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Annual Review 2015

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Year’s Top 100 Clinical Developments . . . . . . . . . . . . . . . . . . . . . . 6 Year’s Top 10 Industry News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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TOP 100 NEWS DEVELOPMENTS OF 2015 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 New-Identified Gene Drives Triple-Negative Breast Cancer novel gene has been discovered that when mutated, can drive development and progression of triple-negative breast cancer. A team of scientists assessed alterations to genes that influence the actions of stem cells and developing tissues, as past studies from the team has indicated that these alterations affect cancer development. By assessing these gene alterations among breast cancer cells from patients, the team found that a gene called B-cell lymphoma/leukemia 11A (BCL11A) was particularly active in triple-negative

breast cancer. Increased BCL11A activity was identified in around 8 out of 10 basal-like breast cancers and was associated with more aggressive tumors. The study was published on January 9, 2015, in the journal Nature Communications.

Neglected Malaria Subspecies Characterized By Novel Molecular Assay lasmodium ovale subspecies are similar based on morphology and geographical distribution, but allelic differences indicate that P. ovale curtisi and P. ovale wallikeri are genetically divergent. In the study scientists identified twenty-two samples as positive

for P. ovale. Alignments of tryptophan-rich antigen (tra) gene sequences revealed nine samples (40.9%) positive for P. ovale curtisi type 1, two samples (9.1%) positive for P. ovale curtisi type 2, six samples (27.3%) positive for P. ovale wallikeri type 1, and three samples (13.6%) positive for P. ovale wallikeri type 2. The investigators concluded that their P. ovale rbp2 qPCR assay detects P. ovale curtisi and P. ovale wallikeri simultaneously and can be utilized to characterize P. ovale in malaria endemic regions. The study was published on January 15, 2015, in the journal PLOS Neglected Tropical Diseases.

4 New Biomarkers Identified For Cardiovascular Risk lood screening technology has uncovered four new biomarkers that improve the prediction of the risk for heart attack or stroke within 15 years. Scientists looked for measures in the blood that could reflect a heart attack or a stroke within the following years. Four biomarkers were indicative of future cardiovascular disease risk independently of known risk factors. The biomarkers for future cardiovascular disease were phenylalanine and the amount of monounsaturated fat in the blood. Higher blood levels of both omega-3 and omega-6 fatty acids were linked with lower risk for cardiovascular disease. All these molecules are normally present in everyone’s blood, but it is the amount of these molecules that was shown to be reflecting cardiovascular health. The study was published on January 8, 2015, in the journal Circulation.

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Mutated Gene Biomarker Identified For Rare Adrenal Tumors gene mutation has been found that may serve as a biomarker for rare adrenal tumors pheochromocytomas and paragangliomas (PCC/PGL) that become malignant. Scientists reported that somatic alpha thalassemia/mental retardation syndrome X-linked (ATRX) mutations were identified in two of seven succinate dehydrogenase complex, subunit B, iron sulfur (SDHB)-associated tumors. To determine the frequency of somatic ATRX mutations in PCC/PGL, the team sequenced the ATRX coding region in a separate set of 103 tumors samples. They found that 13% of tumors had ATRX mutations. The authors concluded that although the sample set of PCC/PGL with ATRX variants is too small to identify statistically significant associations, many had clinically aggressive features, suggesting an interaction between the somatic and inherited genomes in solid cancers. The study was published on January 21, 2015, in the journal Nature Communications.

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Prosthetic Joint Infections Test Receives CE Marking he first diagnostic test that can detect in patients’ blood antibodies against several bacteria types frequently responsible for prosthetic infections has received the CE marking. This BJI InoPlex test (Diaxonit; Paris France; www.diaxonhit.com) requires 10 μL of serum taken by a simple blood draw and can be easily repeated. The test uses a combination of several recombinant protein antigens to test for antiStaphylococcus immunoglobulin G (IgG for S. aureus and S. epidermidis). The BJI InoPlex kit contains various reagents necessary to perform the test, a 96-well filter plate, and calibration CD-ROM containing specific calibration information for each batch and a user manual. The BJI InoPlex software is used to interpret the data and report a result per family of bacteria.

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Annual Review 2015 Microdiversity Predicts Outcome In Children’s Kidney Cancer prognosis for the outcome of Wilms’ tumor, the most common type of kidney cancer in children, can be determined by examining the genetic variation in a biopsy specimen as small as one millimeter in diameter. Investigators termed genetic variation in such minute samples as microvariation or microdiversity. They established the importance of this type of variation by analyzing millimeter sized specimens from 44 cases of Wilms’ tumor. All 44 patients had been treated with chemotherapy and while most recovered, a few—whose cancers demonstrated the greatest genetic variation between cells—developed metastases and died. Survival was 100% for patients lacking microdiversity. The study was published in the January 27, 2015, online edition of the journal Nature Communications.

Automated MRSA/SA Test Receives US FDA Approval

n automated real-time polymerase chain reaction (PCR) assay for the detection of methicillinresistant Staphylococcus aureus (MRSA) and

Year’s Top 100 Clinical Developments Staphylococcus aureus (SA) DNA directly from nasal swabs has been certified for diagnostic use in the United States. The [US] Food and Drug Administration (FDA) has issued 510(k) clearance, which allows marketing as a diagnostic tool, for the Roche (Basel, Switzerland; www.roche.com) cobas MRSA/SA Test for the early, simultaneous detection of MRSA and SA directly from nasal specimens. The cobas MRSA/SA assay was developed for use on the cobas 4800 system. The test joins the expanding US system menu that currently includes the cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, and the cobas EGFR Mutation Test.

Difficulties in Distinguishing Chikungunya Virus Infection From Rheumatoid Arthritis study involving travelers who contracted Chikungunya virus (CHIKV) infection in Haiti has highlighted the similarities between this viral infection and rheumatoid arthritis and emphasized the difficulty faced by diagnosticians. To this end, they analyzed blood samples from 10 individuals who be-

came infected with CHIKV, from rheumatoid arthritis (RA) patients, and healthy controls. Patients with CHIKV arthritis had detectable anti-CHIKV IgG. Among the 10 CHIKV-infected individuals, 8 developed persistent symmetric polyarthritis. Analysis revealed that RA and CHIKV-infected patients had greater percentages of activated and effector CD4+ and CD8+ T-cells than healthy controls. Investigators established an online registry at http://chikv.dom.wustl.edu to build a database for studying the virus in detail. The study was published in the January 20, 2015, online edition of the journal Arthritis and Rheumatology.

FEBRUARY MicroRNA Panel Distinguishes Between High- and Low-Risk Pancreatic Lesions panel of six microRNAs (miRNAs) has been identified that can distinguish between high-risk and low-risk pancreatic lesions that are capable of progressing to full-blown cancer of the pancreas. To aid in early detection of pancreatic cancer, investigators at the Moffitt Cancer Center (Tampa, FL, USA; www. moffitt.org) used advanced genomic tools to analyze the miRNAs associated with low-risk and high-risk Intraductal papillary mucinous neoplasms (IPMNs). They performed genome-wide miRNA expression profiling on 28 surgically-resected, pathologically-confirmed IPMNs (19 high-risk, 9 low-risk). Results revealed that six miRNAs (miR-100, miR-99b, miR-99a, miR-342-3p, miR-126, miR-130a) were downregulated in high-risk versus lowrisk IPMNs and distinguished between these groups. Low miR-99b expression was associated with main pancreatic duct involvement, and serum albumin levels were positively correlated with miR-99a and miR-100 expression.

Simple Method Monitors β-Cell Death in Type 1 Diabetes Individuals he β-cell killing that characterizes type 1 diabetes (T1D) is thought to begin years before patients present clinically with metabolic decompensation. However, this primary pathologic process of the disease had not been measured. A method was developed for assessing β-cell death in vivo by measuring the relative amount of β-cell-derived unmethylated insulin (INS) DNA in the circulation. At-risk subjects, those who progressed to T1D, had average levels of unmethylated (INS) DNA that were elevated modestly compared with those of healthy control subjects. In atrisk individuals that progressed to T1D, the observed increases in unmethylated INS DNA were associated with decreases in insulin secretion, indicating that the changes in unmethylated INS DNA are indicative of βcell killing. The study was published on February 2, 2015, in the Journal of Clinical Investigation.

Breakthrough Blood Test Developed For Bowel Cancer Diagnosis test that will pick up on antibodies in the blood, produced as the body reacts to the onset of bowel cancer has been developed. The UK NHS Bowel Screening Program rolled out to check those at high risk involves a low sensitivity Fecal Occult Blood Test (FOBt). The new test will do away with the need for FOBt and will prevent unnecessary and costly colonoscopies for people without the disease. Collaboration between the UK biotech firm Randox Laboratories Ltd. (Crumlin, UK; www.randox.com) and Biomedical Diagnostics Institute (BDI; Dublin City University, Ireland; www.bdi.ie) promises that the new test will be a significant breakthrough in the diagnosis of bowel cancer and could be available for widespread use by the end of 2016. The new test will be implemented on Randox’s proprietary Biochip Array Technology detection platform.

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Annual Review 2015

Year’s Top 100 Clinical Developments

Next Generation Miniature Spectrometer Brings Flexibility to Diagnostics and Biotechnology

Lemierre’s Syndrome Bacteria Responsible for Many Cases Of Sore Throat in the US

he Flame spectrometer from Ocean Optics (Dunedin, FA, USA; www.oceanoptics.com) delivers thermal stability and low unit-to-unit variation with flexibility and configurability. Features such as interchangeable slits, indicator LEDs, and simpler device connectors provide flexibility for a range of UV-Vis applications in medical diagnostics and other life sciences. Flame is suited to a variety of measurements including DNA, RNA, proteins, or blood oxygenation in the lab. It is configurable across the 190–1,100 nm wavelength range for use in absorbance, transmission, reflectance, irradiance, and color applications and comes preconfigured or custom-configured, with interchangeable slits that adjust resolution and throughput on demand. It has a thermal stability of 0.05 nm/°C from 200–850 nm and its small footprint (89 x 63 x 34 mm) and low weight (265 g) make the Flame compact enough for integration into handheld point-of-care devices.

study in the US found that more cases of pharyngitis among students were caused by the bacterium Fusobacterium necrophorum than by hemolytic streptococci or by Mycoplasma pneumoniae. The anaerobic bacterium was shown in European studies to account for about 10% of sore throats and was the primary cause of Lemierre’s syndrome. Study results revealed that F. necrophorum was detected in 20.5% of patients and 9.4% of asymptomatic students. Group A beta-hemolytic Streptococcus was detected in 10.3% of patients and 1.1% of asymptomatic students. Group C/G beta-hemolytic Streptococcus was detected in 9.0% of patients and 3.9% of asymptomatic students. Mycoplasma pneumoniae was detected in 1.9% of patients and in none of the asymptomatic students. The study was published in the February 17, 2015, online edition of the journal Annals of Internal Medicine.

Simple Blood Test Can Predict Dementia Risk biomarker has been identified that can predict the risk of developing dementia by way of a blood test. The apolipoprotein E (APOE) ε4 allele is a major genetic risk factor for Alzheimer disease and dementia; however, it remains unclear whether plasma levels of apoE confer additional risk. Scientists tested whether low plasma levels of apoE were associated with increased risk of future Alzheimer disease and all dementia, and whether this association was independent of ε2/ε3/ε4 APOE genotype. They concluded that low plasma levels of apoE are associated with increased risk of future Alzheimer disease and all dementia, independent of ε2/ε3/ε4 APOE genotype. This is clinically relevant, because no plasma biomarkers are currently implemented. The study was published in the February 2015 issue of the journal Annals of Neurology.

Pivotal Study Supports Modern Blood Test Over Common Skin Test For Latent Tuberculosis Screening study in China finds, by comparison with results from a highly accurate commercial interferon-gamma release assay (IGRA)-based QuantiFERON-TB Gold (QFT) test from QIAGEN N.V. (Venlo, Netherlands and Hilden, Germany; www. qiagen.com) that screening with a still commonly used tuberculin skin test (TST) for latent Mycobacterium tuberculosis (TB) infection (LTBI) clearly results in unacceptably high numbers of false positives and overestimation of infection rates. Upon screening people in rural China, results showed a far lower overall LTBI rate of 18.8% as measured by QFT compared to 28% by TST. The higher false-positive rate of TST is due to several factors, including the use of Bacille Calmette-Guérin (BCG) vaccination since the 1950s, which has had only a very limited impact on reducing TB burden. The study was published online February 10, 2015, in the journal the Lancet.

Whole Genetic Code of IVF Embryos Scanned for Mutations ethods available for preimplantation genetic diagnosis of in vitro fertilized (IVF) embryos do not detect de novo single-nucleotide and short indel mutations. Genomic scientists at Complete Genomics, Inc. (Mountain View, CA, USA; www. completegenomics.com) used a technique that allows the whole genome of IVF embryos to be scanned via the cells of 10 biopsies. Using just 10 cells to do the wholegenome sequencing means the DNA has to be amplified, which can introduce errors. Scientists working with another commercial team from Reprogenetics (Livingston, NJ, USA; www.reprogenetics.com) used the technique to remove any falsely identified genetic mutations using their “long fragment read” technology resulting in the removal of 100,000 sequencing errors, reducing the error rate approximately 100-fold over previous studies. The study was published on February 11, 2015, in the journal Genome Research.

MARCH Biomarkers Show Promise to Improve Prostate Cancer Care wo biomarkers have been discovered that may improve oncologists’ ability to predict whether prostate cancer will recur. Scientists utilized prostate tissue samples that were taken from men who underwent radical prostatectomy. The team determined the frequency of genomic mutations or amplification of two proteins the Y-box binding protein (YB-1) and the Metastasis-associated protein (MTA1). The investigators

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Year’s Top 100 Clinical Developments

found that patients with higher levels of the two proteins, YB-1 and MTA1, were much more likely to suffer prostate cancer recurrence and three times as likely to require treatment such as hormone therapy or radiation therapy. Moreover, adding YB-1 and MTA1 levels to clinical factors currently used to predict prostate cancer recurrence improved their predictive potential. The study was published on March 3, 2015, in the journal Oncotarget.

includes device management, operator management, quality control, compliance reporting, competency management, inventory management, remote monitoring, and mobile access. Ecosystem takes the core needs of a POC program into consideration with a focus on helping POC coordinators improve control, effectiveness, and transparency. It manages secure access to POC devices, oversees QC, and identifies and resolves issues.

New Integrated Systems Solution Increases Point-of-Care Testing Workload

Effectiveness of POC Diagnostics For Schistosomiasis Reviewed

hallenges faced by clinical laboratory point-ofcare (POC) coordinators can be more efficiently tackled with an innovative approach developed as a new component of an informatics solution for managing in vitro diagnostics (IVD) analyzers and operators. Siemens Healthcare Diagnostics (Erlangen, Germany; www.healthcare.siemens.com) offers its new Ecosystem solution, an integrated component of its RAPIDComm Data Management System, an informatics solution that centrally manages Siemens IVD analyzers and operators. Ecosystem, which encompasses eight core components,

review suggests that current point-of-care (POC) tests are less reliable than conventional microscopy. Studies compared POC tests to microscopy as reference standard: for Schistosoma haematobium—microscopy of urine prepared by filtration, centrifugation, or sedimentation; for S. mansoni—microscopy of stool by Kato-Katz thick smear. Among the urine reagent strip (URStrip) tests for urinary schistosomiasis, those for detecting blood were more accurate than those for detecting protein or white cells. Sensitivity and specificity estimates: for blood 75% and 87%; for protein 61% and 82%; for white cells 58% and 61%, re-

spectively. For urinary schistosomiasis, circulating antigen (CA) test performance was worse (39% sensitivity, 78% specificity) than URStrips for blood. For intestinal schistosomiasis, CA test detected many infections identified by microscopy but wrongly labeled many uninfected people. The review was published online March 11, 2015, in Cochrane Database of Systematic Reviews.

Chinese Bird Flu Strains Retain Specificity for Avian Receptors olecular virologists found no indication of a looming “bird flu” pandemic when they determined that two strains of bird flu that had sickened and killed several individuals in China were better adapted to bird cell receptors and only bound weakly to the human analogs. Investigators examined the two influenza subtypes H10N8 and H6N1. Results of binding assays, sialoside glycan microarray analysis, and X-ray crystallography studies revealed that both strains preferentially interacted with avian receptor analogs rather than human ones. Furthermore, introduction of mutations into the receptor-binding site known to convert other viral hemagglutinin subtypes from avian to human receptor specificity failed to switch preference to human receptors. Results of studies on the bird flu subtypes were published in two papers in the March 11, 2015, issue of the journal Cell Host & Microbe.

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Tests for Cervical and Other Genital HPV Cancers Introduced molecular laboratory service now offers human papillomavirus (HPV) testing of low- and highrisk genotypes using cutting-edge technology, including next-generation DNA sequencing platforms. Medical Diagnostic Laboratories, LLC (MDL; Hamilton, NJ, USA; www.mdlab.com) and its division, the Institute for Biomarker Research, have announced offering of a diverse panel for high-accuracy genetic HPV testing. The MDL HPV Type-Detect 3.0 tests identify the presence of DNA from 5 low-risk HPV genotypes: HPV 6, 11, 42, 43, 44; and 14 high-risk genotypes: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. MDL’s HPV reflex testing includes HPV 16 and HPV 18 RNA expression, HPV 16 viral load, HPV 16 integration status and E6 variants. Minimally-invasive, simple specimen collection methods are provided.

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Biomarkers Differentiate Mild Brain Trauma from Other Types of Injury panel of protein biomarkers has been established that can identify patients with mild traumatic brain injury (mTBI) and differentiate those patients from healthy individuals and from patients with other injuries including broken bones. Investigators sought to identify proteins whose synthesis was altered after mTBI and whose blood levels could be measured using standard immunoassays. They measured 18 different proinflammatory proteins and four candidate biomarkers were identified: copeptin, galectin 3 (LGALS3), matrix metalloproteinase 9 (MMP9), and occludin (OCLN). The plasma concentration of copeptin was found to be lowered by 3.4-fold in mTBI patients within eight hours after accident as compared to uninjured controls. Plasma levels of GALS3, MMP9, and OCLN increased 3.6–4.5-fold within the same time frame post-injury. The study was published in the March 20, 2015, online edition of the Journal of Neurotrauma.

Screening Strategy Reduces Incidence of Immigration-Related Tuberculosis mplementation of the culture-based algorithm may have substantially reduced the incidence of tuberculosis (TB) among newly arrived, foreignborn persons in the US. CDC scientists revised the screen-

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Year’s Top 100 Clinical Developments ing strategy to use a more inclusive culture-based algorithm. They reviewed the increase of smear-negative/culture-positive Mycobacterium tuberculosis cases diagnosed overseas between 2007 and 2012 and compared that figure with the decline of reported TB cases among foreign-born persons within one year after arrival in the US. Among the TB cases diagnosed by the culture-based algorithm 54.4% were smear-negative/culture-positive. The authors concluded that the increased annual number of TB cases detected in immigrants closely matched in magnitude a decrease in the number reported TB cases, suggesting that the culture-based algorithm effectively reduced TB incidence. The study was published on March 17, 2015, in the journal Annals of Internal Medicine.

Monitoring Calcitriol May Help Prevent Chronic Heart Failure Death n patients with chronic heart failure, the vitamin D metabolite 1,25-dihydroxyvitamin D (1,25(OH)2D), also called calcitriol, and its ratio to parathyroid hormone (PTH 1-84) may help predict cardiovascular death. Scientists examined the ability of calcitriol and its ratio with PTH(1-84) to predict cardiovascular death in chronic heart failure, and determined the patients’ calcitriol and PTH(1-84) levels at baseline. The investigators found that serum calcitriol levels decreased markedly according to heart failure severity, and that decreased ratios of calcitriol to PTH(1-84) were significantly related to heart failure severity. In patients with heart failure, vitamin D deficiency and hyperparathyroidism are common, and evidence is growing for the role of vitamin D and PTH in worsening heart failure. The study was presented at the annual meeting of the Endocrine Society, ENDO 2015 held March 5–8, 2015, in San Diego (CA, USA; www.endocrine.org).

(mHTT) immunoassay. They found that mHTT was present in the cerebrospinal fluid (CSF) of almost all HTT mutation carriers, but not in that of control volunteers. In one cohort, they were able to detect 182.5 ± 106.3 femtomolar (fM) mHTT in the CSF of all nine mutation carriers, but not in the CSF of any of the three controls. In a more diverse cohort, they detected 289.1 ± 194.6 fM mHTT in the CSFs of 26 of 28 HTT mutation carriers, but not in any of the 10 controls. The study was published on April 6, 2015, in the Journal of Clinical Investigation.

Buccal Swabs Replace Phlebotomy for Postnatal and Pediatric DNA Collection

CombiMatrix Corporation (Irvine, CA, USA; www. combimatrix.com) a molecular diagnostics company specializing in DNA-based diagnostic services for prenatal, postnatal, and pre-implantation genetic testing has introduced its new Buccal Swab DNA Collection system for the collection of samples to be analyzed with its CombiSNP Array for Pediatric Analysis microarray test. When using the Buccal Swab system, the patients swabs both cheeks, caps the tube, and then inverts it to mix the DNA with the special preservative solution. Samples are then sent to the CombiMatrix testing laboratory in Irvine (CA, USA), where the DNA is extracted and analyzed on the same test platform as used for blood samples.

Device Leads to Pain-Free Blood Tests

ollection of samples for prenatal and pediatric DNA sequencing procedures is now available via buccal swabs rather than by phlebotomy.

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APRIL Ready-to-Use Control Determines Linearity for Special Diabetes Tests clinical lab quality control product simulates human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range for special diabetes tests. The Linearity LQ Special Diabetes from AUDIT MicroControls, Inc. (Eatonton, GA, USA; www. auditmicro.com) is an assayed quality-control material consisting of 5 distinct levels that demonstrate a linear relationship to each other when assayed for C-peptide, fructosamine, and insulin. It is a ready-to-use liquid product with open vial stability of 7 days when stored at 2–8 °C. AUDIT MicroControls provides “Auditor QC,” a free on-line, real-time data reduction program that offers Levey-Jennings charts and peer group analysis for daily quality control product users, as well as linearity graphs and peer group analysis.

Huntington’s Disease Protein Quantified in Cerebrospinal Fluid n immunoassay for the first time measured the build-up of a harmful mutant protein in the nervous system of patients during the progression of Huntington’s disease. Scientists developed an ultrasensitive single-molecule counting mutant huntingtin protein

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device the size of a Ping-Pong ball can extract a small blood sample while held against the skin for two minutes which may make blood sam-

Annual Review 2015 pling less painful and more convenient. Scientists at the University of Wisconsin-Madison (WI, USA; www. wisc.edu) developed the device that can the device can extract about 0.15 mL of blood , which is enough to test cholesterol levels, infection biomarkers, cancer cells and blood glucose. A slight vacuum in the device enables a small sample of blood to flow into an attached sample tube and users report that the process is almost entirely painless. The device is being perfected by Tasso Inc. (Madison, WI, USA; www.tassoinc.com). The company has applied for a patent on channels that create capillary action to move blood toward the sample tube.

Diagnostics of Fixed Soil-Transmitted Helminth Infection Assessed ato-Katz is a widely used method for the diagnosis of soil-transmitted helminth infection, but fecal samples cannot be preserved. Scientists enrolled children and their stool samples were subjected on the day of collection to a single Kato-Katz thick smear and Mini-FLOTAC examination. The study was carried out in late 2013 on Pemba Island (Tanzania). The authors conclude that for a qualitative diagnosis of soiltransmitted helminth infection, stool samples can be fixed in 5% formalin for at least 30 days. However, for an accurate quantitative diagnosis of hookworm, they suggest a limit of 15 days of preservation. Their results have direct implication for integrating soil-transmitted helminthiasis into transmission assessment surveys for lymphatic filariasis. The study was published on April 7, 2015, in the journal Public Library of Science Neglected Tropical Diseases.

Multiplex Nucleic Acid Suspension Bead Array Detects Filoviruses ultiplex suspension bead array systems that allow fast and reliable detection of reverse transcriptase polymerase chain reaction (RTPCR) amplified filovirus genomes and enabled subtyping of Ebolavirus (EV) species and Marburgvirus (MV) strains has been described. Scientists set up a multiplex suspension bead array system, by designing two different RT-PCRs that could amplify all known EV and MV species, respectively, based on whole-

Yearâ&#x20AC;&#x2122;s Top 100 Clinical Developments genome sequences of Filoviruses, including Reston ebolavirus, and Bundibugyo ebolavirus. The EV system can distinguish between three EV species and the MV system can distinguish between four MV strains. The multiplex suspension bead array system developed can easily be adapted to emerging new strains by including additional beads. The study was published in the April 2015 issue of the Journal of Clinical Microbiology.

thousands of genes simultaneously. They reported detecting an APOBEC mutational signature in 3.8% of cases. APOBEC, also known as apolipoprotein B mRNA-editing enzyme, encodes a member of the AID/APOBEC family of polynucleotide (deoxy) cytidine deaminases, which convert cytidine to uridine. Patients with a genetic signature that included the APOBEC mutation had an increased mutational load and a poor prognosis for recovery.

Next-Generation Hemoglobin Analyzer Ensures Bidirectional Data Management Future Proofing

MAY

point-of-care (POC) diagnostics analyzer delivers quantitative laboratory-accurate hemoglobin and hematocrit results in one simple test and uniquely enables upgrade with data management functionality as required, giving broad flexibility over future connectivity options via its bidirectional interface. The new portable Hemo Control from EKF Diagnostics (Cardiff, UK; www.ekfdiagnostics.com) provides accuracy and reliability of results (imprecision of <2%) from 25 seconds for blood banks, hospitals, and clinics. It can easily communicate with in-house systems: using the new LIS2-A2 communication standard, this bidirectional interface allows the analyzer to connect directly to third party software and enable simple integration with LIS (Laboratory Information System) middleware. The cost-effective basic device stores up to 4,000 patient results and offers enhanced on-board Data Management (DM) functions following upgrade.

Gene Mapping Reveals Mutation in Myeloma Patients Linked to High Risk of Treatment Failure ene mapping of patients suffering from myeloma has enabled the identification of a genetic signature linked to the likelihood of the disease becoming more genetically complex and more likely to evolve into treatment-resistant forms. Investigators at the Institute of Cancer Research (London, United Kingdom; www.icr.ac.uk) sequenced presenting cases of myeloma enrolled in the UK Myeloma XI study using whole exome sequencing, which determines the DNA sequence of the protein-coding exon regions of tens of

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Rapid Sepsis Assay Available for Clinical Chemistry Analyzers test kit for rapid detection of sepsis through quantitative measurement of procalcitonin is available for use on almost any liquid-based chemistry analyzer. Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, which is involved with calcium homeostasis. The global diagnostics company EKF Diagnostics (Cardiff, UK; www.ekfdiagnostics.com) has introduced the Procalcitonin (PCT) LiquiColor Assay produced by its subsidiary Stanbio Chemistry (Boerne, TX, USA; www.stanbio.com) for rapid detection of sepsis. The LiquiColor assay employs latex enhanced immunoturbidimetric methodology to determine quantitatively the level of PCT in serum samples and in EDTA, lithium, or heparin plasma samples. The test requires just 20 microliters of sample and can be run on almost any liquid-based chemistry analyzer with open-channel capability. Results are available within 10 minutes.

Gene Mutation Test Diagnoses Myeloid Neoplasms range of gene mutations are associated with myeloid neoplasms. Next-generation sequencing technologies can simultaneously test for mutations in multiple genes associated with myeloid neoplasms to diagnose, sub-classify, monitor, and predict the course of disease. LeukoVantage (Quest Diagnostics; Madison, NJ, USA; www.questdiagnostics.com) is a laboratory developed test that uses next-generation sequencing, polymerase chain reaction, and other techniques to interrogate DNA from leukocytes in blood or bone marrow specimens for the presence of mutations

Annual Review 2015

Year’s Top 100 Clinical Developments in 30 genes most frequently associated with myeloid neoplasms. For myelodysplastic syndrome, LeukoVantage may detect certain molecular markers to help identify early stages of the disease, complementing conventional diagnostic techniques. For myeloproliferative neoplasms, LeukoVantage may identify molecular markers that can aid the selection of certain targeted therapies, such as Janus kinase 2 (JAK2) inhibitors, and establishing a prognosis.

on optical polarimetry that is different from previous polarimetric systems which rely on free-space components. The study, by Harrison MC and Armani AM, was published online May 14, 2015, in the journal Applied Physics Letters.

Panel of Bloodstream MicroRNAs Predicts Damage From Radiation Exposure

method that combines phase contrast microscopy with holography enables prediction of the likelihood of prostate cancer recurrence prior to biopsy or surgery. Spatial light interference microscopy (SLIM), uses a commercial phase contrast microscope and white light illumination, resulting in nanometer scale sensitivity to optical path-length shifts. In essence, SLIM combines phase contrast microscopy

Spatial Light Interference Microscopy Predicts Risk of Prostate Cancer Recurrence Prior to Biopsy or Surgery

panel of microRNAs (miRNAs) that can be measured in blood samples is able to predict the extent of long-term radiation injury and likelihood of survival following exposure to high doses of radiation. Investigators identified serum miRNA signatures that indicate long-term impact of total body irradiation (TBI) in mice when measVisit us at ured within 24 hours of exposure. The investigators systematically assessed the impact of TBI on the bone marrow’s blood-cell production system to determine a correlation of residual MEDLAB hematopoietic stem cells (HSCs) with increasStand Z5A10 ing doses of radiation. In addition, they found that 68 of 170 miRNAs detected in blood serum changed with radiation exposure. This number was reduced to a panel that acted as a “signature” of radiation dose. The paper was published in the May 13, 2015, online edition of the journal Science Translational Medicine.

with holography. Investigators used the SLIM technique to examine tissue samples obtained from individuals who had a prostatectomy, approximately half who had no recurrence and half who did. The resulting SLIM image contained rich information about tissue morphology, with the glandular epithelium and stroma structures clearly resolved. This allowed the investigators to interrogate scattering changes specific to prostate stroma. The study was published in the May 15, 2015, online edition of the journal Scientific Reports.

New Method for Genome Analysis of Drug Resistant Tuberculosis Bacteria Directly from Patient Samples

Small Molecule Detects Alzheimer’s at Early Stages high level of a molecule called D-serine have been identified as associated with cognitive decline in Alzheimer’s disease (AD) and holds the potential to represent a novel and effective biomarker for AD. By looking at postmortem tissue from AD patients, the team found that D-serine is abnormally high in the hippocampus and cortex, regions severely affected by AD. They further found that increases in D-serine could be caused by the accumulation of amyloid-beta oligomers, toxins known to play a central role in AD. Their main discovery, however, was that D-serine levels were elevated in the cerebral spinal fluid of probable AD patients who already display early clinical symptoms. The authors concluded that including D-serine measurements into an amyloid-tau score (IATI) assists in AD diagnosis. The study was published on May 5, 2015, in the journal Translational Psychiatry.

Portable Device Could Test For Physical Property of Tumor Aggressiveness polarimetric fiber stress sensor device has been developed for viscoelastic and biomimetic material analysis, and, as part of the emerging field of physical oncology, is being tested for measuring a tumor’s Young’s modulus – an elasticity-related measure recently linked to cancerous tumor aggressiveness. Engineers developed the device and in preliminary testing found that more aggressive tumors are generally stiffer, a complex relationship that requires further study. The device itself is an important step in the challenge of developing nondestructive methods to characterize physical properties of biological materials, and will be suitable for a wide variety of applications. It is an all-fiber-based material analysis device based

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European research consortium has developed a test for the detection of drug resistant strains of the tuberculosis (TB) bacterium Mycobacteri-

Annual Review 2015 um tuberculosis, which yields results within a few days rather than the period of weeks that is required by current methods. The new procedure allows whole gene sequencing of M. tuberculosis in samples of patients’ sputum. The technique utilizes biotinylated RNA baits, designed specifically for M. tuberculosis DNA, to capture full M. tuberculosis genomes directly from infected sputum samples, allowing whole genome sequencing without the requirement of culture. Details of the new method were published in the May 13, 2015, online edition of the Journal of Clinical Microbiology.

Microfluid Chip Traps Migrating Tumor Cell Clusters microfluidic chip has been developed that can capture rare clusters of circulating tumor cells. Scientists used the new chip to capture and analyze circulating tumor cell (CTC) clusters from patients with metastatic breast, prostate and melanoma cancers. The chip was designed to slowly push blood through many rows of microscopic triangle-shaped posts. To determine the efficiency of the device called Cluster-Chip, the team introduced fluorescently tagged cell clusters, ranging from 2 to 30 cells, into the chip and counted the number of clusters that were captured and the number that flowed through undetected. At a blood flow rate of 2.5 mL/hour, the chip captured 99% of clusters containing four or more cells, 70% of three-cell clusters, and 41% of two-cell clusters. The study was published on May 18, 2015, in the journal Nature Methods.

JUNE Capillary Zone Electrophoresis Developed for Rapid Determination of Thalassemia capillary zone electrophoresis (CZE) method has been developed for human globin determination in the diagnosis of thalassemia and hemoglobin variants. Scientists at the Southern Medical University (Guangzhou, China; www.fimmu.com) evaluated an assay on blood samples obtained from anticoagulated whole blood from a total of clinical samples consisting of normal, α-thalassemia silent/trait, 42 βthalassemia carriers, and 63 β-thalassemia major and βthalassemia intermedia (β -TM/TI), and others with various hemoglobinopathies. The authors concluded that they had successfully developed a rapid, high-resolution CZE method for the separation of globin chains using highly acidic buffer and uncoated capillaries. Using this method, α-, β- and γ-chains, and αWS and αG Honolulu chains were separated within 17 minutes, indicating suitability for routine clinical applications. The study was published in the June 2015 issue of the journal Blood Cells Molecules and Diseases.

Automated HSV1 and 2 Test Receives Approval n automated real-time polymerase chain reaction (PCR) assay for the direct detection and differentiation of HSV1 (herpes simplex virus 1) and HSV2 (herpes simplex virus 2) DNA in anogenital specimens from symptomatic patients has been certified for diagnostic use in the United States. The [US] Food and Drug Administration (FDA) has issued 510(k) clearance, which allows marketing as a diagnostic tool, for the Roche (Basel, Switzerland; www.roche.com) cobas HSV1 and 2 Test for the early, simultaneous detection of HSV1 and HSV2. The Roche HSV assay was developed for use on the cobas 4800 system, which was designed to automatically perform real-time PCR for medium- to high-throughput laboratories. It incorporates fully automated sample preparation from primary vials with ready-to-use, load-and-go reagents.

Year’s Top 100 Clinical Developments New Assay Defines Total Virus Burden n advanced bacteriophage-based microarray assay allows the simultaneous identification of all the viruses comprising an individual’s virome from a sample of less than one microliter of blood. The new assay method, VirScan, is a high-throughput technique that allows comprehensive analysis of antiviral antibodies in human sera. The technique is based on a library of bacteriophages that carry DNA fragments specific for more than 93,000 different segments of viral proteins. The bacteriophages produce distinct surface peptides that bind to anti-viral antibodies in the patient’s blood. Immunoprecipitation and high-throughput DNA sequencing reveal the peptides recognized by antibodies in the sample. The study was published in the June 5, 2015, issue of the journal Science.

CE-IVD Mark for Simultaneous Helicobacter Pylori and Antibiotic Resistance Test unique test is a first-available, noninvasive molecular assay for stool sample detection of the gastric pathogen Helicobacter pylori as well as of clarithromycin resistance, one of H. pylori’s key resistances. The test “Amplidiag H. pylori+ClariR” from Mobidiag Ltd. (Espoo, Finland; http://mobidiag.com) is immediately available throughout Europe, expands the gastrointestinal Amplidiag menu, and contributes to the global fight against gastric cancers. The test is a rapid, qualitative qPCR-based assay performed directly from stool DNA extract, and aims at primary testing in cases where H. pylori infection is suspected. It is cost-effective especially for high-volume screening in mid-sized to large laboratory settings. Through its unique ability to detect a key antibiotic resistance in conjunction with the pathogen, the test enables targeting of primary eradication therapy without invasive procedures and additional waiting.

Endoscopic Samples Show Precancerous Genomic Changes In Barrett’s Esophagus ext-generation sequencing (NGS) has been used to detect genomic mutations in precancerous esophageal tissue, which may improve cancer surveillance and early detection in patients with Barrett’s esophagus (BE). Scientists selected two groups of patients: 13 “non-progressors” with BE who never manifested dysplasia or esophageal adenocarcinoma (EAC) and 15 “progressors” who developed high-grade dysplasia (HGD) or EAC. They found progressors had mutations in 75% (6/8) of cases compared to 0% in non-progressors. Mutations were also found in the adenomatous polyposis coli (APC) and cyclin-dependent kinase inhibitor 2A (CDKN2A) tumor suppressor genes. The authors concluded that DNA from routine endoscopic FFPE samples of non-dysplastic Barrett’s intestinal metaplasia can be efficiently used to simultaneously detect multiple mutations by NGS with high analytical sensitivity. The study was published in the July 2015 issue of the Journal of Molecular Diagnostics.

Rare Hereditary Autoimmune Disease Found to Have More Common Form esearchers have discovered that single-allele mutations in the gene that causes recessive autoimmune polyendocrine syndrome type-1 (APS-1) can cause a less severe but more common condition. APS-1, caused by recessive mutation in the AIRE (AutoImmune REgulator) gene, is a constellation of medical problems ranging from attack on and destruc-

tion of multiple tissues and organs, to chronic infections. Scientists challenged this widely accepted notion that clinical symptoms will arise only if both AIRE alleles are dysfunctional and found that even a single-allele mutation may disrupt function and cause devastating autoimmunity. AIRE proteins bind one another, forming an active complex. A specific mutation in one copy is enough to disrupt function of the entire complex in a dominantlike manner. The study, by Oftedal BE et al., was published June 16, 2015, in the journal Immunity.

Overexpression of X Chromosome Genes Is Biomarker for Female Mental Disorders levated expression of the genes XIST (X-inactive specific transcript) and KDM5C (lysine-specific demethylase 5C) could be used as a biological marker for diagnosis of major affective disorders in a significantly large subset of female patients from the general population. Investigators studied expression of XIST and several X-linked genes in 36 lymphoblastoid cell lines from healthy females and 60 lymphoblastoid cell lines from female patients with either bipolar disorder or recurrent major depression. Results revealed that the XIST gene was significantly over expressed in the lymphoblastoid cells of female patients with either bipolar disorder or major depression. The X-linked escapee gene KDM5C also displayed significant up-regulation in the patients’ cells. Expression of XIST and KDM5C was highly correlated. The paper was published in the June 16, 2015, online edition of the journal EBioMedicine.

New Assay Rapidly Detects Toxigenic C. Difficile n assay is available for simple, rapid detection of pathogenic Clostridium difficile in fecal samples using the CE-marked GenRead molecular diagnostics system. Orion Diagnostica Oy (Espoo, Finland; www.oriondiagnostica.com) has launched Orion GenRead C. difficile kit, enabling fast and accurate detection directly from fecal samples. The test supports earlier treatment decisions by detecting strong positive samples in 15 minutes. Orion GenRead tests are used on the GenRead instrument and are based on SIBA, Orion Diagnostica’s proprietary isothermal nucleic acid amplification technology. SIBA is a robust and highly specific technology that allows fast, continuous amplification of nucleic acids. The use of SIBA in assays combined with the Orion GenRead instrument and its intuitive user interface enables C. difficile testing outside of traditional PCR laboratories.

JULY Recent Mutations Responsible For Plague Bacteria’s Virulence team of molecular microbiologists has found that acquisition of single protein early in its existence enabled the plague bacterium Yersinia pestis to invade lung tissue, but that it required later mutations of this gene to enable the organism to rapidly spread to the lymph nodes and cause the bubonic form of the disease. Investigators worked with ancestral strains of Y. pestis in mouse models and found that the acquisition of a single gene encoding the protease Pla was sufficient for the most ancestral, deeply rooted strains of Y. pestis to cause pneumonic plague. It became apparent that as Y. pestis further evolved, modern strains acquired a single amino-acid modification within Pla that optimized protease activity. While this modification was unnecessary to cause pneumonic plague, the substitution was instead needed to efficiently induce the invasive infection associated with bubonic plague. The study was published in the June 30, 2015, online edition of the journal Nature Communications.

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Annual Review 2015 Biosensor-Based Rapid Urine Test Detects Urogenital Schistosomiasis n infrastructure-limited regions, point-of-care molecular diagnostics hold the potential to transform the management of infectious diseases. Scientists at Stanford University School of Medicine (CA, USA; www.stanford.edu) developed a strategy for a rapid one-hour molecular diagnosis of bacterial urinary tract infections using electrochemical biosensors. Urinary cells are lysed and directly applied to an array of sensors functionalized with oligonucleotide probes targeting the 16S ribosomal ribonucleic acid (rRNA) of common uropathogens. Formation of the sequence-specific hybridization complex between the pathogen rRNA and the labeled capture and detector probe pairs is detected by an enzyme tag that mediates an amperometric signal output. The investigators concluded that they have made an important step toward development of a POC device for rapid detection of Schistosoma haematobium eggs in urine.

Panel Improves Diagnosis of Candida in Pediatric Patients n an investigational study of pediatric patients, a Candida test panel provided accurate, fast diagnosis with only 2 mL of blood. T2 Biosystems, Inc. (Lexington, MA, USA; www. t2biosystems.com) presented results from an investigational study evaluating its T2Candida Panel in pediatric patients at the 2015 American Society for Microbiology (ASM) general meeting in New Orleans (LA, USA). The study included 15 confirmed candidemia patients 5–12 years of age. The data presented showed that in each of the 15 patient samples, T2Candida was able to accurately identify the species in 3–5 hours, compared to 2–6 days for blood culture. For this study a manual pipetting protocol was adapted to enable detection from just 2 mL of blood compared to the 3 mL currently required for the standard loading procedure.

Longitudinal Cerebrospinal Fluid Biomarker Changes Predict Dementia hanges in key biomarkers of Alzheimer’s disease (AD) during midlife as seen in brain scans and cerebrospinal fluid (CSF) of healthy adults may help identify those who will develop dementia years later. The three CSF biomarker analytes that reflect and demonstrate diagnostic and prognostic utility of the core neuropathologies in AD, are β-amyloid 42 (Aβ42), total tau, and hyperphosphorylated tau (P-tau). Other recently identified biomarkers, include visinin-like protein 1 (VILIP-1) and chitinase-3-like protein 1 (YKL-40). The scientists found that drops in amyloid beta 42 levels in the cerebrospinal fluid among cognitively normal participants ages 45 to 54 are linked to the appearance of plaques in brain scans years later. The study was published on July 6, 2015, in the journal JAMA Neurology.

Automated Test for Galectin-3 Cleared for Chronic Heart Failure Prognosis igher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. An automated blood test was officially cleared by the US FDA for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The test is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform. The ARCHITECT Galectin-3 assay (Abbott Diagnostics; Abbot Park, IL,

Year’s Top 100 Clinical Developments USA; www.abbottdiagnostics.com ) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and ethylenediaminetetraacetic acid (EDTA) plasma. The ARCHITECT Galectin-3 assay is performed using the Abbott ARCHITECT automated immunoassay analyzer.

Blood Test Could Identify Diabetes Decades Before It Develops small molecule circulates in the blood of people who are in the early stages of type 1 diabetes and a simple blood test could detect this biological marker years before symptoms develop. Scientists reported that miR-375 is released by the very cells in the pancreas that produce insulin. These cells normally contain lots of miR-375, which helps to control cell growth. They concluded that their findings are supported by higher miR-375 levels in the circulation of T1D subjects but not mature onset diabetes of the young andT2D patients. Together, their data support an essential role for miR-375 in the maintenance of β-cell mass and provide in vivo evidence for release of miRNAs from pancreatic β-cells. The study was published on May 28, 2015, in the Journal of Molecular Medicine.

Unique Streptococcus Strain Now Dominates Infection Landscape in the UK icrobiologists have identified the mutations that were responsible for the increase in virulence of a Group A Streptococcus (GAS) variant. Investigators analyzed changes in the genome of GAS genotype emm89. Results of revealed that although standard variable typing regions remained unchanged, this unique subtype had undergone six distinct regions of homologous recombination across the genome compared to the rest of the sequenced emm89 population. Two of these regions affected known virulence factors, the hyaluronic acid capsule, and the toxins NADase and streptolysin O. Loss of the hyaluronic acid capsule was a particularly surprising finding, as it had been believed by microbiologists that the capsule was essential for GAS bacteria to cause invasive disease. The work was published in the July 14, 2015, online edition of the journal mBio.

Prenatal Testing May Also Detect Some Maternal Cancers study showed that prenatal genetic test results, such as revealed by noninvasive prenatal testing (NIPT) for fetal chromosome abnormalities, may also detect underlying conditions in the mother, including cancer. Scientists reported results of their genome-wide analysis performed on available DNA sequencing data for a case series of women with abnormal NIPT results. Analysis showed discordance with the fetal karyotype: while their fetuses had normal chromosomes, retrospective genomic analysis showed that the abnormal results were due to a variety of undiagnosed cancers in the mothers. NIPT is a recent clinical advance that provides pregnant women with information about possible chromosomal abnormalities, such as Down syndrome, in their fetuses. The study, by Bianchi DW, et al., was published July 14, 2015, in the Journal of the American Medical Association (JAMA).

AUGUST Genomic Assays Identify Chikungunya Virus in Blood Donors he risk for transfusion-transmitted infection (TTI) of Chikungunya virus (CHIKV) is currently unclear, but several factors raise concern about possible TTI with this virus, including a 10% to

25% asymptomatic infection rate and high viremic titers in asymptomatic persons. Scientists developed a prototype CHIKV transcription-mediated amplification (TMA) assay to screen blood donors. They concluded that new genomic-based technologies have utility for outbreak investigation, blood borne pathogen screening, and disease surveillance. The availability of a high-throughput TMA assay will facilitate screening for CHIKV and more precisely establish the risk of transfusion-associated transmission. Panviral microarrays are useful for broad surveillance of blood borne pathogens yet rigorous individual probe validation across multiple targets is needed because of potential cross-hybridization artifacts. The study was published in the August 2015 issue of the journal Emerging Infectious Diseases.

Approved Diagnostic Test Differentiates Between HIV Infection Types n FDA-approved diagnostic assay differentiates between Human immunodeficiency virus 1 (HIV-1) antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. The BioPlex 2200 HIV Ag-Ab assay (Bio-Rad Laboratories, Inc., Hercules, CA, USA; www.bio-rad.com) is to aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute HIV-1 infection. It may be used in adults, children two years of age and older, as well as in pregnant women. The assay may also be used to screen organ donors for HIV-1/2 when the blood specimen is collected while the donor’s heart is still beating. However, the assay is not approved for use in screening blood or plasma donors, except in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.

Finnish Gastric Cancer Biomarker Tests to Be Used in Large Chinese Screening Study panel of tests produced by a Finnish biomedical company that assess gastric cancer risk will be used in a large screening study of asymptomatic persons in China. The Biohit Oyj (Helsinki, Finland; www.biohithealthcare.com) GastroPanel is a set of four ELISA kits that diagnose Helicobacter pylori infection and atrophic gastritis by determining levels of the biomarkers pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17), and H. pylori antibodies. The tests are noninvasive and performed upon small blood samples. The gastric cancer risk screening study was organized by the China Health Promotion Foundation, a public organization managed by the Chinese Ministry of Health. Testing of approximately 500,000 40–80-year-old asymptomatic persons with GastroPanel assays will be conducted at fifty to one hundred primary healthcare centers across China.

Robust Biomarker Panel Diagnoses Pancreatic Cancer in Urine oninvasive biomarkers for early detection of pancreatic ductal adenocarcinoma (PDAC) are currently not available, but a set of urinary proteins have been identified that are able to distinguish patients with early-stage PDAC from healthy individuals. Scientists analyzed urine samples from patients with pancreatic cancer, alongside samples from patients with chronic pancreatitis and from healthy individuals. Of the 1,500 proteins identified 3 – Lymphatic Vessel Endothelial Hyaluronic Acid Receptor 1 (LYVE1), Regenerating Islet-Derived 1 Alpha (REG1A) and Trefoil Factor 1 (TFF1) – were found at significantly higher levels in the urine samples of patients with pancreatic cancer, compared with the samples from healthy individuals. Patients with chronic pancreatitis, however, had much lower levels of all three proteins in their urine than pa-

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tients with pancreatic cancer. The study was published on August 1, 2015, in the journal Clinical Cancer Research.

Padlock Probe Assay Rapidly Detects Cardiac Disease Gene Mutations

Microfluidic Device Rapidly Detects Urinary Tract Infections

next generation sequencing assay for detecting cardiac disease gene mutations improves on accuracy, flexibility, turnaround time, and cost. By using double-stranded DNA probes (complementary long “padlock” probes or cLPPs), investigators reduced the scale of analysis needed to diagnose hereditary cardiovascular abnormalities. The cLPP-based method analyzes only the 88 genes known to carry heart defect mutations, costs about USD 100 per patient, and returns results within three days. The investigators reported in the August 11, 2015, online edition of the journal Circulation Research that they had used cLPPs to capture and amplify the entire coding region and flanking intronic and regulatory sequences of 88 genes and 40 microRNAs (miRNA) associated with inherited cardiac abnormalities, congenital heart disease (CHD), and cardiac development. The assay correctly detected germline variants in 24 individuals and revealed several polymorphic regions in miR-499.

polymeric centrifugal microfluidic platform has been developed for the rapid and sensitive identification of bacteria directly from urine, thus eliminating time-consuming cultivation steps. Scientists created a Lab-on-a-Disc platform that combines microfluidics and Raman microscopy, a modern optical detection method. The platform utilizes the rotationally induced centrifugal field to efficiently capture bacteria directly from suspension within a glass-polymer hybrid chip. Once trapped in an array of small V-shaped structures, the bacteria are readily available for spectroscopic characterization. Investigators confirmed that they were able to identify Escherichia coli and Enterococcus faecalis within 70 minutes, directly from patients’ urine samples. The study was published on August 11, 2015, in the journal Biomicrofluidics.

Cancer Diagnostics Lab Offers Two Week Turnaround Time n advanced cancer molecular testing laboratory can provide complete information on some 562 cancer-related genes with a turn-around time of less than two weeks. Ashion Analytics (Phoenix, AZ, USA; www.ashionanalytics.com) a [US] Food and Drug Administration CLIA (Clinical Laboratory Improvement Amendments) certified and CAP (College of American Pathologists)-accredited molecular cancer testing laboratory is now offering its Genomic Enabled Medicine (GEM) Cancer Panel to assist doctors in treating cancer patients. The 562 gene panel includes coding regions for 540 genes, and non-coding regions for an additional 22 genes that are known to be structurally rearranged or altered in cancer. Additional regions for the identification of specific structural variants are also included. Samples are tested utilizing the targeted enrichment method followed by sequencing on an Illumina, Inc. (San Diego, CA, USA; www.illumina.com) HiSeq 2500 analytical instrument.

Mutated Group B Streptococcus Causes Neonatal Sepsis treptococcus agalactiae or group B streptococcus (GBS) is a commensal of the human gut and genitourinary tract, and a leading cause of neonatal infections. Microbiologists performed wholegenome comparison of 47 GBS samples from 19 mother-child pairs, uncovered 21 single nucleotide polymorphisms and 7 insertions/deletions. Within the detected SNPs, 16 appear to have been fixed in the sampled population, whereas 5 mutations were found to be polymorphic. In the infant strains, 14 mutations were detected, including 2 independently fixed variants affecting the response regulator CovR locus, known to encode a major regulatory system of virulence. The scientists found that in 5 out of the 19 sampled newborns, mutations with a potential role in promoting virulence had occurred in GBS. The study was published on August 17, 2015, in the Journal of Bacteriology.

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SEPTEMBER ELISA Detects Measles-Specific IgG In Dried Blood Spots novel technique for measuring measles-specific immunoglobulin G (IgG) in capillary dried blood spots (DBS) using a commercial enzyme-linked immunosorbent assay (ELISA) has been validated. Serum samples were assayed for the presence of measles-specific IgG antibodies (family Paramyxoviridae, genus Morbillivirus, species Measles virus) using the HUMAN Worldwide Diagnostics Measles IgG ELISA kit (Wiesbaden, Germany; www.human.de). Measles-specific IgG in serum samples were 62% negative, 10% equivocal and 28% positive. In comparisons with matched serum, DBS results were 100% sensitive and 96.8% specific, and agreed in 92% cases. The authors concluded that their study establishes that the applied commercial ELISA test can be used to categorize individuals as having measles-specific IgG through analyses of DBS. The study was published in the September 2015 issue of the Journal of Medical Virology.

Neutropenia Found in Congenital And Adult Babesiosis nemia and thrombocytopenia are expected hematologic abnormalities in patients with acute babesiosis, whereas neutropenia is not usually considered a feature of this infection. Scientists determined the frequency of neutropenia in cases of congenital babesiosis based on a literature review and on the findings in an unreported case. Neutropenia was defined as an absolute neutrophil count of less than or equal to 1,800 neutrophils/μL for adults and less than 1,200 neutrophils/μL

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Year’s Top 100 Clinical Developments for infants. Four of five infants with congenital babesiosis whose neutrophil count was reported were neutropenic. Among 51 adult cases with babesiosis, 11 were neutropenic upon presentation, and 7 others developed neutropenia over the next 1–21 days. Consequently, a total of 18 (35%) of the adult patients with babesiosis had neutropenia. The study was published in the September 2015 issue of the American Journal of Clinical Pathology.

Liquid Biopsy Diagnostic Test for Colorectal Cancer Launched test has been launched that uses a patient’s blood sample to detect Kirsten rat sarcoma viral oncogene homolog (KRAS), a predictive biomarker for solid tumor cancers. KRAS mutations occur in approximately 40% of patients with colorectal cancer, and have been identified in high frequency in lung, pancreatic and other solid tumor cancers. Mutations in the KRAS gene have been shown to be predictive to resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, such as panitumumab and cetuximab. The liquid biopsy test is called Target Selector Assay that targets mutations in the KRAS gene and is a product of Biocept, Inc., (San Diego, CA, USA; www.biocept.com) a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer.

vantageous. Scientists used breast tissue biopsies and selected two parallel, adjacent sections from each – one was stained and the other left unstained. The unstained samples were analyzed using a SLIM module attached to a commercial phase contrast microscope to generate interferograms. Four interferograms were used to produce one quantitative image showing areas with different refractive properties in different colors. The boundary between tumors and the cells around them were clearly delineated, making it possible to assess whether the tumors were malignant or benign. The results demonstrated the potential and promise of SLIM for quantitative, label-free, and high-throughput diagnosis. The study was published on August 20, 2015, in the Journal of Biomedical Optics.

based rapid diagnostic tests. PositiveID Corporation (Delray Beach, FL, USA; www.psidcorp.com) has successfully detected C. difficile in less than 20 minutes on its “Firefly Dx” PCR breadboard prototype pathogen detection system. The assay, provided by partner GenArraytion, Inc. to PositiveID for testing, is a more comprehensive and specific test than many other available C. difficile assays, as it tests for the C. difficile chromosome in addition to Toxin-A and Toxin-B. PositiveID has also successfully detected the common HAI methicillin-resistant Staphylococcus aureus (MRSA) on its Firefly Dx prototype system, as well as the methicillin-susceptible Staphylococcus aureus (MSSA).

Successful C. difficile Test Expands Diagnostic Capability for Hospital-Acquired Infections

linical data demonstrated high sensitivity and specificity for the exosome-based liquid biopsy test in patients with non-small-cell lung cancer (NSCLC) suspected to be positive for echinoderm microtubule-associated protein-like 4 (EML4) gene fused to the anaplastic lymphoma kinase (ALK) gene. The data showed the ability of proprietary exosomal ribonucleic

more comprehensive Clostridium difficile test was added to the panel of pathogens successfully detected on a prototype system for PCR-

Liquid Biopsy Test Detects Non-Small-Cell Lung Cancer

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istology laboratories stand to benefit from the availability of a fully automated tissue embedder that was designed to eliminate the labor intensive necessity of manually orienting and embedding tissue specimens in paraffin blocks. Sakura Finetek Europe B.V. (Alphen aan den Rijn, The Netherlands; www.sakura.eu) introduced the Tissue-Tek AutoTEC a120 Automated Embedder at the September 5, 2015, European Congress of Pathology. The AutoTEC technology combined with the Paraform Sectionable Cassette System comprises a fully automated instrument, offering high-throughput of up to 120 cassettes per hour. The second-generation AutoTEC a120 features a cassette barcode reader for laboratory information system connectivity and traceability of specimen blocks. In addition, the input and output doors, the paraffin reservoir, and access to the base molds have been redesigned to provide improved ergonomics.

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MD HPLC, MD Mass Spec, and Software Receive IVDD CE-Marking he in vitro diagnostics device (IVDD) CE marking for the two high-performance instruments and software enables a combined system with the high accuracy of LC-MS to now be available to clinical laboratories in Europe. Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) has received the CE marking for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer, and ClinQuan MD software. The Prelude MD HPLC provides automated sample cleanup and two channels of HPLC separation for greater productivity and certainty from laboratory-developed clinical diagnostic tests. Developing IVD tests with the Endura MD MS provides excellent sensitivity, quantitative performance, and robustness with built-in usability to help deliver more value and worry-free results. The products were exhibited at the 2nd Annual European Conference on Clinical Mass Spectrometry, MSACL EU 2015 (September 8–11, Salzburg, Austria).

Breast Cancer Diagnosis Uses Spatial Light Interference Microscopy patial Light Interference Microscopy (SLIM) has been used to determine whether breast tissue lesions are cancerous, as this quantitative, labelfree, and high-throughput diagnosis method is highly ad-

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Annual Review 2015 acid plus cell-free DNA (cfDNA) platform to detect with high sensitivity epidermal growth factor receptor (EGFR) activating mutations and the EGFR T790M resistance mutation in blood plasma of patients with NSCLC. The test demonstrated the ability to determine the variant-specific expression profile of EML4-ALK fusion transcripts in plasma samples from NSCLC patients with known ALK tissue status by fluorescence in situ hybridization. In the study, Exosome Diagnostics, Inc., (Cambridge, MA, USA; www.exosomedx.com) used its ExoDx Solid Tumor mutation detection panel. The study was presented at the 16th World Conference on Lung Cancer held September 6–9, 2015, in Denver (CO, USA).

OCTOBER Low-Cost Blood Test May Enable Screening for Increased Bleeding Risk After Injury rom a proof-of-concept, pre-validation study, researchers have concluded that the admission hematocrit (AH) would likely provide a reliable predictor of increased bleeding risk in pediatric trauma patients. In examining medical records of all patients who presented to a level-1 pediatric trauma center, the researchers found that an AH of 35-or-less was able to identify children requiring intervention for bleeding, up to 67 hours after arrival. The results showed a significant difference in AH between patients who subsequently required a transfusion and those who did not. The cutoff figure of 35-or-less had a 94% sensitivity, 77% specificity, and 99.9% negative predictive value, indicating that use of this cutoff provides a reliable screening tool. The study, by Golden J et al., was published in the October 2015 issue of the Journal of Trauma and Acute Care Surgery.

Emergency-Use Listed Kit Provides Rapid Diagnostic Test for Ebolavirus chromatographic immunoassay for Zaire ebolavirus has now qualified as eligible for procurement through the World Health Organization (WHO)’s “Emergency Use Assessment and Listing (EUAL)” program. In response to WHO’s request to diagnostic medical device companies to develop a rapid in vitro diagnostic test for Ebolavirus disease, SD Biosensor, Inc. (GyeongGi-do, Republic of Korea; www.sd biosensor.com) has completed development and six months of official WHO clinical evaluation for its SD Q Line Ebola Zaire Ag assay. The kit uses 3 mouse monoclonal antibodies specific for Zaire Ebolavirus antigens: glycoprotein(GP), nucleoprotein(NP), viral matrix protein(VP40). The high-quality kit tests samples of whole blood, plasma, or serum: sensitivity on whole blood and plasma (n=126) 84.9% (95% CI) (78.6–91.2); specificity on whole blood and plasma (n=289) 99.7 % (95% CI) (99.1–100.0).

On-Chip Optical Sensing Technique Detects Multiple Flu Strains iophysicists have described a novel method to perform diagnostic assays for multiple strains of influenza virus on a small, dedicated chip. They demonstrated a novel application of a principle called wavelength division multiplexing. By superimposing multiple wavelengths of light in an optical waveguide on a chip, they were able to create wavelength-dependent spot patterns in an intersecting fluidic channel. The team tested the device using three different influenza subtypes labeled with different fluorescent markers. Virus particles labeled with fluorescent markers give distinctive signals as they pass through the fluidic channel depending on which wavelength of light the markers absorb. The study was published on October 6, 2015, in

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the journal Proceedings of the National Academy of Sciences of the United States of America (PNAS).

Quick Test Minimizes Unnecessary Primary Care Antibiotic Prescribing -reactive protein (CRP) is a biomarker in blood which indicates the presence of inflammation, and the amount of CRP in the body gives an indication of the severity of an infection. Low levels of CRP are indicative of viral or self-limiting bacterial infections, and high levels indicate serious infection. After undergoing a clinical scoring system, each patient’s CRP levels in a study were measured at the point of care using the Afinion CRP test, a rapid in vitro diagnostic assay for quantitative determination of CRP (Alere; Waltham, MA, USA; www.alere.com). Only 13% of these patients needed antibiotic treatment as the CRP POC test had concluded higher CRP levels. The study was presented at the Royal College of General Practitioners (RCGP) Annual Conference held October 1–3, 2015, in Glasgow (UK).

Novel Urinary Biomarkers May Indicate Adrenal Cancer nalysis of urine samples from patients with adrenal cancer has identified four biochemicals that when measured together can distinguish malignant from benign adrenal tumors. Scientists obtained urine specimens from patients with adrenal cortical carcinoma and benign adrenal tumors and ran a global analysis. Sixty-seven biochemical features discriminated cancer from benign tumors in these samples, but only four specific metabolites could be considered as biomarkers for cancer: creatinine riboside, tryptophan, Nε, Nε, Nε-trimethyllysine, and 3-methylhistidine. When these were present in characteristic patterns in urine samples, they were highly sensitive and specific for carcinoma. The metabolites could successfully identify cancer in 94.7% of cases and rule out the disease 82.6 % of the time. The study was presented at the Annual Clinical Congress of the American College of Surgeons held October 4–6, 2015, in Chicago (IL, USA; www.facs.org).

Simplexa Direct Test Includes 53 New Virus Strains he Simplexa test kit for select virus strains can detect 92 influenza and respiratory syncytial virus (RSV) virus strains – more than any other officially cleared molecular test kit. These include all four influenza strains that global health experts recommend be included in vaccines during the northern hemisphere’s 2015-2016 influenza season: A/Switzerland/9715293/2013 (H3N2)-like virus; A/California/7/2009 (H1N1)-like virus, B/Phuket/3073/2013like virus, and B/Brisbane/60/2008-like virus. The Simplexa Flu A/B & RSV Direct kit (Quest Diagnostics; Madison, NJ, USA; www.QuestDiagnostics.com) on the 3M Integrated Cycler (Focus diagnostics; Cypress, CA, USA; www.focusdx.com) is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) molecular test for the in vitro qualitative detection and differentiation of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) ribonucleic acid (RNA from patients with signs and symptoms of respiratory tract infection.

5-Gene Panel Confirmed as Diagnostic for High-Risk Pediatric Rhabdomyosarcoma paper confirmed the usefulness of a five-gene panel for identifying children with a high risk form of the muscle cancer rhabdomyosarcoma (RMS). In the current study, investigators profiled MG5 gene expression in samples taken from patients from the

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Year’s Top 100 Clinical Developments D9803 study of children with intermediate-risk RMS. Results revealed that the MG5 signature score showed a significant correlation with overall and failure-free survival. The MG5 test sorted fusion-negative patients into two distinct groups, based on the activity of the five genes. Patients with high scores had significantly worse survival chances than those with low scores, suggesting the test could ultimately be included in assessment of children with RMS. The paper was published in the October 15, 2015, online edition of the journal Clinical Cancer Research.

have been linked to prostate cancer. Results revealed that patients with a specific mutation or an increase in the number of copies of the AR gene were 7.8 times less likely to have a reduction of more than 90% in their PSA levels. The study also found that in about 15% of men given abiraterone who did not have either genetic aberration before starting treatment, it was acquired as resistance appeared and the drug stopped working. The study was published in the November 4, 2015, online edition of the journal Science Translational Medicine.

System Portfolio Includes High Medical Value Virology Assays

Respiratory Pathogen Diagnostic Panel Now Certified for Use in Europe E marking has been granted for a diagnostic panel that incorporates tests for 21 clinicallyrelevant viral and bacterial respiratory pathogens into a single closed microtiter plate well. The wide range of the Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) NxTAG Respiratory Pathogen Panel also includes such atypical bacteria as Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila. The NxTAG panel was designed for use with the Luminex MAGPIX instrument, which operates with fluorescent markers and magnetic microbeads. Each sample to be tested requires only minutes of hands-on time with no upstream reagent preparation. Simplified workflow allows extracted samples to be added directly to preplated, lyophilized reagents. The wells are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX instrument. Total turnaround time is just over three hours for 96 samples.

irology assays offer the latest generation of performance with dual target technology for Human immunodeficiency virus 1 (HIV-1) and dual probe technology for Hepatitis C virus (HCV). All of the assays can run simultaneously on the cobas 4800 System (Roche Molecular Diagnostics; Basel, Switzerland; http://molecular.roche.com) with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System has a

menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory. The assays run with two different sample processing volumes for HIV-1 and HCV (200 μL and 400 μL) and only 400 μL for HCV genotyping test. The cobas HIV-1 is built upon the dual-target assay design and the test simultaneously amplifies and detects two separate regions of the HIV-1 genome.

Blood Samples Analysis Monitors Colorectal Cancer Chemotherapy Response irculating cell-free DNA (cfDNA) collected from plasma of colorectal cancer patients may represent a less invasive approach to tracking biomarkers of interest longitudinally and at progression. Scientists enrolled patients with refractory B-Raf protooncogene, serine/threonine kinase (BRAF)-mutated metastatic colorectal cancer (mCRC) onto a phase I clinical trial of vemurafenib with irinotecan and cetuximab. Circulating cell-free DNA (cfDNA) was extracted from plasma and analyzed. Among the six patients with partial responses radiographically, the median reduction

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NOVEMBER Simple Blood Test Recommended for Pancreatic Cancer Patients largest-of-its-kind study has found that few pancreatic cancer (PC) patients undergo a key tumor-marker blood test and concluded that all PC patients should at diagnosis take this widely available test, which was found to be especially important for early-stage patients. The study showed that taking the test for tumor marker CA 19-9 at PC diagnosis can help predict whether patients are likely to have a better or worse outcome than average and help guide treatment accordingly. People who tested positive for elevated CA 19-9 levels tend to do worse than others, but if they are candidates for surgery and have chemotherapy prior to surgery, this personalized treatment sequence eliminates the negative effect. The findings were presented at the Western Surgical Association 2015 Annual Meeting (Napa Valley, CA, USA; November 7–10).

Analysis of Circulating DNA Predicts Prostate Cancer’s Development of Drug Resistance nalysis of prostate cancer DNA circulating in the bloodstream identifies a mutation that indicates whether the tumor will become resistant to the drug-of-choice abiraterone. Investigators developed a targeted next-generation sequencing approach amenable to plasma DNA, which covered all androgen receptor (AR) coding bases and genomic regions that

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Annual Review 2015 from baseline of BRAFV600E allele was -98% two weeks after treatment initiation. For those with stable disease, the median change was -33%, significant when compared to those with partial responses. cfDNA was increasing at the time of progression in all patients and preceded progression in 67%. The study was presented at the International Conference on Molecular Targets and Cancer Therapeutics, held November 5–9, 2015, in Boston (MA, USA; www.aacr.org).

DNA in Blood Tracks Cancer Development and Response irculating tumor DNA (ctDNA) analysis can be used to track tumor burden and analyze cancer genomes noninvasively, but the extent to which it represents metastatic heterogeneity is unknown. Scientists carried out an analysis of eight tumor biopsies and nine plasma samples collected from a patient with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer treated with sequential target-

Year’s Top 100 Clinical Developments ed therapies (tamoxifen and trastuzumab, followed by lapatinib). They performed whole-exome followed by deep amplicon sequencing to validate and quantify several hundred somatic mutations. The results show that the DNA in the blood samples matched up with that from the biopsies and provided the first proof-of-principle that analyzing tumor DNA in the blood can accurately monitor cancer within the body. The study was published on November 4, 2015, in the journal Nature Communications.

Childhood Concussions Detected by Blood Test blood test has been developed that can detect even the most subtle signs of a concussion in children, correctly identifying the presence of traumatic brain injuries in the majority of cases. Investigators performed computerized tomography (CT) scans on children and compared the results of those scans with results from the blood test they developed. The study showed that the blood test detected symp-

toms of concussions, even when brain injuries were not visible on the CT scan. The biomarker this blood test looks for is known as glial fibrillary acidic protein (GFAP). Performance for detecting intracranial lesions at a GFAP cutoff level of 0.15 ng/mL yielded a sensitivity of 94%, a specificity of 47%, and a negative predictive value of 98%. The study was published in the November 2015 issue of the journal Academic Emergency Medicine.

Rheumatoid Arthritis Test Predicts Patient Response to Drugs diagnostic for measuring the severity of rheumatoid arthritis (RA) can help guide patient selection for biologic or non-biologic drugs by predicting their response. The multi-biomarker blood test for RA disease activity integrates the concentrations of 12 serum proteins into a single objective score. The study evaluated whether the Vectra DA score could be used to predict the optimal choice of second-line treatment for patients with RA who were incomplete responders to the immunosuppressant methotrexate (MTX). The findings demonstrated that in patients with early RA and incomplete response to MTX, the Vectra DA test predicted the relative efficacy of second-line treatment with triple therapy versus anti-TNF. Vectra DA is manufactured by Crescendo Bioscience (South San Francisco, CA, USA; www.vectrada.com). The study was presented at the American College of Rheumatology/Association of Rheumatology Health Professionals meeting being held November 7–11, 2015, in San Francisco (CA, USA).

New Fully-Integrated Chemistry Analyzer Targets International Needs state-of-the-art analyzer, the EKF Diagnostics (Cardiff, United Kingdom; www.ekfdiagnostics. com) Altair 240 clinical chemistry analyzer has been unveiled at the Düsseldorf (Germany), Medica 2015 biomedical instrumentation fair. The bench-top platform represents EKF Diagnostics’ first fully integrated chemistry system designed for the global market. EKF believes that the new Altair 240 clinical chemistry analyzer fulfills an international market need for a fully automated bench-top platform supported by Stanbio Chemistry (Boerne, TX, USA; www.stanbio.com) reagent menu. The analyzer can run up to 400 tests per hour with an optional ISE module. Dual reagent probes translate to higher throughput and faster turn-around times. Operating cost efficiencies are also realized through an integrated cuvette washing station, enabling the reuse of cuvettes, as well as continual 24-hour onboard cooling, which ensures most reagents have a 30day on board stability to minimize waste.

DECEMBER Influenza-Respiratory Virus Panel Launched for Idylla platform n automated, real-time polymerase chain reaction (PCR) based molecular diagnostics system has been launched for the diagnosis of respiratory infectious diseases. The platform covers the entire process from sample to result in a time frame of 35 to 150 minutes with less than 2 minutes hands-on time. The platform is applicable for a wide range of clinical sample types and can analyze both ribonucleic acid (RNA) and DNA. The Idylla Respiratory IFV-RSV Panel (Biocartis Group NV; Mechelen, Belgium; www. biocartis.com) is designed for the qualitative detection of nucleic acids of Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (RSV) subtype

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Year’s Top 100 Clinical Developments A and RSV subtype B from nasopharyngeal swabs of adult and pediatric patients.

Study Validates Use of Noninvasive Test for Defective Fetal Chromosomes

Breast Cancer Diagnostic Blood Test Introduced

H&E Tissue Staining Solution Sets New Standard in Histopathology

biomedical company has reported the successful validation of its qPCR (quantitative real-time PCR)-based noninvasive test for fetal genetic abnormalities. LifeCodexx AG (Konstanz, Germany; http://lifecodexx.com) announced that its qPCR-based PrenaTest had been successfully validated in a study of nearly 700 samples of maternal blood. Starting from the ninth week of pregnancy, the PrenaTest is able to determine trisomy 21, trisomies 21, 18, and 13, as well as gonosomal aneuploidies in blood samples from expectant mothers at risk for fetal aneuploidies. The test method of the PrenaTest is based on the analysis of cell-free DNA (cfDNA) in the pregnant woman’s blood. The data generated by the clinical validation study was presented on the occasion of the FMF (Fetal Medicine Foundation) Advances Course held December 5–6, 2015, in London (UK).

blood test for breast cancer diagnosis in women with questionable mammographic findings and/or dense breast tissue is due for release in early 2016. Clinical data supporting the effectiveness of the Provista Diagnostics, Inc. (New York, NY, USA; www.provistadx. com) Videssa Breast assay was presented on December 3, 2015, at the 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America in Chicago (RSNA; IL, USA). In combination with clinical and radiological evaluations, Videssa Breast was designed to accurately detect the presence or absence of invasive breast cancer/ductal carcinoma in situ (DCIS) and reduce unnecessary follow-up procedures. Videssa Breast is a protein-based blood test that can accurately detect the presence or absence of breast cancer by identifying biomarkers that are early warning signals of breast cancer.

hematoxylin and eosin (H&E) staining system provides exceptionally high tissue staining quality and efficiency that enhances patient care as well as lab technician safety. The VENTANA HE 600 staining system from Roche (Basel, Switzerland; www.roche.com) delivers fresh reagents on each individual slide without relying on user-supplied alcohol and deionized (DI) water, resulting in improved consistency and quality. This individual slide staining technology mitigates the risk of specimen cross-contamination that can occur with other technologies, helping to reduce patient misdiagnosis. Elimination of xylene and alcohol and utilization of ready-to-use reagents reduce technician exposure. Workflow is improved by eliminating the need to manually mix reagents and track product expiration dates. The system offers over 400 individual staining protocols and is highly customizable, allowing for laboratory and pathologist preferences and tissue variables.

Rapid Molecular Host-Response Assay May Improve Diagnosis of Sepsis microarray assay that measures classifier RNA transcript biomarkers in blood may help quickly differentiate sepsis from infection-negative systemic inflammation (INSI) in critically ill patients, according to a study. A team reported the discovery and validation of a molecular classifier consisting of 4 RNA transcripts, SeptiCyte Lab, which in several selected patient cohorts was able to diagnose sepsis more accurately than procalcitonin or clinical parameters, and more quickly than blood culture. The team used microarray analysis to measure RNA expression levels of thousands of genes in blood samples from a cohort of 74 patients with sepsis and 31 postsurgical patients with INSI, thereby identifying the four genes (CEACAM4, LAMP1, PLA2G7, and PLAC8) that comprise the SeptiCyte Lab classifier. The study, by McHugh L et al., was published December 8, 2015, in the journal PLOS Medicine.

Tumor Sample Purity May Significantly Bias Genomic Analyses he proportion of normal cells, especially immune cells, intermixed with cancerous cells in a given tissue sample may significantly skew the results of genetic analyses. Scientists measured tumor purity in more than 10,000 [The] Cancer Genome Atlas samples representing 21 cancer types, and examined how purity might affect the reliability of three of the most common genomic methods used in cancer research: correlation, clustering, and differential analysis. In their analyses of samples of lung cancer, kidney cancer, and thyroid cancer, the group found that, if tumor purity were not taken into account, differential analysis could yield misleading results on the relative expression of proteins called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Cluster of Differentiation 86 (CD86), both important targets in cancer immunotherapy. The study was published on December 4, 2015, in the journal Nature Communications.

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Philips to Collaborate with Janssen On POC Neuropsychiatric Tests oyal Philips (Amsterdam, Netherlands; www. philips.com) has entered into a multiyear development agreement with Janssen Pharmaceutica NV (Beerse, Belgium; www.janssenbelgium.be) to develop a novel point-of-care (POC) blood test to improve the care of patients with neuropsychiatric disorders. The blood test is based on the Philips’ Minicare I20 for immunoassays, which consists of a handheld analyzer, dedicated software, and a single-use, disposable cartridge containing the application-specific test. Minicare is part of Philips’ Handheld Diagnostics business (Eindhoven, Netherlands), which will be expanding its production capacity in light of the new partnership. The collaboration unites Philips’ expertise in POC diagnostics and monitoring applications for hospital and home with Janssen’s strength in discovering and developing innovative solutions to treat brain disorders.

Affymetrix to Distribute Luminex’s Multiplexed Assay Platforms ffymetrix Inc. (Santa Clara, CA, USA; www. affymetrix.com) and Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) have announced their agreement under which eBioscience, a business unit of Affymetrix, will sell 3 Lumix xMAP-based instruments for multiplexed assays in specific countries in the Americas, Asia, and Europe, enabling laboratories to choose a platform that fits their throughput and flexibility needs. Together with Luminex’s MAGPIX, Luminex 200, and FLEXMAP 3D instrument platforms, Affymetrix will sell its ProcartaPlex multiplexed immunoassays and QuantiGene Plex multiplexed quantitative gene expression assays, offering complete solutions in drug discovery and development, immuno-oncology, and translational research. All three Lumix instruments run multiplexed assays for proteins or nucleic acids, whether kit-based or lab-developed.

Bio-Rad Extends Exclusive Distribution of Two Infectious Disease Tests by Beckman io-Rad Laboratories, Inc. (Hercules, CA, USA; www.bio-rad.com), a global provider of life science research and clinical diagnostic products, and clinical diagnostics leader Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter.com), announced that Bio-Rad is extending its agreement with Beckman Coulter and has named the company exclusive global distributor of Bio-Rad’s Access HIV combo assay and Access Hepatitis C virus (HCV) assay in select geographies. The 10-year exclusive distribution rights agreement is part of an extension of the manufacturing

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and supply agreement that began nearly 20 years ago for blood virus and infectious disease immunodiagnostic testing.

Alere Strengthens Core Business With Two Strategic Transactions lere Inc. (Waltham, MA, USA; www.alere. com), a leader in rapid diagnostics, continued to strengthen focus on its core business strategy through an agreement to sell BBI Group and an acquisition of US Diagnostics (Huntsville, AL, USA; http:// usdiagnostics.com). On July 2, 2015, Alere signed an agreement to sell its BBI business to the UK-based firm Exponent Private Equity LLP for a total purchase price equivalent to approximately USD 164 million. In November 2015, Alere completed its divestiture from BBI. In the second transaction, Alere has acquired substantially all assets of US Diagnostics (US-D) for USD 60 million in cash. US-D is a leading provider of drug testing devices and is currently a distributor of Alere Toxicology products.

Qiagen in Korean Diagnostics Alliance n a collaboration, Seegene Inc. (Seoul, Republic of Korea; www.seegene.com) will use its proprietary next-generation qPCR technology in developing new multiplex assays for the flag-ship platform of Qiagen NV (Venlo, Netherlands and Hilden, Germany; www.qiagen.com). Seegene will develop a menu of multiplex assay panels for the modular QIAsymphony RGQ MDx automation platform, the first project being panels to profile infectious diseases. Seegene’s technologies for multiplexed real-time PCR analysis enable simultaneous amplification of up to 20 target genes per tube in a single reaction, saving time, labor, and cost. QIAGEN will perform clinical validation studies and will market validated tests worldwide as QIAGEN-branded assays, beginning in Europe and Asia.

Thermo-IL Distribution Alliance to Advance Automated Hemostasis Diagnostics n exclusive-distribution agreement leads to a high-performance hemostatis work cell by connecting a laboratory automation system (LAS) from Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) with a hemostasis testing LAS from Instrumentation Laboratory (IL; Bedford, MA, USA; www.ilus.com). The agreement between IL and Thermo Fisher appoints IL as the exclusive worldwide distributor for the Thermo Scientific TCAutomation LAS in the field of hemostasis. IL will offer state-of-the-art “Hemostasis Lab Automation Work Cell” solutions, comprised of their ACL TOP 700/750 LASs integrated with the TCAutomation LAS. Hemostasis labs considering automation can now rely on leading hemostasis expertise of IL coupled with leading automation expertise of Thermo Fisher, to provide them with tailored LAS solutions for standardization and workload management.

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Roche Acquires Microbial Diagnostics Developer eneWEAVE BioSciences, Inc. (Los Gatos, CA, USA; www.geneweave.com) and Roche (Basel, Switzerland; www.roche.com) have announced that Roche will purchase the privately held de-

veloper of clinical microbiology diagnostics solutions for an upfront payment of 190 million USD and up to 235 million USD in contingent product related milestones. Under the terms of the agreement, GeneWEAVE will be integrated into Roche Molecular Diagnostics. GeneWeave’s major innovations are based on its proprietary Smarticles technology. Smarticles are DNA-delivery bio-particles combined with GeneWEAVE-designed DNA molecules that cause live bacteria to produce light. Smarticles are engineered to specifically target a species, genus, or family of bacteria. They bind to their target and deliver a DNA molecule designed by GeneWEAVE that causes the bacteria to express luciferase – a molecule that produces light.

Unilabs to Use Finnish Molecular Diagnostic Tests In Sweden and Norway Finnish molecular diagnostics company specialized in the development of diagnostics solutions for infectious diseases, and Unilabs, an industry-leading diagnostics service provider announced an agreement covering the supply of Amplidiag products. Unilabs (Geneva, Switzerland; www.unilabs.com) operates laboratory and medical diagnostic imaging facilities in 12 countries. The company announced the signing of a four-year agreement with Mobidiag Ltd. (Espoo, Finland; www.mobidiag.com) for the supply of Mobidiag’s Amplidiag molecular diagnostic tests for Unilab’s facilities in Sweden and Norway. The Amplidiag Bacterial GE test utilizes well-established qPCR (qualitative polymerase chain reaction) technology for the rapid qualitative detection of eight gastroenteritis-causing bacteria directly from stool samples without requiring preculturing of the samples.

Erba Mannheim Acquires French Analyzer Concern rba Lachema, Erba Mannheim (Mannheim, Germany; http://erbamannheim.com), through its Czech subsidiary, has expanded its portfolio by acquiring Maxmat SA, France, a company emphasizing development and manufacturing of medical laboratory devices based on original patented technologies. On September 21, 2015, Erba Mannheim successfully completed its acquisition of Maxmat, whose blood analyzers are used in clinical laboratories in Western Europe, the USA, and other countries. Maxmat SA France has been renamed to Erba Diagnostics France SARL (Montpellie, France; www.erbafrance.com). Erba Diagnostics France will benefit the entire Erba group with its capabilities and knowhow in the field of design and development of analyzers that perform multiple functions in a laboratory spanning different segments of biochemistry, hemostasis, and immunology.

Transasia Bio-Medicals Receives Global Growth Company Award eading in vitro diagnostics (IVD) company Transasia Bio-Medicals Ltd. (Mumbai, India; www.transasia.co.in) has been selected as “Global Growth Company-2014” by the World Economic Forum (WEF), comprising top global enterprises. After an evaluation process, Transasia Bio-Medicals was selected as one of the most dynamic and high-growth companies, and considered a trailblazer, shaper, and innovator committed to improving the state of the world. This award also recognizes the strength of Transasia’s leadership ability. The award was presented on November 5, 2014, at the India Economic Summit held in New Delhi, organized by WEF along with the Confederation of Indian Industry (CII). The summit facilitated the meeting of the WEF’s global multi-stakeholder community with the new government, to together define and help shape the country’s next phase of transformation.

LabMedica International December/2015-January/2016

ALPHABETICAL LISTING OF COMPANIES WORLD’S IN VITRO DIAGNOSTICS COMPANIES

AbD Serotec 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 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.

AB Sciex

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

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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.

ABS Advanced Biomedical Systems Italy • Milan Tel: (39) 2-925-904-41 Web: absdiag.it E-mail: info@absdiag.com Focuses mainly on supplying diagnostic products, rapid test (IVD) kits and instruments to pediatric offices.

Accriva Diagnostics USA • San Diego, CA Tel: (1) 858-263-2501 Web: accriva.com E-mail: intlcustomerservice@ accriva.com Develops, manufactures, and markets products in four categories: Hemochron point-ofcare coagulation instruments and reagents; IRMA TRUpoint Blood Analysis System for blood gas and electrolyte testing; skin incision products including tenderfoot, Tenderlett and Surgicutt; and the ProTime Microcoagulation System for prothrombin time testing.

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.

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.

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

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. SEE AD ON PAGE 44

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.

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

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

Advanced Instruments USA • Norwood, MA Tel: (1) 781-320-9000 Web: aicompanies.com E-mail: 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. SEE AD ON PAGES 6, 20

Aeon Technology China • Shenzhen Tel: (86) 755-8618-2140 Web: aeon-med.com E-mail: raymond@aeon-med.com

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.

Designs and produces clinical diagnostic equipment, as well as containers and disposables.

Adam Equipment

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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

disease, cardiac, and tumor markers. Recently added products include a blood glucose monitoring system, urinalysis reagent strips, thermometers, and blood pressure monitors.

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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.

UK • Oxford Tel: (44) 1865-852-700 Web: abdserotec.com E-mail: `support_uk@biorad.com Develops and manufactures antibodies, immunological reagents, and custom monoclonal antibodies, as well as offering large- and small-scale antibody production and conjugation services.

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LabMedica 300 Manufactures fume hoods, enclosures, and workstations designed to protect the operator or process from potentially harmful fumes, vapors, gases, and particulate.

Develops rapid point-of-care diagnostics that focus on infectious disease, cardiology, oncology, drugs of abuse, and women's health.

Alfa Scientific Designs 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.

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.

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Alfa Wassermann

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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Alere USA • Waltham, MA Tel: (44) 1234-759900 Web: alere.com

Italy • Milan Tel: (39) 02-64-222-1 Web: alfawassermann.it E-mail: info@alfawassermann.it Develops and manufactures instruments and products designed for use in diagnostic applications in clinical chemistry laboratories.

Alifax Italy • Padua Tel: (39) 49-099-2000 Web: alifax.com E-mail: info@alifax.com Specializes in diagnostics, and offers the biotechnology field a diagnostic as well as a medical line, along with laboratory equipment and disposables.

All.Diag France • Strasbourg Tel: (33) 3 88 78 80 88 Web: alldiag.com E-mail: info@alldiag.com Specializes in the development and the distribution of rapid diagnostic tests, both in the human and veterinary fields.

Alpha Laboratories 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.

American Biochemical & Pharmaceuticals 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

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

AMS Italy • Rome Tel: (39) 0774-354441 Web: ams-analyzers.com E-mail: info@ams-analyzers.com Produces and exports automatic analyzers for clinical chemistry and nephelometric assays, with a wide range of products that fully adapts to the needs of different sized laboratories.

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.

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 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. Visit us at

Apex Biotechnology 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.

Web: astechcorp.co.jp Designs and produces scientific instruments such as generators and microprocessor-controlled matching network products.

Arista Biologicals

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.

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

Artel 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.

Asan Pharmaceutical 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.

Astell Scientific

Astra Biotech 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.

Atlas Link USA • Manassas, VA Tel: (1) 703-366-3851 Web: atlaslink-inc.com E-mail: info@atlaslinkinc.com Manufactures IVD test kits and supplies generic and branded pharmaceuticals, medical disposables, medical, and laboratory equipment, and blood glucose and cholesterol monitoring products.

Audit Diagnostics

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.

Ireland • Carrigtwohill, Co. Cork Tel: (353) 21-453-3652 Web: auditdiagnostics.ie E-mail: info@auditdiagnostics.ie Provides clinical chemistry reagents and analyzers. Products include a range of liquid ready-to-use reagents for all types of routine analyzers from semiautomated to fully automated systems. Other products include a Direct Replacement Bar-Coded reagent line for the Hitachi, Olympus, Kone, and Express range of Analyzers.

Astech

AUDIT MicroControls

Japan • Tokyo Tel: (81) 03-3366-0811

USA • Eatonton, GA Tel: (1) 866-252-8348

Aspyra

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LabMedica 300 Web: auditmicro.com E-mail: info@auditmicro.com Supplies daily quality control and calibration verification/linearity materials to clinical laboratories worldwide.

Autobio Diagnostics

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BD Diagnostics

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.

USA • Franklin Lakes, NJ Tel: (1) 201-847-6800 Web: bd.com/ds Manufactures and sells medical supplies, devices, laboratory 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 B&E Scientific

China • Hunan

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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.

Benchmark Scientific

Bio Focus

USA • Edison, NJ 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.

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. UK • Birmingham Tel: (44) 0-121-456-9500 Web: bindingsite.com E-mail: info@bindingsite.co.uk Specializes in providing antiserum protein and immunoglobulin antisera and conjugates, disease state plasma especially autoimmune and myeloma specificities, purified proteins including myeloma, HBsAg, CRP, SHBG and Arotec Diagnostics Autoimmune Antigens and clinical patient samples for use in the investigation of human and veterinary diseases.

A BioMerieux Company 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 • 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. SEE AD ON PAGE 33

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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. SEE AD ON PAGE 43

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.

Biokit Spain • Barcelona Tel: (34) 93-860-9000 Web: biokit.com

E-mail: biokit@biokit.com Specializes in the research, development, manufacture, and distribution of immunoassays and systems in the fields of infectious diseases and serum proteins, among others.

Biohit HealthCare

Bio-Rad Laboratories

Binding Site, The

BioFire Diagnostics

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Korea • Uiwang Tel: (82) 31-457-5870 Web: biofocus.co.kr E-mail: info@biofocus.co.kr Manufactures products for IVD and point-of-care testing.

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AVE Science & Technology

USA • Bensenville, IL Tel: (1) 630-974-5159 Web: besic.com E-mail: info@besic.com Develops and markets a wide range of clinical diagnostic products.

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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.

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.

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AutoGenomics

Awareness Technology

BBInternational

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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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.

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.

SEE AD ON PAGE 38

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

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LabMedica 300 sells products designed to detect diseases in the areas of cancer, cardiology, fertility, gastroenterology, diabetes, allergy, and infectious diseases.

BioMerieux

Bioneer Korea • Daejeon Tel: (82) 42-930-8777 Web: bioneer.com E-mail: sales@bioneer.com Develops molecular biology products and technologies including oligonucleotides, thermostable polymerases, and instruments of gene manipulation (automatic nucleic acid extractor, thermal cycler, realtime QPCR instruments and DNA sequencer).

BioPorto Diagnostics

BIORON Diagnostics Germany • Ludwigshafen

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BioSampling Systems France • Paris Tel: (33) 1-34-30-42-00 Web: biosamplingsystems.com 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.

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.

Biosino Bio-Technology & Science China • Beijing Tel: (86) 10-6972-2840 Web: zhongsheng.com.cn E-mail: biosino@ zhongsheng.com.cn Develops, manufactures, and markets clinical chemistry reagents. Products include one-step rapid test kits, clinical chemistry reagent kits, as well as immunology reagent kits.

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.

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 rele-

vant 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 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.

struments and reagents for human and veterinary medicine.

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.

Biotron Diagnostics 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 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 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 • Stockholm Tel: (46) 8-7447700 Web: boule.se Manufactures automatic blood cell counters/hematology in-

Callegari Italy • Parma Tel: (39) 05-21-273274 Web: callegari1930.com Provides a range of userfriendly instruments for pointof-care testing in various medical applications.

CANDOR Bioscience 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.

Canterbury Scientific 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 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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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.

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.

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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.

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

Caretium Medical Instruments 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

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LabMedica 300 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

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 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 • Kronburg Tel: (49) 8394-257929 Web: cellasys.com 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

ucts including a range of retractable and auto-retractable safety syringes designed to be unique, cost effective, and simple to use.

Certest Biotec

Clinical Diagnostic Solutions

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. China • Beijing Tel: (86) 10-5871-7511 Web: chemclin.com E-mail: BD@chemclin.com Specializes in the development, manufacture, and distribution of IVD reagents and instruments.

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

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.

Visit us at

MEDLAB

Stand Z4G20

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

Cepheid

Chronolab

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.

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.

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.

Corgenix

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.

Chemtron Biotech

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.

Korea • Cheonan Tel: (82) 41-551-0600 Web: ceragemmedisys.com E-mail: overseas@ ceragemmedisys.com Designs and manufactures

CLONIT

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.

Chemclin Biotech

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.

Ceragem Medisys

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

Copan Diagnostics

CLA Europe UK • Thame, Oxfordshire Tel: (44) 1844-355472 Web: claeurope.eu E-mail: info@claeurope.eu Produces pharmaceutical prod-

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CPC Diagnostics 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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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, health care, and eye care.

blood diagnostics products including POC equipment for measuring blood glucose, hemoglobin, lactate, HbA1c, CRP, and hematocrit.

SEE AD ON PAGE 40

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.

CTK Biotech USA • San Diego, CA

LabMedica 300 Tel: (1) 858-457-8698 Web: ctkbiotech.com E-mail: info@ctkbiotech.com Develops and manufactures innovative rapid tests, ELISA kits, and external controls.

daangenel.com Produces and services IVD products, including PCR, TRF, ELISA and RAPID diagnostic kits and equipment.

Cytocell

An Agilent Technologies Company

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

Dako Denmark • Glostrup Tel: (45) 44-85-95-00 Web: dako.com E-mail: info.dk@dako.com Specializes in cancer research, new discoveries in medicine, clinical diagnostics, disease management and personalized medicine. 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.

D-tek

Delcon

Da An Gene China • Guangzhou Tel: (86) 20-3229-0789-205 Web: http://en.daangene.com E-mail: marketing@

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

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 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.

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.

USA • South San Francisco, CA Tel: (1) 650-246-6400 Web: diadexus.com DiaDexus’ lead product, the PLAC test, is a blood test that measures the concentration of lipoprotein-associated phospholipase A2 (Lp-PLA2), a novel risk factor for coronary heart disease and ischemic stroke.

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.

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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, and along with liquid substrates and stabilizers.

Das

Denka Seiken

Diadexus

SEE AD ON PAGE 36

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.

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.

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SEE AD ON PAGE 40

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

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

E-mail: customerservice@ diamedix.com Focuses on the development of integrated instrument and reagent systems for both autoimmune and infectious disease detection.

Diametra 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.

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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.

E-mail: marketing@deltalab.es Manufactures a range of containers and disposables, along with pipettes and liquid handling systems.

SEE AD ON PAGES 21, 23

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.

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.

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.

Diamedix An Erba Mannheim Company USA • Miami, FL Tel:(1) 305-324-2300 Web: diamedix.com

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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 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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LabMedica 300

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.

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DiaSys Diagnostic Systems Germany • Holzheim Tel: (49) 6432-9146-0

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.

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DIAsource ImmunoAssays

Web: diasys-diagnostics.com E-mail: info@diasys.de Develops, manufactures, and 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.

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

SEE AD ON PAGE 8

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

Diesse Diagnostica Senese

Dirui Industrial

DNA Genotek

Dometic Medical Systems

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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.

Dymind Biotech China • Shenzhen Tel: (86) 0755-2600-8015 Web: dymind.com.cn E-mail: info@dymind.com.cn Specializes in the manufacture and sales of products that include in vitro diagnostic medical devices and home ventilators. SEE AD ON PAGE 34

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USA • Chantilly, VA Tel: (1) 703-803-1241 Web: dynextechnologies.com E-mail: productinfo@ dynextechnologies.com Designs and manufactures fully-automated ELISA microplate workstations, laboratory instruments and associated consumables and accessories.

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

info@elitechgroup.com Offers a range of products for in vitro diagnostics in clinical chemistry, hemostasis, microbiology, immunology, and electrophoresis.

EMD Millipore 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.

Emperor Electronic Technology 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.

EKF Diagnostics UK • Cardiff Tel: (44) 29-20-710570 Web: ekfdiagnostics.com E-mail: lewiscoburn@ ekfdiagnostics.com Develops and manufactures point-of-care and central lab products, specializing in analyzers for hemoglobin and HbA1c. SEE AD ON PAGE 41

ELGA LabWater UK • High Wycombe 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.

ELITech Group France • Paris Tel: (33) 0-1-41-45-07-10 Web: elitechgroup.com E-mail:

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

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USA • Springfield, NJ Tel: (1) 973-564-7555 Web: drg-international.com E-mail: marketing@ drg-international.com Manufactures and distributes enzyme immunoassays, rapid tests, saliva tests, tumor tests, radio immunoassays, and lab equipment.

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Luxembourg • Hosingen Tel: (352) 920-731-1 Web: dometic.nl E-mail: info@dometic.nl Offers special refrigerators, deep freezers, storage, transport concepts for laboratory, medicine, research, biotechnology, and life sciences.

DRG International

Dynex Technologies

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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.

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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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.

Dragon Laboratory Instruments

SEE AD ON PAGES 13, 15

Eppendorf Germany • Hamburg Tel: (49) 4053-8010 Web: eppendorf.com E-mail: eppendorf@eppendorf.de Develops, manufactures, and

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LabMedica 300 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 Portugal • Santa Maria da Feira Tel: (351) 256-330350 Web: esteriplas.net E-mail: geral@esteriplas.mail.pt Develops, manufactures, and distributes a wide range of hospital, laboratory, safety, and hygienic products including containers and disposables, as well as pipettes, liquid handling systems, and sterilization options.

Euro-Diagnostica 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.

EuroClone Italy • Milan Tel: (39) 02-38195-1 Web: euroclone.net E-mail: export@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.

Eurospital

Fosun Diagnostics

Globe Scientific

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.

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.

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.

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.

Fine Care Biosystems 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.

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.

Fluorogenics UK • Salisbury Tel: (44) 7719-372198 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.

Euroimmun

Focus Diagnostics USA • Cypress, CA Tel: (1) 562-240-6500 Web: focusdx.com Develops and provides specialized testing services, diagnostic products and anti-infective surveillance and consultative services for the diagnosis, treatment and management of infectious diseases.

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Germany • Lübeck Tel: (49) 451 58 55 0 Web: euroimmun.com E-mail: euroimmun@ euroimmun.de Designs and manufactures products for autoimmune and infectious disease diagnostics, allergy and gene analytics. Products include indirect immunofluorescence, ELISA, immunoblot, radioimmunoassay, microarray, and automation technologies.

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Fujirebio Diagnostics 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.

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 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

GeneReach Biotechnology 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.

Genius Electronics China • Shenzhen Tel: (86) 755-2683-5560 Web: geniusmedica.com E-mail: international@ geniusmedica.com Designs and produces medical instruments focused on medicine inspection.

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

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 high-risk HPV types in one reaction.

Getein Biotechnology China • Nanjing Tel: (86) 25-6856-9011 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. LINKXPRESS COM

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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.

Greiner Diagnostic Germany • Bahlingen Tel: (49) 76-6391-490 Web: greiner-diagnostic.com Specializes in developing, manufacturing and marketing a range of clinical diagnostic as-

LabMedica 300 says 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.

Health-Chem Diagnostics USA • Pompano Beach, FL Tel: (1) 954-979-3845 Web: healthchemdiagnostics.com E-mail: info@healthchemdiagnostics.com Manufactures diagnostic tests for clinical chemistry, POC, immunology, microbiology, and hematology.

Helena Laboratories USA • Beaumont, TX Tel: (1) 409-842-3714

Hecht - Assistent Germany • Sondheim Tel: (49) 9779-808-0 Web: hecht-assistent.eu 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.

Web: helena.com Provides specialized, sensitive bedside hemostasis diagnostics for intraoperative platelet aggregation and heparin monitoring.

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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.

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.

Hongqi Optical Instrument Technology

products for IVD and point-ofcare testing.

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.

Hycor Biomedical

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

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.

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.

Hologic

Human Diagnostics

Hitachi Aloka Medical

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.

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 Tel: (82) 31-478-8591 Web: humasis.com Develops and manufactures

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 Manufactures and markets high-quality immunological reagents for research and industrial applications. Products include cardiac markers, hormones and toxins, human proteins, neuroscience, infectious and autoimmune disease reagents.

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.

Immco Diagnostics A Trinity Biotech Company USA • Buffalo, NY Tel: (1) 716-691-0091 Web: immcodiagnostics.com E-mail: info@immco.com Focuses on autoimmunity, as a clinical reference laboratory and manufacturer of diagnostic test kits. Product applications include endocrinology, gastroenterology, immunogenetics, immunology, neurology, rheumatology, dermatopathology, oral pathology, and hearing loss.

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 colorimetric microarray containing 10 DNA/ENA antigens.

Immunodiagnostic Systems UK • Boldon, Tyne and Wear Tel: (44) 191-519-0660 Web: idsplc.com E-mail: info.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.

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, bio-

Visit us at

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LabMedica 300 engineering, and Lab-on-a-chip 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) 800-955-9525 Web: instrumentationlaboratory.com E-mail: smccraven@ilww.com Develops, manufactures, and distributes a wide range of products and solutions for hemostasis testing needs, including the advanced ACL family of systems.

InTec Products 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

IWAKI Japan • Tokyo Tel: (81) 3-3254-2935 Web: iwakipumps.jp

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.

JS Medicina Electronica 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.

Kabe Labortechnik 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.

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: kamiyabiomedical.com E-mail: info@k-assay.com Supplies research and diagnostic tools including enzyme inhibitors, enzyme substrates, monoclonal antibodies and small molecules for apoptosis, multidrug resistance, signal transduction, cancer and cell biology research. The company also offers a line of clinical diagnostic and research immunoassay products for lipid assessment, coagulation, inflammation, diabetes, nutritional assessment, and serum pro-

LabMedica International December/2015-January/2016

tein measurement based on immunoturbidimetric technology.

Kartell Labware Italy • Milan Tel: (39) 2-900-121 Web: kartell.it E-mail: kartell@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

ers, needle incinerators, blood mixers, roller mixers, centrifuges, differential blood cell counters, vortex mixers, cyclo mixers, dry baths incubators, hematocrit digital centrifuges, and spring 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 analyzers for ESR, biochemistry, HbA1c, and elec-

trolytes, as well as turbidimeters for serum proteins.

Laboratoires Eurobio 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.

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

Denmark • Taastrup Tel: (45) 3927-1771 Web: kem-en-tec.com E-mail: support@kem-en-tec.com Supplies components used in immunoassays such as ELISA, blotting and tissue staining. The products are covered by five categories: liquid substrates, substrate tablets, buffers and stabilizers, enzymes, and avidin and streptavidin.

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 Sweden • Helsingborg Tel: (46) 42-32-40-00 Web: labex.com E-mail: reagents@labex.com Produces reagent systems for hematology instruments with or without leukocyte differentiation and supplies diagnostics and instruments to laboratories in hospitals, universities and the pharmaceutical industry.

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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.

Manufactures high-purity metering pumps, chemical delivery pumps, recirculation pumps and nonmetallic magnetic drive centrifugal pumps and systems.

SEE AD ON PAGE 44

Labline Equipments India • Gujarat Tel: (91) 265-3927448 Web: lablineindia.com E-mail: haresh@lablineindia.com Manufactures needle destroyLINKXPRESS COM

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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: 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

LabMedica 300 Develops and produces in vitro diagnostic test systems for the clinical and research laboratory markets.

Macherey-Nagel

Mast Group

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.

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.

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.

Magellan Biosciences

Master Diagnostica

LP Italiana 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.

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

LifeSign USA • Skillman, NJ 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.

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 and manufactures in vitro diagnostic reagents and instruments.

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.

LRE Medical Germany • Nordlingen Tel: (49) 0-9081-800-0 Web: esterline.com E-mail: info@lre.de Develops and manufactures medical and in vitro diagnostic (IVD) and life science products for handheld, POC, and laboratory markets.

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 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.

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

MagnaBioSciences 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.

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) 11-3088-6743 Web: magnusanalytics.com E-mail: sales@ magnusanalytics.com Manufactures microscopes and microscope optics for the clinical laboratory market.

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.

MDS Nordion Canada • Ottawa, ON Tel: (1) 613-592-2790 Web: mds.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.

blood, serum, plasma and urine. The blood gas analyzers measure PO2, PCO2 and pH and use a calibration method that eliminates gas tanks.

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Lobeck Medical

SEE AD ON PAGE 9

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

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

Finland • Kauniainen 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 POC tests for human healthcare.

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

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,

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LabMedica 300 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 semiautomated clinical chemistry analyzers, dry bath incubators, ELISA strip readers, electrolyte analyzers, and plate luminometers.

MicrobioLogics

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.

Midland BioProducts USA • Boone, IA Tel: (1) 515-432-5516 Web: midlandbio.com E-mail: sales@midlandbio.com Manufactures polyclonal antisera as a raw material for immunoturbidimetric assays of human plasma proteins, and also offers calibrator and control materials.

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

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,

SEE AD ON PAGES 36, 49

MPW Med. Instruments

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.

Nordic Biomarker 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.

Nova Biomedical USA • Waltham, MA Tel: (1) 781-894-0800 Web: novabiomedical.com E-mail: info@novabio.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.

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.

ment including incubators, deep freezers, dry heat sterilizers, ovens, centrifuges, water baths and water distillers, blood bank refrigerators, safety cabinets, and bench-top steam sterilizers.

NuAire

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.

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.

SEE AD ON PAGE 7

NovaTec Immundiagnostica Germany • Dietzenbach Tel: (49) 6074-4876-0 Web: novatec-id.com E-mail:

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 equip-

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, coagulation 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, bioMEMS (Micro-Electro-Mechanical Systems), electronics, chemistry, and optics, and have developed innovative products for life science research and point-of-care diagnostics.

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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 hand-held readers.

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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.

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 large-scale quantities of fine chemicals.

2 parameter analyzers to fully automated 22 parameter analyzers with a barcode reader and a 50-sample rack.

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Microlit

MP Biomedicals

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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.

used in diagnostic testing applications, as well as in research and process testing at pharmaceutical and biotechnology companies.

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Nihon Kohden 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

LabMedica International December/2015-January/2016

Oasis Diagnostics

Omega Diagnostics 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-

LabMedica 300 erance, autoimmune disease, and infectious disease.

Operon

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OraSure Technologies

Orgentec Diagnostika 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.

Orion Diagnostica

Orphee Medical

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

Paul Marienfeld Germany • LaudaKönigshofen Tel: (49) 0-9343-6270-0 Web: marienfeld-superior.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.

SEE AD ON PAGE 22

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 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.

Polymedco USA • Cortlandt Manor, NY Tel: (1) 914-739-5400 Web: polymedco.com Provides instruments and reagents for clinical chemistry and hematology, as well as POC tests for FOBT, cholesterol, diabetes, and bladder cancer detection.

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.

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.

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.

Quimica Clinica Aplicada 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.

Qiagen 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.

Pointe Scientific / MedTest USA • Canton, MI Tel: (1) 734-487-8300 Web: pointescientific.com

SEE AD ON PAGE 17

Quidel

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. SEE AD ON PAGE 52

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.

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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.

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.

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.

Tel: (1) 800-624-8380 Web: quantimetrix.com E-mail: sales@quantimetrix.com Develops and manufactures clinical diagnostic products including electrophoresis systems and diagnostic assays. Existing products include urinalysis, general chemistry and specialty chemistry controls, and whole blood controls. Recent products include Lipoprint, a LDL subfraction test system, as well as Glyco-Hemosure, a Hemoglobin A1c control.

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

Oyster Bay Pump Works

Peripheral Visions

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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.

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

E-mail: marketing@medtest.com Provides automated, fast, and cost-effective blood and urine testing solutions to small, medium, and large labs worldwide.

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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.

Ortho-Clinical Diagnostics

SEE AD ON PAGE 10

Quantimetrix

Radiometer Medical

USA • Redondo Beach, CA

Denmark • Bronshoj

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 an-

HEMATOLOGY REAGENTS FOR CELLCOUNTERS LABEX is a very experienced producer of reagents for various types of blood cell counters. All products are CE-marked and marketed world-wide through exclusive distributors. For further information about products, your local supplier or distribution partnership, please contact LABEX. LABEX REAGENS AB P.O. Box 22159 • SE-250 23 Helsingborg • SWEDEN Tel. +46 42 32 40 00 • Fax. +46 42 20 27 71 gert.johansson@labex.com

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LabMedica 300 alyzers, microplate readers, microplate washers, and coagulation analyzers.

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SEE AD ON PAGE 30

Reagena

Canada • Vancouver, BC Tel: (1) 604-456-6010 Web: responsebio.com E-mail: customersupport@ responsebio.com Focuses on an immunoassay platform that provides diagnostic information. RAMP tests are commercially available for two congestive heart failure markers, three cardiac markers used in the detection of heart attack, three infectious disease markers used in the detection of influenza A+B and RSV, environmental detection of West Nile virus and biodefense applications, including the detection of anthrax, ricin, smallpox, and botulinum toxin.

RNA Medical

Robonik India 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.

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.

SA Scientific 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.

Sakura Finetek Europe Netherlands • Alphen aan den Rijn Tel: (31) 88-592-00-00 Web: sakuraeu.com

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.

Sebia 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 cap-

illary electrophoresis and hemoglobin assays.

Sekisui Diagnostics 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.

ick 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.

Shenzhen New Industries Biomedical Engineering (SNIBE)

Serosep

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.

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.

Ireland • Annacoty, Co. Limer-

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.

SFRI

SEE AD ON PAGE 30

SEE AD ON PAGE 26-27

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

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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.

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.

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

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Response Biomedical

Salimetrics

SD Biosensor

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

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.

SEE AD ON PAGE 32

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 research.

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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 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.

Visit us at

Scimedx

MEDLAB

Stand 1B-39

USA • Denville, NJ Tel: (1) 973-625-8822 Web: scimedx.com E-mail: clients@scimedx.com Specializes in immunofluorescence, ELISA, and membrane technologies for a range of autoimmune and infectious diseases.

LabMedica International December/2015-January/2016

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LabMedica 300 Skannex

SM Diagnostics

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.

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.

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.

Siemens Healthcare Diagnostics USA • Tarrytown, NY Tel: (1) 914-631-8000 Web: siemens.com/diagnostics Offers a broad range of products and services used for diagnosing medical conditions, monitoring patient therapy, and providing quality health care.

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SEE AD ON PAGE 3

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: admin@slrresearch.com Provides manufacturers and end users with a wide range of autoimmune components, materials, and services.

automatic and reusable syringes, pipette tips, and accessories.

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Sinnowa

SEE AD ON PAGE 25

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

Spectral Diagnostics 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,

Canada • Toronto, ON Tel: (1) 416-626-3233 Web: spectraldx.com E-mail: info@spectraldx.com Specializes in the development, production and sale of antibody-based tests to guide disease management.

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.

Spinreact Spain • St. Esteve d'en Bas (Girona) Tel: (34) 972-690-800 Web: spinreact.com

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.

SurModics 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.

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SEE AD ON PAGE 32

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.

STRATEC Biomedical

Streck 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. I

Sysmex 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.

Tecan

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.

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).

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.

Teco Diagnostics USA • Anaheim, CA Tel: (1) 714-463-1111 Web: tecodiag.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.

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Telstar Technologies

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

Tokra Medikal 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.

Tokyo Boeki 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.

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

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 discovery support and contract manu-

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.

TriContinent 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.

Veda.Lab 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. SEE AD ON PAGE 35

Trinity Biotech 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.

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 ELISA kits and clinical chemistry reagents for public health.

LabMedica International December/2015-January/2016

Vircell Spain • Granada Tel: (34) 958-44-12-64 Web: vircell.com E-mail: marketing@vircell.com Develops, manufactures and markets ready-to-use kits for the diagnosis of esoteric infectious diseases. SEE AD ON PAGE 34

Vitro

TriLink BioTechnologies 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.

SEE AD ON PAGE 48

Vicotex Switzerland • Pully Tel: (41) 21-728-4286 Web: vicotex.com E-mail: contact@vicotex.com Specializes in the production of

probes for detecting nonrandom chromosomal abnormalities, software applications for pathology and PCR kits for HPV and lymphomas.

Voxtur Bio

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Thermo Fisher Scientific

Treff

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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.

hospital and laboratory equipment, including products for central sterilization.

facturing of therapeutic antibodies.

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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.

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

India • Mumbai Tel: (91) 999-8022240 Web: voxturbio.com E-mail: khushroo@voxturbio.com Manufactures clinical lab diagnostic testing kits, with products focusing on POC testing, immunology, hematology, coagulation, blood bank, containers, and disposables.

VPD Slovenia • Bled Tel: (386) 4-574-50-70 Web: 3in1.si E-mail: export@3in1.si Develops, manufactures, and markets the 2-in-1 and 3-in-1 multiparameter meters designed for monitoring glucose, cholesterol, and triglycerides in the blood.

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. Bioresearch 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

LabMedica 300

Waters

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.

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.

West Medica

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.

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.

Argentina • Rosario Tel: (54) 341-432-9191 Web: wiener-lab.com.ar E-mail: administra@ wiener-lab.com.ar 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 equipment and specialty glass apparatus. Products include containers and vial products from both Type I borosilicate

Webers Germany • Oberhausen Tel: (49) 208-305-505-0 Web: webers.de

Wilmad-LabGlass USA • Vineland, NJ Tel: (1) 856-691-3200 Web: wilmad-labglass.com

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

YOUR GLOBAL SOURCE FOR STERILIZATION ACCESSORIES

E-mail: cs@wilmad-labglass.com Manufactures glass tubing and components, as well as consumables and accessories, for a range of clinical chemistry and biotech applications.

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.

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

Worthington Biochemical USA • Lakewood, NJ Tel: (1) 732-942-1660 Web: worthingtonbiochem.com E-mail: custservice@worthington-biochem.com Manufactures and markets purified enzymes, proteins, and nucleic acids among other

THERMO RESISTANT GLOVES Up to 37 cm in length

products for life science applications in cell biology, tissue dissociation, and molecular biology.

Specializes in developing, manufacturing, and distributing in vitro diagnostic instruments and reagents.

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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.

Yashraj Biotechnology

SEE AD ON PAGE 45

Zer Hitech

India • Mumbai, Maharashtra Tel: (91) 22-2768-1949 Web: yashraj.com E-mail: marketing@yashrajbio.com Manufactures antigens for use in manufacturing of controls and/or calibrators or as primary antigen for immunization for raising antibodies. Also manufactures antibodies for immunoassay systems for laboratory-based research and development.

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

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.

STERILIZABLE INSTRUMENT & WORK-SURFACE MATS TURBO WASHING Thermo-Resistant (-60 °C to 300 °C) MACHINES TRAYS Fully Washable & Flexible Suitable for central sterilization services Sterilizable Heavy Silicone Cover & Transport Tablet SILICON INSTRUMENT MAT

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VICOTEX

S.A.

Place de la Gare 1 • 1009 Pully • Switzerland Tel: (41) 21-728-4286 • Fax: (41) 21-729-6741 E-Mail: contact@vicotex.com

MEDLAB

www.vicolab.com

Stand Z7E31

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Companies by Country ARGENTINA AADEE JS Medicina Electronica Wiener Laboratorios

AUSTRIA Dialab Greiner Bio-One International West Medica

BELGIUM Coris BioConcept D-tek DIAsource ImmunoAssays

BRAZIL Labtest Wama Diagnostica

CANADA Affinity Biologicals DNA Genotek MDS Nordion Response Biomedical Spectral Diagnostics

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