offers a range of rapid immunodiagnostic products for professional, home use and pointof-care (POC) testing. The company supplies fertility, infectious disease, drugs of abuse, tumor marker, cardiac marker and specializes in syphilis, tuberculosis, malaria and hepatitis tests.

Switzerland • Degersheim Tel: (41) 71-372-55-55 Web: treff-ag.ch E-mail: m.haas@treff-ag.ch Manufactures medical plastic components, medical devices, and plastic consumables.

TriLink BioTechnologies

Tosoh Bioscience

Thermo Fisher Scientific

Treff

Tokra Medikal

Japan • Tokyo Tel: (81) 3-3555-7211 Web: tokyo-boeki.co.jp Develops and markets a multifunction, small-sized automatic biochemical analyzer that is capable of processing 240 tests an hour.

Theradiag

ELISA kits and clinical chemistry reagents for public health.

LabMedica International December/2017-January/2018

Ireland • Bray, Co. Wicklow Tel: (353) 1-276-9800 Web: trinitybiotech.com E-mail: info@trinitybiotech.com Specializes in the development, manufacture, and marketing of products for point-ofcare (POC) and the clinical laboratory. The test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases.

Veda.Lab

Vicotex Switzerland • Pully Tel: (41) 21-728-4286 Web: vicotex.com E-mail: contact@vicotex.com Specializes in the production of hospital and laboratory equipment, including products for central sterilization.

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Spain • Terrassa Tel: (34) 937-361-600 Web: telstar.eu Designs and manufactures laboratory equipment for R&D, quality control, and analysis in sectors related to life and health sciences. Products available include vertical and horizontal laminar flow benches, biosafety cabinets, lyophilizers, containment and sterile isolators, and ultrafreezers.

ery support and contract manufacturing of therapeutic antibodies.

SEE AD ON PAGE 48

Vircell Spain • Granada Tel: (34) 958-44-12-64 Web: vircell.com E-mail: info@vircell.com Develops, manufactures and markets ready-to-use kits for the diagnosis of human infec-

tious diseases. The company specializes in R&D and offers complete diagnostic solutions for techniques including CLIA Monotest, ELISA, IFA, DFA, rapid tests, PCR controls and other unique in-house developments.

▲

USA • Anaheim, CA Tel: (1) 714-463-1111 Web: tecodiagnostics.com E-mail: hello@tecodiagnostics.com Teco Diagnostics manufactures a range of products including urine reagent strips, clinical chemistry reagents, rapid tests, serology latex kits, ELISA, instruments, and blood glucose devices.

SEE AD ON PAGE 49

Vitro Spain • Madrid Tel: (34) 91-382-16-20 Web: vitroweb.com E-mail: vitro@vitroweb.com Specializes in products including reagents and intelligent analysis software for application in flow cytometry, FISH probes for detecting nonrandom chromosomal abnormalities, software applications for pathology and PCR kits for HPV and lymphomas.

Voxtur Bio India • Mumbai Tel: (91) 261-246-3777 Web: voxturbio.com E-mail: contact@voxturbio.com Manufactures rapid test kits, blood grouping sera, latex test kits, febrile antigen reagents, ELISA test kits, blood collection tubes and lab plastic consumables.

W.H.P.M. USA • Irwindale, CA Tel: (1) 626-443-8480 Web: whpm.com E-mail: info@whpm.com Focuses on the research and development of one-step rapid membrane tests. Also, with sister company W.H.P.M. Biore-

Tyson Bioresearch Taiwan • Chunan Tel: (886) 37-585988 Web: tysonbio.com E-mail: sales_int@tysonbio.com Specializes in advanced rapid in vitro immunodiagnostic test systems, including blood glucose monitoring systems for everyday use, and electrical biosensing systems.

Unitma Korea • Seoul Tel: (82) 2-420-0070 Web: unitma.com E-mail: unitma@unitma.com Develops manual and fully automated tissue microarrayers, as well as paraffin block trimmers, for various lab applications.

URIT Medical China • Guilin, Guangxi Tel: (86) 773-2260-555 Web: uritest.com E-mail: chensha@uritest.com.cn Manufactures urine analyzers and reagent strips. The product range has expanded from single urine analyzers to multistructure urine analyzers, hematology analyzers, as well as biochemistry analyzers.

Vector-Best Russia • Novosibirsk Tel: (7) 383-3326-749 Web: vector-best.ru E-mail: vbmarket@vector-best.ru Focuses on the research, development, and manufacture of LINKXPRESS COM

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search Technology Co., Ltd., W.H.P.M. has researched, developed, and produced rapid test systems that include current product Hemosure.

Wako Japan • Osaka Tel: (81) 6-6203-3741 Web: wako-chem.co.jp/english Develops and manufactures products for three areas: laboratory chemicals, specialty chemicals, and diagnostic reagents.

Wama Diagnostica Brazil • São Carlos Tel: (55) 16-3377-9977 Web: wamadiagnostica.com.br Focuses on providing the clinical chemistry industry with products for extensive laboratory test procedures with products for rapid tests, pharmaceutical, latex, hemagglutination, immunofluorescence, and ELISA testing.

Waters USA • Milford, MA Tel: (1) 508-478-2000 Web: waters.com E-mail: customerservice@waters.com Designs, manufactures, sells and services ultra performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry (MS) systems, thermal analysis and rheometry instruments.

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Wilmad-LabGlass

equipment and specialty glass apparatus. Products include containers and vial products from both Type I borosilicate glass and Type III soda lime glass, plastic resins, the BOD (Biological Oxygen Demand) bottle, glass scintillation vials and a variety of glass and plastic rigid containers and closures.

Germany • Oberhausen Tel: (49) 208-305-505-0 Web: webers.de E-mail: info@webers.de Specializes in the field of blood gas and offers plastic end-toend capillaries, plastic heparinized blood gas capillaries and syringes, and capillary blood collection systems.

West Medica

USA • Vineland, NJ Tel: (1) 856-691-3200 Web: wilmad-labglass.com E-mail: cs@wilmad-labglass.com Manufactures NMR and EPR sample tubes and accessories, as well as precision-engineered glass, OEM quartz components and assemblies.

Wiener Laboratorios

Austria • Vienna Tel: (43) 1-804-81-84 Web: westmedica.com E-mail: vienna@westmedica.com Designs equipment for laboratory research and microscopy.

WLD-TEC Germany • Gottingen Tel: (49) 551-793-789 Web: wld-tec.com E-mail: sales@wld-tec.com Specializes in stationary and mobile safety laboratory gas burners, as well as electrical sterilization systems, and a wide range of available accessories.

Argentina • Rosario Tel: (54) 341-432-9191 Web: wiener-lab.com.ar E-mail: servicioalcliente@ wiener-lab.com Develops, manufactures and markets diagnostic reagents. Products are intended for clinical chemistry, specialized hospital laboratories, as well as for blood banks. Applications include in vitro diagnostic reagent kits for use in clinical chemistry and coagulation.

Wheaton Science Products USA • Millville, NJ Tel: (1) 856-825-1100 Web: wheatonsci.com Manufactures and markets laboratory instruments and equipment, liquid handling

Wondfo Biotech China • Guangzhou Tel: (86) 20-3229-6089 Web: wondfo.com.cn

RS UTO LY RIB O APP T S DI ED T IT INV

Worthington Biochemical USA • Lakewood, NJ Tel: (1) 732-942-1660 Web: worthingtonbiochem.com E-mail: custservice@worthington-biochem.com Produces purified enzymes, proteins, nucleic acids and related biochemicals for cell biology, biochemistry, protein and DNA/RNA applications. The company also produces collagenases, nucleases and other proteases and use-tested kits for the isolation of primary cardiomyocytes, neurons and hepatocytes. Animal-origin FREE collagenases, RNases, DNases and proteases are available for stem cell and biopharmaceutical applications.

Yashraj Biotechnology India • Mumbai Tel: (91) 22-2768-1949 Web: yashraj.com E-mail: marketing@yashrajbio.com Manufactures and supplies human native and recombinant antigens (Cardiac markers, infectious markers, Tumor mark-

THERMO RESISTANT GLOVES Up to 37 cm in length

ers, Renal markers, inflammation markers and others) like D-Dimer, NGAL, rSLO, RBP, MPO,FABP3, Prolactin etc., for controls and calibrators, and coating agents. The company also offers OEM services on the products as per the requirements / specifications.

YD Diagnostics Korea • Gyeonggi-do Tel: (82) 31-329-2011 Web: yd-diagnostics.com E-mail: admin@yd-diagnostics.com Develops, manufactures, and distributes diagnostic products for liquid-based cytology, MDx, and urinalysis. Products available include processors, fully automated systems, rapid tests, strips, and chemistry reagents.

YHLO Biotech China • Shenzhen Tel: (86) 755-2647-3359-8151 Web: szyhlo.com E-mail: marketing@szyhlo.com Specializes in developing, manufacturing, and distributing in vitro diagnostic instruments and reagents.

Zer Hitech Israel • Jerusalem Tel: (972) 2-995-5550 Web: zerhitech.com E-mail: contactus@zerhitech.com Develops, manufactures, and markets a wide range of one step, rapid, and Elisa diagnostic tests.

Zinsser Analytic Germany • Frankfurt Tel: (49) 69-78-91-06-0 Web: zinsser-analytic.com E-mail: info@zinsser-analytic.com Develops, manufactures, and markets laboratory solutions for liquid handling and automation, including high quality vials and scintillators, as well as systems for drug discovery, material science, and combinatorial chemistry.

Zivak Technologies Turkey • Istanbul Tel: (90) 212-210-6215 Web: zivak.com E-mail: info@zivak.com Provides ready-to-use LCMS/MS and HPLC analysis kits to the clinical diagnostic field. The company also supplies its own fully automated sample preparation and injection system, which allows labs to make efficient use of their LC-MS/MS and HPLC instruments in a fast, accurate, and cost-effective way

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E-mail: customerservice@ wondfo.com.cn Manufactures medical diagnostic testing kits, as well as biochemical reagents. The company focuses on labeling techniques with automated procedures for water purgation, cell cultivation, purity analysis, packaging, and sorting and testing.

SEE AD ON PAGE 27

Zytomed Systems Germany • Berlin Tel: (49) 30-804-984-990 Web: zytomed-systems.com E-mail: info@zytomed-systems.de Develops, produces, and distributes antibodies and detection systems for diagnostics and research applications.

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P O R T A L

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Calbiotech Carolina Liquid Chemistries Cepheid Chembio Diagnostic Systems Clinical Diagnostics Copan Diagnostics Corgenix CTK Biotech Diagnostic Automation Diamedix Diamond Diagnostics Diazyme Laboratories DRG International Drucker Diagnostics Dynex Technologies EastCoast Bio EMD Millipore Eurotrol Express Diagnostics International Fluid Metering Focus Diagnostics Fujirebio Diagnostics GenMark Diagnostics Globe Scientific Helena Laboratories Helmer HEMCO HemoCue Hemosure Hologic Hycor Biomedical IBL-America Immucor Gamma

136 – 144 112 133 137 108 135 104 152 – 141 139 142 110 106 138 132 131 146 134 102 107 109

77 Elektronika . . . . . . . . . . . .36 AACC . . . . . . . . . . . . . . . . . . .45 Alcor . . . . . . . . . . . . . . . . . . . .44 Atlas Link . . . . . . . . . . . . . . . .14 Biofire . . . . . . . . . . . . . . . . . . .33 Biohit . . . . . . . . . . . . . . . . . . .37 Boule . . . . . . . . . . . . . . . . . . . .8 Brand . . . . . . . . . . . . . . . . . . .35 Caretium . . . . . . . . . . . . . . . . .37 Cellavision . . . . . . . . . . . . . . .52 CMEF 2018 . . . . . . . . . . . . . .43 Denka Seiken . . . . . . . . . . . . .41 Diagnostica Stago . . . . . . . . .39 Diagon . . . . . . . . . . . . . . . . . .42 Diasource . . . . . . . . . . . . . . . .10 DiaSys . . . . . . . . . . . . . . . . . . .6 DRG . . . . . . . . . . . . . . . . . . . .38 Drucker . . . . . . . . . . . . . . . . . .32 DxGen . . . . . . . . . . . . . . . . . .31 Dymind . . . . . . . . . . . . . . . . . .46 EKF . . . . . . . . . . . . . . . . . . . .34 ELITech Group . . . . . . . . . . . . .2 Erba . . . . . . . . . . . . . . . . . . . . .7 Erba . . . . . . . . . . . . . . . . . . . . .9

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