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JANUARY Cellular Mechanism Identified For Severe Viral Hepatitis cientists at the Korea Advanced Institute of Science and Technology (Daejeon, Republic of Korea; www.kaist.ac.kr) concluded that regulatory T cells (Tregs) from patients with AHA have altered functions, compared with Treg cells from healthy individuals. Treg cells from patients with AHA produce higher levels of tumor necrosis factor (TNF), gain features of T-helper 17 cells, and have reduced suppressive activity. The presence of these cells is associated with severe liver injury in patients with AHA. Eui-Cheol Shin, MD, PhD, a professor and senior author of the study, said, “This is the first study on regulatory T cells that contributes to hepatocyte damage in viral hepatitis. It is significant for identifying the cells and the molecules that can be used as effective treatment targets for viral hepatitis in the future.” The study was originally published online on December 8, 2017, in the journal Gastroenterology.

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improved operating efficiency and the flexibility to adapt to changing testing demands. Uwe Oberlaender, PhD, Head of Roche Molecular Diagnostics, said, “By coupling cobas TV/MG with recently launched cobas CT/NG for the detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG), laboratories now have the most flexible, high throughput testing solution on the market today. Laboratories can now simultaneously process, from a single patient sample, any combination of CT, NG, TV and MG, which provides clinicians the valuable information they need to properly diagnosis STIs and improve patient care.”

Immune Response Tests Enable Rapid Antibiotic Decisions he HostDx Sepsis test, developed by Inflammatix (Burlingame, CA, USA; https://inflammatix.com) uses quantitative multiplex gene expression to analyze a patient’s immune system, or the host response, rather than looking for the presence of a pathogen that indicates

Liquid Biopsy Test Detects Eight Types of Common Cancers ancer researchers have developed a “liquid biopsy” blood test that can detect eight common cancer types through assessment of the levels of circulating proteins and mutations in cell-free DNA. The “CancerSeek” test screens for mutations in 16 genes that regularly arise in cancer cells and eight proteins that are often released. The assay was designed to detect the eight common cancer types that account for more than 60% of cancer deaths in the United States. Five of the cancers detected by CancerSeek currently have no screening test. Contributing author Dr. Bert Vogelstein, professor of oncology at Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) said, “this test represents the next step in changing the focus of cancer research from late-stage disease to early disease, which I believe will be critical to reducing cancer deaths in the long term.” The CancerSeek test was described in the January 18, 2018, online edition of the journal Science.

New Test Allows Simultaneous Processing Of Four STDs new test allows simultaneous processing of any combination of four separate sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG), from one patient sample. The new test cobas TV/MG (Roche, Pleasanton, CA, USA; www. roche.com) is for use on the fully automated cobas 6800/8800 Systems that offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with

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whether there is an infection in the blood. The multigene sepsis diagnostic panel would be able to tell from a blood sample whether a hospitalized patient has a bacterial, viral, or no infection so that physicians would be able to administer more appropriate treatments earlier. Timothy E. Sweeney, MD, CEO and founder of Inflammatix said, “Our firm has prospectively validated eight sets of genes for different clinical applications. By reading the immune response, you can tell whether a bacterial or viral infection is causing a patient’s symptoms, and fundamentally that’s what a physician needs to know up front.”

so emerged as an unexpected finding. What we have now discovered about the pro-inflammatory complex mediated by IL-23 appears to be a new paradigm in the field.” The study was published in the January 2018 issue of the journal Immunity.

Residual Disease in Leukemia Patients Identified by ddPCR cientists at the University of Bari, (Bari, Italy; www.uniba.it) designed amplicons to span the BCR-ABL1 junction for patients and then barcoded and sequenced them on the MinION, a portable real-time device for DNA and RNA sequencing (Oxford Nanopore Technologies, Oxford Science Park, UK; https://nanoporetech.com). Chia-Lin Wei, PhD, director of genome technologies at the Jackson Laboratory (Farmington, CT, USA; www.jax.org), said, “The study demonstrated a very suitable application for nanopore sequencing. Although the MinION does not yet have the accuracy to evaluate somatic point mutations in a diagnostic setting, sequencing through translocations is a very ideal type of data for the system. The MinIon’s long reads are particularly valuable since they enable the entire region to be sequenced through in one read, which is important because breakpoint location can vary patient to patient.” The study was published on January 5, 2018, in the journal Oncotarget.

Key Mechanism of Autoimmune and Inflammatory Diseases Revealed cientists at the Flanders Institute for Biotechnology (VIB, Ghent, Belgium; www.vib.be) and their colleagues discovered that the immunomodulatory cytokine IL-23 pro-inflammatory activity, which underlies a wide range of inflammatory diseases, critically depends on structural activation of the cytokine by its receptor, IL-23R. Savvas Savvides, PhD, a professor and senior author of the study, said, “We were surprised to find that both IL-23 and its receptor change drastically to create an intimate cytokine-receptor interface. In this interface, the receptor uses a functional hotspot on IL-23, enabling it to recruit an essential co-receptor for pro-inflammatory signaling. The binding site of the co-receptor on IL-23 al-

Device Leads to Lower Blood Culture Contamination Rates he use of a mechanical initial specimen diversion device and staff education has led to a nearly four-fold decrease in contaminated blood cultures that was sustained over 20 months. Scientists at the Medical University of South Carolina (MUSC, Charleston, SC, USA; www.musc.edu) used the mechanical initial specimen diversion device (ISDD) called SteriPath (Magnolia Medical Technologies, Seattle, WA, USA; https://magnolia-medical. com), which is a sterile, closed blood culture collection system that diverts, sequesters, and isolates the first 1.5-2 mL of blood, the portion that is known to contain contaminants, during the blood draw. Danielle Scheurer, MD, the MUSC Health chief quality officer, said, “By lessening the chances of contaminating a specimen, we increase our accurate diagnoses and treat patients with real infections. This in turn leads to decreased antibiotic use and allows us to help mitigate the ongoing, nationwide problem of antibiotic resistance from over or improper use.” The study was presented at the Institute of Healthcare Improvement National Forum was held December 11, 2017, in Orlando, FL, USA.

FEBRUARY Novel Assay Rapidly Detects Candidemia lood cultures fail to detect yeast in approximately 50% of Candida infections, and typically take two to three days for positive results to be apparent. A commercial blood test seems to perform as well as, if not better than, traditional blood cultures at detecting a type of fungal yeast infection that

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Year’s Top 100 Clinical Developments commonly strikes hospital patients. Scientists at the University of Pittsburgh Medical Center (Pittsburgh, PA, USA; www.health.pitt.edu) concluded that T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. The study was published on February 9, 2018, in the journal Clinical Infectious Diseases.

Mass Spectrometry Test for Newborn Disorders ext-generation mass spectrometry-based solution has been launched to analyze dried blood spots from newborn babies to test for wide range of metabolic disorders. This new in-vitro diagnostic (IVD) kit is intended for the semi-quantitative measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations. The kit analyzes newborn heel prick blood samples dried on filter paper and is used with a tandem mass spectrometer. The NeoBase2 non-derivatized MSMS kit (PerkinElmer, Inc, Waltham, MA, USA; www.perkinelmer.com) can test for up to 57 analytes, including markers for screening of Xlinked adrenoleukodystrophy (X-ALD), the most common peroxisomal disorder. It can also screen for adenosine deaminase severe combined immunodeficiency (ADA-SCID), which is caused by a deficiency of the enzyme ADA and is the second most common SCID.

edu) demonstrated the ability of the Tick-Borne Disease Serochip (TBD-Serochip) assay to detect and differentiate Anaplasma phagocytophilum, Babesia microti, Borrelia burgdorferi, Borrelia miyamotoi, Ehrlichia chaffeensis, Rickettsia rickettsii, Heartland virus and Powassan virus. “Diagnosing tick-borne illness is a difficult journey for patients, delaying effecting treatment,” said senior author Dr. W. Ian Lipkin, professor of epidemiology at Columbia University. “The TBD-Serochip promises to make diagnosis far easier, offering a single, accurate test for eight different TBDs. Early detection of infection enables rapid and appropriate treatment.” The TBD-Serochip test was described in detail in the February 16, 2018, online edition of the journal Nature: Scientific Reports.

CTC Blood Test Detects Early Stage Colorectal Cancer cientists from Chang Gung Memorial Hospital (Taoyuan City, Taiwan; www.cgmh.org.tw) tested 2mL of peripheral whole blood were from each subject for Circulating tumor cells (CTCs) analysis through a routine blood draw. The blood samples were then processed through the CMx platform (CellMax Life, Sunnyvale, CA, USA; www. cellmaxlife.com). The results of these assays were then compared in a blinded analysis with the colonoscopy results. Atul Sharan, MBA, MS, co-founder

Brain Trauma Test Reduces CT Scans he availability of a blood test for mild traumatic brain injury (mTBI) will help healthcare professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients. The blood test known as the Brain Trauma Indicator (Banyan Biomarkers, Inc, San Diego, CA, USA; https://banyanbio.com) works by measuring levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which will not. Being able to predict if patients have a low probability of intracranial lesions can help healthcare professionals in their management of patients and the decision to perform a CT scan. Test results can be available within three to four hours.

Blood Test Detects Multiple Tick-Borne Diseases novel blood test for the simultaneous diagnosis of multiple tickborne diseases has been developed and shown to discriminate antibody responses to eight major tick-borne pathogens present in the United States. Investigators at Columbia University (New York, NY, USA; www.columbia.

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and CEO of CellMax Life, said, “To be effective, tests for early cancer detection need to be non-invasive, easy, highly affordable and accurate, and our CTC blood test meets all of these requirements. Recent surveys reveal a preference for blood tests over stool-based screening tests in more than 80% of patients who did not undergo invasive colonoscopy screening. This test can be an option for these individuals and boost compliance.” The study was presented on January 20, 2018, at the ASCO Gastrointestinal Cancers Symposium held in San Francisco, CA, USA.

tom-made one-step master mix that combines Affymetrix’s VeriQuest master mix and the fast DNA polymerase included in Affymetrix’s USB fast quantitative PCR probe master mix. In the future, the authors plan to focus on sample pretreatment for RNA extraction from plasma, urine, and saliva, as the extraction of high-quality RNA plays a crucial role in producing successful qRT-PCR results. The team aims to market the device at a price of USD 2,000, with disposable test chips for USD 0.50.

Molecular Test Adapted for Parkinson’s and DLB

Molecular Test Device Developed for RNA Viral Detection microfluidic, continuous-flow, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) system to detect viral RNA targets has been developed and its creator have been working to reduce manufacturing costs and identify potential partners for commercialization. Scientists at The Fraunhofer USA Center for Molecular Biotechnology (Newark, DE, USA; www.fraunhofer-cmb.org) tested two one-step reverse transcription PCR (qRT-PCR) mastermixes. The team first used the commercial Affymetrix VeriQuest master mix ((Thermo Fisher Scientific, Santa Clara, CA, USA; www.thermofisher.com), which is composed of reverse transcriptase and DNA polymerase. The team also developed a cus-

arkinson’s disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB) (or Lewy body dementia) are called αsynucleinopathies due to the abnormal accumulation of aggregates of a protein called α-synuclein (αSyn) in the brain. A team of scientists led by those at the National Institutes of Health (Hamilton, MT, USA; www.niaid.nih.gov) tested 60 cerebral spinal fluid (CSF) samples, including 12 from people with Parkinson’s disease, 17 from people with dementia with Lewy bodies, and 31 controls, including 16 of whom had Alzheimer’s disease. These results confirm that αSynD seeding activity is present in cerebrospinal fluid. The team also demonstrated that it can be rapidly detected, and quantitated, even in early symptomatic stages of synucleinopathy. The study was published on February 9, 2018, in the journal Acta Neuropathologica Communications.

Enzymatic Assay Developed for Ether Phospholipids in Plasma thanolamine ether phospholipid (ePE) and choline ether phospholipid (ePC) are found in human plasma (serum), but the relative concentration of the ether phospholipids in the phospholipids of human serum are very low as compared to those in tissues such as leukocytes and erythrocytes. Scientists at the Institute of Rheological Functions of Food (Fukuoka, Japan; www.reoken.com) found that the amount of ePE in human plasma measured by the enzymatic method was well correlated to that by liquid chromatography-electrospray ionization-tandem mass spectrometry (LC/ESI-MS) method, but the correlation of ePC between the two methods was slightly less good than that of ePE. The authors concluded that the method is sensitive and high-throughput for assay of plasma ether phospholipids. The method may also be performed by using a colorimetric microplate readers and/or spectrophotometers. Therefore, the enzymatic method may be performed at many ordinary clinical laboratories without use of expensive apparatus. Furthermore, the enzymatic method may be applied to assay of ether phospholipids (ePE and ePC) not only in human plasma but also to assay of ePE and ePC in the other tissues. The study was published in the March 2018 issue of the journal Practical Laboratory Medicine.

Test Links Circulating Tumor DNA and Breast Cancer Survival ancer researchers used a liquid biopsy test for circulating tumor DNA (ctDNA) to profile cancer genomes from blood samples and predict

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Year’s Top 100 Clinical Developments survival outcomes for patients with metastatic triple negative breast cancer. Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR), and Her2/neu. While TNBC represents just 10-15% of all breast cancer diagnoses, the disease is responsible for 35% of all breast cancer-related deaths. “The recognition that a significant fraction of patients harbor greater than 10% tumor DNA in blood suggests that liquid biopsies may enable routine and non-invasive profiling of cancer genomes for patients with metastatic TNBC,” said senior author Dr. Viktor Adalsteinsson, group leader of the blood biopsy team at the Broad Institute (Cambridge, MA, USA; www. broadinstitute.org). The study was published in the February 20, 2018, issue of the Journal of Clinical Oncology.

MARCH Test Reports Antibiotic Resistance in 2 Hours cientists at the Jena University Hospital (Jena, Germany; www. uni-jena.de) and their colleagues have developed a simple and fast Raman spectroscopy-based procedure to identify antimicrobial susceptibilities and determine the MIC within only two hours total analysis, marking a huge time savings compared to established phenotypic methods nowadays used in diagnostics. Ute Neugebauer, PhD, a professor of Physical Chemistry and senior author of the study said, “We combine light-based analytical methods with microfluidic sample processing. With our Lab-on-aChip system, thus a miniaturized lab, we are able to clearly identify bacterial strains and their resistances, in less than three hours.” The study was published in the February 2018 issue of the journal Analytical Chemistry.

realize liquid biopsy diagnostics, which is a less invasive procedure than the current gold standard tumor biopsies. Scientists at the National University of Singapore (Singapore; www.nus.edu.sg) utilized a microfluidic centrifugal technique, where a spinning rotor generates pressure, forcing the patient’s blood sample to flow through microscopic channels of a specially designed microfluidic chip. The centrifugal platform utilizes a gentle and efficient size-based separation without the requirements of syringe pump and other accessories.

Novel Biomarkers Revealed For Future Dementia Risk n international team of scientists collaborating with those at the University of Texas Health Sciences Center (San Antonio, TX, USA; www.uthscsa.edu) found that higher blood concentrations of molecules called branched-chain amino acids (BCAAs) were associated with lower risk of future dementia. All three BCAAs, isoleucine, leucine, and valine, were inversely associated with incident dementia. Another molecule, creatinine, and two very low-density lipoprotein (VLDL)-specific lipoprotein lipid subclasses also were associated with lower risk of dementia. One highdensity lipoprotein (HDL) and one VLDL lipoprotein subclass were associ-

Non-Invasive Urine Test Detects Prostate Cancer clinical study carried out by scientists at Kaplan Medical Center (Rehovot, Israel; www. clalit-global.co.il) included urine samples that were collected and examined by a cytopathologist using the CellDetect unique color marker (Micromedic Technologies, Tel Aviv, Israel; www.m-medic. com). CellDetect is a new-generation cytopathological staining platform for accurate cancer detection. It offers proprietary diagnostic solutions based on unique combination of color and morphology. The CellDetect efficacy was proven for cervical and bladder cancer in multiple clinical studies and it is estimated that the technology can be implemented for use in additional cancer detection indications. Guy Lerner, MBA, CEO of Micromedic, said, “We are confident that our product has the potential to transform prostate cancer diagnostics, offering patients a non-invasive, accurate and reliable test.”

Liquid Biopsy Platform Isolates Circulating Disease Biomarkers new platform has been created with the potential to extract tiny circulating biomarkers of disease from patient blood. This simple, fast and convenient technique could help

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ated with increased dementia risk. Moreover, creatinine, one HDL, and three VLDL lipoprotein subclasses were also associated with dementia risk, but these associations disappeared when adjusted for BMI and cholesterollowering medication. The study was published on March 5, 2018, in the journal Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

CRP Levels May Indicate Schizophrenia Prognosis evels of C-reactive protein (CRP) indicating low-grade inflammation are associated with worsening scores on several psychometric scales and a poorer overall prognosis over a 1-year period in outpatients with stable schizophrenia. Scientists at the University of Oviedo (Oviedo, Spain; www.uniovi.es) studied stable outpatients that had been diagnosed with schizophrenia for fewer than 10 years. Leticia Gonzalez-Blanco MD, the lead author of the study, said, “By multiple regression analyses, only CRP levels of 3 to 10 mg/L were associated with a worse clinical course on the PANSS [Positive and Negative Syndrome Scale]-Positive, -General and -Total scales]. Higher baseline CRP levels may be a biomarker of poor clinical course in the first 10 years of schizophrenia.” The study was presented on March 5, 2018, at the 26th Congress of the European Psychiatric Association held in Nice, France.

New Dipstick Rapidly Detects Cholera in Acute Diarrhea ecognizing cholera cases early, especially in the initial phase of an outbreak and in areas where cholera has not previously circulated, is a high public health priority, and laboratory capacity in such settings is often limited. Globally, 3 to 5 million cases and over 100,000 deaths occur annually due to cholera. An international team of scientists working with the International Centre for Diarrhoeal Disease Research (Dhaka, Bangladesh; www.icddrb.org) collected fresh stools from hospitalized adults and children at the Dhaka Hospital who presented with acute watery diarrhea. The authors concluded that the Cholkit dipstick is simple to use, requires no dedicated laboratory capacity, and has a sensitivity and specificity for V. cholerae O1 of 98% and 97%, respectively. The study was published on March 14, 2018, in the journal Public Library of Science Neglected Tropical Diseases.

Liquid Biopsy Can Rule Out Early-Stage Lung Cancer

large team of medical scientists working with those at the Medical University of South Carolina, Charleston, SC, USA; www.musc. edu) carried out a prospective multicenter observational trial of patients with 8-30 mm lung nodules at 33 sites in the USA and Canada. The liquid biopsy used in the study was the Xpresys Lung 2 (‘XL2’) a second-generation test by Integrated Diagnostic (Seattle, WA, USA; www.indidx.com). Albert Luderer, PhD, president of Integrated Diagnostics, said, “Physicians can often detect whether a patient is at high risk for cancer, but have difficulty determining when a small lung nodule is benign. Patients determined by traditional means to be at low risk are often put into a watchful waiting category to be re-tested over time. The XL2 test might help patients with low-to-moderate risk of cancer to avoid unnecessary invasive procedures.” The study was published on March 1, 2018, in the journal Chest.

APRIL Assay Detects Hepatitis B in Multiple Specimens novel HBV assay offers advantages over currently used methods due to its capability to detect closed circular DNA (cccDNA) in serum, single cells, and preserved tissue samples. This assay can be used to diagnose hepatocellular carcinoma (HCC) at an earlier stage to manage treatment more effectively. Song-Mei Liu, MD, PhD, the lead investigator at the Wuhan University (Wuhan, China; www.whu. edu.cn) said, “The development of HCC is strongly associated with HBV. Recently, several new antiviral strategies targeting cccDNA have been established to improve HBV clearance. It is of great clinical significance to provide an accurate and sensitive approach for cccDNA detection. With this method, more and more patients with chronic HBV will have precision treatment available to prevent or delay HCC occurrence, and HCC in patients could be diagnosed at an earlier stage.” The study was published on April 12, 2018, in The Journal of Molecular Diagnostics.

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Blood Test Predicts Onset of TB in Advance n international consortium of scientists working with those at Stellenbosch University (Stellenbosch, South Africa; www.sun. ac.za) found that a four-transcript signature (RISK4) which is a combination of four genes associated with inflammatory responses, derived from samples in a South African and Gambian training set, predicted progression up to two years before onset of disease in blinded test set samples. Gerhard Walzl, MMed, PhD, a professor and lead study author, said, “The individual components of this signature may not be sufficient to deliver an accurate diagnosis of prediction, but a combination of these markers improves its accuracy. We are hoping that primary health clinics will be able to use such a test and the reagents would then be readily available in that format, similar to the tests that are currently used to diagnose TB.” The study was published on April 6, 2018, in the American Journal of Respiratory and Critical Care Medicine.

Fingerprint Test Detects Heroin and Cocaine Users test protocol based on liquid chromatography-mass spectrometry (LC-MS) analysis accurately detects levels of illegal drugs in a single fingerprint from drug users while eliminating those who had only passive contact with a drug user. In an earlier study, investigators at the

University of Surrey (United Kingdom; www.surrey.ac.uk) described a test that used a fingerprint to detect cocaine use. Now, in a recent study, the group has improved on the earlier test by developing a new fingerprint protocol that detects both cocaine and heroin. Senior author Dr. Melanie Bailey, lecturer in chemistry at the University of Surrey said, “This is, we believe, the first study to explore the significance of testing for drugs from a fingerprint, and therefore, the first effort dedicated to establishing an environmental cutoff.” The study was published in the March 22, 2018, online edition of the journal Clinical Chemistry.

Chip-Based Blood Test Could Make Bone Biopsies Unnecessary low-cost, reliable blood test uses a small plastic chip about the size of a credit card that can deliver the same diagnostic information as a bone biopsy, but using a simple blood draw instead. Steven A. Soper, PhD, the Distinguished Professor of Chemistry and Mechanical Engineering, and the senior author of the study at the University of Kansas (Lawrence, KS, USA; www.ku.edu), said, “The chip we’re using, because it’s made from a plastic, can be injection molded, the same method that is used to produce CDs, DVDs and Blu-ray Discs. What’s really nice is we can produce these chips for a couple of dollars per chip, which makes it really appropriate for testing in a clinical setting.” The new test will be brought to market by BioFluidica (San Diego, CA, USA; www.biofluidica.com). The study was originally published on January 22, 2018, in the journal Integrative Biology.

Cervical Fluid Test for Gynecological Cancers ervical fluid samples gathered during routine Papanicolaou (Pap) tests are the basis of a new test for endometrial and ovarian cancers. The new screening test called PapSEEK detects mutations in DNA that have been identified for specific cancers sooner. Earlier detection of cancer could lead to earlier treatment and potentially better outcomes for patients. An international team of scientists working with those at Johns Hopkins University School of Medicine (Baltimore, MD, USA; www.hopkins medicine.org) found that PapSEEK was nearly 99% specific for cancer, and it detected 81% of endometrial cancers. Of the endometrial cancer patients studied using Tao brush samples, PapSEEK identified cancer 93% of the time. Of the ovarian cancer patients studied, 45% tested positive for cancer with PapSEEK. There were no false-positive results. When the plasma and Pap brush samples were both tested, the sensitivity of the test for ovarian cancer increased to 63%.

Nanopore Method Developed for Genetic Screening new method that simplifies and accelerates nanopore-based shortlength DNA library preparation and sequencing has been applied to test a panel of normal and aneuploid genomic DNA samples. Scientists at the Columbia University Medical Center (New York, NY, USA; www.cumc.columbia.edu) tested

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the new protocol on nine blinded samples. PGS screening was performed using the VeriSeq PGS assay (Illumina, San Diego, CA, USA; www.illumina.com) with excess DNA used to run the MinION-based workflow (Oxford Nanopore Technologies, Oxford Science Park, UK; https:// nanoporetech.com). S. Zev Williams, MD, PhD, an Associate Professor of Obstetrics and Gynecology, and senior author of the study, said, “One limitation of nanopore sequencing has been its accuracy. However, since aneuploidy detection does not rely on calling point mutations, base-level accuracy is not as important. We want to have an accuracy of over 99%, and to test enough samples to be sure that’s what it is will take time. Nonetheless, I think the potential is there.” The study was published in the April 2018 issue of the journal G3: Genes, Genomes, Genetics.

Rapid Test Developed for Hepatitis C Infections nvestigators at the Pasteur Institute (Paris, France; www.pasteur.fr) developed a POC assay for the qualitative detection of HCV RNA on the PCR Genedrive (Manchester, United Kingdom; www. genedriveplc.com) instrument. Results revealed that the Genedrive PoC assay identified all major HCV genotypes, with a limit of detection of 2362 IU/milliliter. Assessing patients chronically infected with HCV and controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed

98.6% sensitivity and 100% specificity to HCV. The Genedrive HCV diagnostic kit has obtained CE certification for distribution in Europe and will be available for sale in the Middle East, Africa, South-East Asia, and India once local regulatory clearance is obtained. The study was published in the April 3, 2018, online edition of the journal Gut.

Vitamin D Blood Test May Speed Pediatric Bipolar Diagnosis blood test may have the potential to speed accurate diagnosis and proper treatment of bipolar disorder in children. It has been reported that children with bipolar disorder had higher blood levels of a protein associated with vitamin D compared to children without mood disorders. A blood test to confirm bipolar disorder could improve care and cut the current 10-year average lag time between onset and diagnosis. Scientists from The Ohio State University (Columbus, OH, USA; www.osu.edu) concluded that vitamin vitamin D-binding protein (DBP) holds promise as a diagnostic biomarker changing in response to all major factors contributing to pathogenesis of bipolar disorder (BD), and may shed light on BD pathophysiologic mechanisms. Barbara L. Gracious, MD, associate professor of clinical psychiatry and nutrition and a lead study coauthor, said, “Childhood bipolar disorder can be very difficult to distinguish from other disorders, especially in youth with certain types of depression. Prompt Visit us at diagnosis and appropriate treatment alleviates the suffering of the child and family, and can potentially lessen the risk for suicide.” The study was published on MEDLAB March 13, 2018, in the journal TranslaStand Z4.C30 tional Psychiatry.

Smartphone Microscopes Transformed into Laboratory Devices t has recently been demonstrated that deep learning, a powerful form of artificial intelligence, can discern and enhance microscopic details in photos taken by smartphones. The technique improves the resolution and color details of smartphone images so much that they approach the quality of images from laboratory-grade microscopes. Bioengineers at the Samueli School of Engineering, University of California (Los Angeles, CA; USA; https:// samueli.ucla.edu) photographed images of lung tissue samples, blood and Papanicolaou smears, first using a standard laboratory-grade microscope, and then with a smartphone with the 3D-printed microscope attachment. The scientists then fed the pairs of corresponding images into a computer system that “learns” how to rapidly enhance the mobile phone images. The process relies on a deep-learning-based computer code, which they had developed. The study was published online on March 15, 2018, in the journal ACS Photonics.

Cancer Blood Test Provides Earlier Detection of Tumors new innovative microfluidic device uses magnetic particles and wavy-herringbone design to capture and release circulating tumor cells (CTC) with a high capture efficien-

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cy rate at different tumor cell concentrations. Scientists at Lehigh University (Bethlehem, PA, USA; www1.lehigh.edu) designed the device to create passive turbulence and increase the possibility of tumor cells colliding with the device wall. Yaling Liu, PhD, an associate professor and the senior author of the study, said, “With metastatic cancers accounting for around 90% of deaths from solid tumors, the hope is that one day a device that can enable the analysis of single tumor cells circulating in the blood could make a big difference in early diagnosis, detection and monitoring of numerous types of cancer, without invasive biopsies.” The study was presented April 18, 2018, at Royal Academy of Science International Trust’s “The Future of Medicine” conference held in Istanbul, Turkey.

the fight against sepsis. The Early Sepsis Indicator uses the DxH 900 hematology analyzer (Beckman Coulter, Brea, CA, USA; www.beckmancoulter. com), which characterizes cells in their near-native states. The system’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes, cells of the innate immune system that provide a first line of defense against infections. Monocytes play a role in the dysregulated immune response to sepsis, and identifying morphological changes provides insight into possible sepsis earlier than other indicators.

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team of scientists from Imperial College London (London, UK; www. imperial.ac.uk) used invisible mid-infrared light to photograph tissue slices in a way that maps out chemical changes that signal the onset of cancer. In particular, they measured the ‘nuclear-to-cytoplasmic-ratio’ (NCR): a recognized biological marker for a wide range of cancers. The team then used the Digistain imager to get a ‘Digistain index’ (DI) value averaged over the corresponding RoI on the other, unstained slice, and ran a statistical analysis on the results. Chris Phillips, PhD, a Professor of Experimental Solid State Physics and lead investigator of the study, said, “Our machine gives a quantitative ‘Digistain index’ (DI) score, corresponding to the NCR, and this study shows that it is an extremely reliable indicator of the degree of progression of the disease. Because it is based on a physical measurement, rather than a human Visit us at judgement, it promises to remove the element of chance in cancer diagnosis.” The study was published on March 13, 2018, in the journal Convergent Science PhysiMEDLAB Stand Z4.D29 cal Oncology.

Cutting-Edge Technology Applied to Grading Cancer Tumors

Early Sepsis Indicator Alerts Emergency Clinicians hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis has received the European CE Mark. The first early sepsis warning solution to be offered as part of a routine complete blood count (CBC) with differential test gives physicians a rapid and simple tool that can aid in

More Accurate Test for Prostate Cancer Risk new blood test for determination of prostate cancer risk was found to be more accurate than the current gold standard PSA (prostate specific antigen) test. The IsoPSA test was developed to evaluate structural changes in the PSA isoforms that correlate with prostate cancer. This approach not only reduces the number of false positives, it also allows providers a window into the cancer grade before deciding on whether a biopsy is indicated. In a recent study, investigators at the Cleveland Clinic (OH, USA; www.clevelandclinic.org) found that more than 40% of biopsies could have been avoided in both the preliminary study (45.1%) and validation study (47%), suggesting that use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of over detection and overtreatment of nonlethal prostate cancer. The validation study was presented May 18, 2018, at the San Francisco, CA, USA, 13th Annual Meeting of the American Urological Association and was published in the April 2018 online edition of the Journal of Urology.

Antigen Matching Advance Could Transform Transfusion Medicine cientists at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) and their colleagues created a

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database of molecular changes in red blood cell (RBC) and platelet antigens, thereby developing an automated antigen-typing algorithm based on wholegenome sequencing (bloodTyper). Connie M. Westhoff, PhD, from the New York Blood Center (New York, NY, USA; https://nybloodcenter.org) and cofirst author of the study said, “This approach has the potential to be one of the first routine clinical uses of genomics for medical care for patients needing blood transfusion. It could prevent serious or even fatal complications because once patients are sensitized they have a life-long risk of hemolytic transfusion reactions if blood transfusion is needed in an emergency.” The study was published on May 17, 2018, in the journal The Lancet Haematology.

Cas13 enzyme paired with reporter molecules to indicate the presence of a genetic target, such as a virus. Until now, a crucial preliminary step for SHERLOCK involved extracting and isolating nucleic acids from patient samples, which typically requires a laboratory and trained personnel, making it difficult to accomplish in the field. The team developed a simpler method that allows Cas13 to detect its target directly in bodily fluid samples such as saliva or blood. The process is called HUDSON, or Heating Unextracted Diagnostic Samples to Obliterate Nucleases.

Breath and Urine Tests Detect Early Breast Cancer cientists at the Ben-Gurion University of the Negev (Beersheba, Israel; www.bgu.ac.il) concluded that the developed statistical analysis method enables accurate classification of patients as healthy or with breast cancer, based on simple non-invasive exhaled breath and a urine sample analysis. This study demonstrates that available commercial electronic noses can be used, provided that the data analysis is carried out using an appropriate method. Yehuda Zeiri, PhD, a professor of Biomedical Engineering and senior author of the study said, “Our new approach utilizing urine and exhaled breath samples, analyzed with inexpensive, commercially available processes, is non-invasive, accessible and may be easily implemented in a variety of settings.” The study was published on May 1, 2018, in the journal Computers in Biology and Medicine.

SHERLOCK Diagnostic Platform Optimized for Rapid Viral Detection cientists at the Broad Institute of the Massachusetts Institute of Technology (MIT, www.broadinstitute.org) and Harvard Medical School (Cambridge, MA, USA; https://hms.harvard.edu) has also streamlined SHERLOCK’s (Specific High-sensitivity Enzymatic Reporter unLOCKing) capabilities to distinguish related viral species from one another and demonstrated the platform’s ability to identify clinically relevant mutations, such as a small mutation in Zika virus that has been associated with microcephaly. The SHERLOCK diagnostic platform uses a programmed

Hereditary Breast Cancer Tests Double Detection Rate s clinical whole-genome sequencing becomes increasingly feasible, it is crucial to understand the implications of expanded genetic testing on practice and patient experiences. Multi-institutional scientists led by Stanford University (Stanford, CA, USA; www.stanford. edu) concluded that multiple-gene sequencing rapidly replaced BRCA1/2-only testing for patients with breast cancer in the community and enabled two-fold higher detection of clinically relevant pathogenic variants without an associated increase in prophylactic mastectomy. However, important targets for improvement in the clinical utility of multiple-gene sequencing include postsurgical delay and racial/ethnic disparity in variants of uncertain significance. The study was published on May 10, 2018, in the journal JAMA Oncology.

Serum Biomarkers Improve Preeclampsia Screening screening method for predicting preeclampsia based on the mother’s risk factors and biomarker measurements outperforms a standard method based only on maternal characteristics and medical history. Scientists at King’s College Hospital (London, UK; www. kch.nhs.uk) and their colleagues carried out a prospective multicenter study screening program for preeclampsia (SPREE) in seven National Health Service maternity hospitals in England concluded that the performance of screening is substantially improved by a method combining maternal factors with biomarkers. Liona Poon, MD, a clinical senior lecturer and co-author of the study, said, “The SPREE study has provided definitive proof to support risk-based screening for

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preterm-preeclampsia using various biomarkers. It is now time to revise the professional guidelines and to move away from using a checklist-based method for screening.” The study was published originally published online on March 14, 2018, in the journal Ultrasound in Obstetrics Gynecology.

New Test Predicts Risk of Preterm Birth ollaborating scientists from different institutions working with the University of California - San Francisco (San Francisco, CA, USA; www.ucsf.edu) built a comprehensive test that would capture both spontaneous preterm births, which occurs when the amniotic sac breaks or contractions begin spontaneously, and “indicated” preterm birth, in which a physician induces labor or performs a cesarean section because the health of the mother or baby is in jeopardy. The scientists also wanted to be able to identify risk for preeclampsia, which is not included in current tests for preterm birth. Laura Jelliffe-Pawlowski, PhD, an associate professor of epidemiology and first author of the study, said, “There are multifactorial causes of preterm birth, and that’s why we felt like we needed to build a model that took into account multiple biological pathways. The model works especially well for early preterm births and preeclampsia, which suggests that we’re effectively capturing severe types of preterm birth.” The study was published on May 24, 2018, in the Journal of Perinatology.

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Chip Developed to Detect Cancer in 30 Minutes cientists at the National Chung Cheng University (Chiayi, Taiwan; www.ccu.edu.tw) have developed a low-cost, compact biochip for protein detection. Nanofractures formed by self-assembled gold nanoparticles at junction gaps are applied for ion enrichment and depletion to create a trapping zone when electroosmotic flow occurs in microchannels. Chun-Ping Jen, PhD, the leading study author, said, “People with cancer have some specific proteins in their bodies, which are called tumor markers. However, the proteins cannot usually be detected until they are in a large concentration during the middle and later stages of cancer. The chip, which took five years to develop, will be fitted into a handheld medical device than can also be used in the detection of other diseases. The study was originally published in the September 2018 issue of the journal Biomicrofluidics.

JUNE Portable Device for Early-Stage Malaria Detection

ioengineers at the University of Southern California (Los Angeles, CA, USA; www.usc.edu) have developed a portable, magneto-optic technology for early-stage malaria diagnosis, based on the detection of the malaria pigment, hemozoin. The portable optical diagnostics system (PODS) prototype detects a byproduct generated by all species of the malaria parasite, and as such offers a rapid screening for all malaria strains. Because the amount of hemozoin in the blood is directly related to how far the malaria infection has progressed, it is an ideal indicator of infection. Andrea Martin Armani, PhD, a professor of Chemical Engineering and Materials Science, and senior author of the study, said, “Malaria primarily impacts low-resource environments where supply chain management is difficult and access to power can be unreliable. Therefore, an effective malaria diagnostic must be independent of these.” The study was published on May 21, 2018, in the journal ACS Sensors.

Urinary Markers Predict Bone Problems After Hip Replacement eri implant osteolysis is commonly diagnosed after substantial bone loss has occurred, making revision surgery more challenging. A method has been developed to identify urinary biomarkers that differentiate total hip replacement patients who eventually develop osteolysis from patients who do not. Scientists at Rush University Medical Center (Chicago, IL, USA; www.rush.edu) concluded that their results demonstrate the potential of using non invasive biomarkers to identify patients at risk for peri implant osteolysis long before the emergence of radiographic signs. Further, the high accuracy of the pre-operative biomarker levels demonstrates the potential importance of pre-existing, patient-specific factors driving subsequent osteolysis. The study was published on June 5, 2018, in the Journal of Orthopaedic Research.

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New Method Can Quickly and Accurately Detect Infections method has been developed that can show quickly and accurately whether a person has been infected with harmful bacteria or other pathogens as well as the exact severity of infection in a person. Biochemists at the University of Texas at San Antonio (TX, USA; www. utsa.edu) sought out an easier and more rapid method of testing for infection, resolved to test an electrochemical approach. They created molecules that bind to leukocyte enzymes and produce an electrical current to signal the presence of an infection. Their new molecules are housed on a testing strip. After being contacted with infected bodily fluids, the strip is connected to a computer monitor that displays a clear range of electrochemical responses demonstrating the severity of an infection. Stanton F McHardy, PhD, a professor of Medicinal Chemistry, said, “The signs and symptoms people demonstrate aren’t always reflective of the level of their infection. This device could very easily show just how serious an infection is and make diagnosis a much quicker process, possibly preventing a more serious illness.” The study was originally published online n April 20, 2018, in the journal ChemBioChem.

Treponemal Subspecies Discriminated by LAMP team of scientists working with the Institute for Primate Research (Göttingen, Germany; www.leibniz-gemeinschaft.de) used loopmediated isothermal amplification (LAMP) assays to rapidly differentiate infection with any of the three Treponema pallidum subspecies (pallidum (TPA), pertenue (TPE), and endemicum (TEN)) and which are known to infect humans and nonhuman primates (NHPs). Four TPA, six human, and two NHP TPE strains, as well as two human TEN strains were used to establish and validate the LAMP assays. The authors concluded that the newly designed LAMP assays provide proof of concept for a diagnostic tool that enhances yaws clinical diagnosis. It is highly specific for the target DNA and does not require expensive laboratory equipment. Test results can potentially be interpreted with the naked eye, which makes it suitable for the use in remote clinical settings. The study was published on April 12, 2018, in the journal Public Library of Science Neglected Tropical Diseases.

New Protein Analysis Tool Improves Diagnostic Accuracy cientists at the University at Buffalo (Buffalo, NY, USA; www. buffalo.edu) and their colleagues developed a new protein analysis tool that could vastly increase the speed and precision with which disease and drug effects are analyzed. The groundbreaking tool, called IonStar, is the first to provide near-perfect accuracy when quantifying and comparing the abundance of proteins in the bodies of people who are healthy and ill. Jun Qu, PhD, a professor in the UB School of Pharmacy and Pharmaceutical Sciences and lead investigator, said, “IonStar will totally change the face of clinical and pharmaceutical studies and industry, where large investigations are often critical. If you can analyze a large number of patients with high-quality data, you can discover and track biomarkers much more accurately and reliably.” The study was published on May 9, 2018, in the journal Proceedings of the National Academy of Sciences.

Blood Test Predicts Death Risk From Coronary Disease ncreased circulating ACE2 predicts adverse outcomes in patients with heart failure (HF), but it is unknown if elevated plasma ACE2 activity predicts major adverse cardiovascular events (MACE) in patients with obstructive coronary artery disease (CAD). Scientists at the University of Melbourne (Parkville, Australia; www.unimelb.edu.au) concluded that elevated plasma ACE2 activity is an independent predictor of MACE in patients with obstructive CAD. Louise M. Burrell, a professor of Cardiology and senior author of the study, said, “We have come a long way in treating coronary artery disease but certain patients continue to be at high risk of dying. This new blood test helped identify such patients who may derive benefit from more aggressive treatment.” The study was published on June 13, 2018, in the journal Public Library of Science ONE.

JULY Accurate Test for Chronic Fatigue Syndrome cientists at Columbia University Mailman School of Public Health (New York, NY, USA; www.mailman.columbia.edu) confirmed reports of altered plasma levels of choline, carnitine and complex lipid metabolites and demonstrated that patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and IBS have increased plasma levels of ceramide. Integration of fecal metagenomic and plasma metabolomic data resulted in a stronger predictive model of ME/CFS than either metagenomic (cross-validated AUC = 0.745) or metabolomic analysis alone. Among the top plasma biomarkers differentiating ME/CFS patients from controls were decreased levels of betaine, complex lipids such as lysophosphatidylcholine (LPC), phosphatidylcholine (PC) and sphingomyelin (SM), and increased levels of triglycerides (TG), α-Nphenylacetyl-glutamine, ε-caprolactam and urobilin. The authors concluded that identification of ME/CFS subgroups characterized by specific metabolomic profiles that integrate primary metabolites, biogenic amines, complex lipidomics and oxylipins may enable delineation of subtypes and lead to specific diagnostic and therapeutic strategies. The study was published on July 3, 2018, in the journal Scientific Reports.

Biomarker Discovered for Hypervirulent Pathogen n international team of scientists led by those at the University at Buffalo (Buffalo, NY, USA; www.buffalo.edu) found that the genes peg-344, iroB, iucA, prmpA, and prmpA2 all demonstrated >0.95 diagnostic accuracy for identifying strains in the hvKp-rich cohort. Quantitative siderophore production of ≥ 30 μg/mL also strongly predicted strains as members of the hvKp-rich cohort (accuracy 0.96) and exhibited a hazard ratio of 31.7 for severe illness or death. The string test, a widely used marker for hvKp strains, performed less well, achieving an accuracy of only 0.90. Thomas A. Russo, MD, a professor of medicine and senior author of the study said, “The advantage of identifying these genetic biomarkers is that they can be developed into rapid nucleic acid tests, and if approved by the US Food and Drug Administration, would then provide clinicians with an accurate method to quickly determine if a patient is suffering from an infection due to the classical or hypervirulent strain.” The study was published on June 20, 2018, in the Journal of Clinical Microbiology.

Microfluid Application to Enable Noninvasive Prenatal Testing ioengineers at the University of South Australia (Adelaide, Australia; www.unisa.edu.au) demonstrated for the first time the utility of inertial microfluidics for efficient isolation of trophoblastic cells from maternal peripheral blood. Marnie Winter, PhD, a bioengineer and first author of the study, said, “From about five weeks into the pregnancy, fetal cells originating from the placenta can be found in a mother’s bloodstream. Using modern microfluidic technology, we can now isolate these extremely rare cells (about one in a million) from the mother’s white blood cells and collect them for genetic analysis. We are hopeful that this device could result in a new, non-invasive prenatal diagnostic test able to detect a wide range of genetic abnormalities in early pregnancy from a simple blood sample.” The study was first published on June 14, 2018, in the journal Advanced Materials Technologies.

Saliva Test Offers Improved Respiratory Virus Diagnosis cientists from the University of Hong Kong (Pokfulam, Hong Kong; www.hku.hk) carried out a prospective diagnostic validity study comparing the detection rate of respiratory viruses between saliva and nasopharyngeal aspirate (NPA) among adult hospitalized patients using Xpert Xpress Flu/RSV (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). The authors concluded that saliva specimen had high sensitivity and specificity in the detection of respiratory viruses by an automated multiplex Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care molecular

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assay when compared with that of NPA. The use of saliva also reduces the time and cost associated with specimen collection. The study was published on June 12, 2018, in the journal Clinical Microbiology and Infection.

driven the development of the new Thermo ScientificTM CascadionTM SM Clinical Analyzer (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com).

Genetic Connections Uncovered Between Psychiatric Disorders

Molecular Test Device Developed For RNA Viral Detection

large team of scientists led by those at Massachusetts General Hospital (Boston, MA, USA; www.massgeneral.org) found that common variant risk for psychiatric disorders was shown to correlate significantly, especially among attention deficit hyperactivity disorder (ADHD), bipolar disorder, major depressive disorder (MDD), and schizophrenia. By contrast, neurological disorders appear more distinct from one another and from the psychiatric disorders, except for migraine, which was significantly correlated to ADHD, MDD, and Tourette syndrome. In the general population, the personality trait neuroticism is significantly correlated with almost every psychiatric disorder and migraine. Schizophrenia correlated with many psychiatric disorders, whereas the immunopathological affliction Crohn’s disease did not, and posttraumatic stress syndrome was also largely independent of underlying traits. Essentially, the earlier the onset of a disorder, the more inheritable it appeared to be. The study was published on June 22, 2018, in the journal Science.

microfluidic, continuous-flow, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) system to detect viral RNA targets has been developed and its creators have been working to reduce manufacturing costs and identify potential partners for commercialization. Scientists at The Fraunhofer USA Center for Molecular Biotechnology (Newark, DE, USA; www.fraunhofer-cmb.org) developed the microfluidic chip that contains a syringe pump, heaters, and an optical detection system. The team used the syringe pump to introduce the liquid sample and PCR reagents into the system through a microfluidic connector. The purified RNA solution enters a mixing chamber and is then combined with the master mix, which contains the enzymes and other reagents required to conduct amplification. The mixture travels through a reverse transcription zone, where reverse transcription enzymes convert RNA to complementary DNA. The team demonstrated that that the system performs qRT-PCR in 30 minutes, compared to 80 minutes for standard conventional benchtop thermocyclers. Using the commercial mix and the Ebola virus RNA as the target, the team achieved a limit of detection of 10 RNA copies per microliter.

Homogeneous BTK Occupancy Assay Developed cientists from Gilead Sciences, Inc, (Foster City, CA, USA; www.gilead.com) developed a novel duplex homogeneous Bruton’s tyrosine kinase (BTK) occupancy assay based on time-resolved fluorescence resonance energy transfer (TR-FRET) to measure free and total BTK levels in a multiplexed format. The assay can measure target engagement in peripheral blood mononuclear cells (PBMCs) and in lymph node and bone marrow samples. The assay provides accurate, quantitative assessment of BTK occupancy and currently is in use in ongoing tirabrutinib clinical studies. Utility of the assay also was demonstrated using cells derived from lymph node and bone marrow samples from patients with chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL). The study was published on July 6, 2018, in the journal SLAS Discovery: Advancing Life Sciences R&D.

LAMP Accurately Screens for Malaria in Pregnancy regnant women are especially susceptible to Plasmodium infections and have the risk of developing severe disease and birth complications. These might include maternal anemia, intra-uterine growth retardation, infant low birth weight, prematurity, miscarriage and stillbirth. Scientists at the Universidad de Antioquia (Medellín, Colombia; www.udea.edu.co) analyzed blood samples for Plasmodium parasites by light microscopy (LM), rapid diagnostic test (RDT) and loop mediated isothermal amplification (LAMP). The researchers concluded that LAMP is a simple, rapid and accurate molecular tool for detecting gestational and placental malaria, being able to overcome the limited sensitivity of LM and RDT. These findings could guide maternal health programs in low-transmission settings to integrate LAMP in their surveillance systems for the active detection of low-density infections and asymptomatic malaria cases. The study was published on July 13, 2018, in the Malaria Journal.

AUGUST Automated Clinical LC-MS/MS Driving Faster, More Reliable Results y eliminating and/or automating many of the error-prone manual steps involved in traditional workflows, a fully automated LCMS/MS system could simplify and accelerate the collection of high quality, reliable data that’s right the first time. Consequently, such an advanced system would significantly reduce the need to perform repeat runs, driving faster decisions and giving clinical scientists added confidence in the validity of their results. Moreover, as this system could be operated by nonLC-MS/MS experts, more experienced scientists would have more time to pursue other laboratory tasks. This clear need for a fully automated LCMS/MS system that is designed specifically for the clinical laboratory has

Breath Test Detects Early-Stage Parkinson’s Disease cientists at the Technion Israel Institute of Technology (Haifa, Israel; www.technion.ac.il) described for the first time a clinical trial to distinguish between de novo PD and control subjects using an electronic system for the detection of volatile molecules in exhaled breath (sensor array). They further determined for the first time the association to other common tests for PD diagnostics as smell, ultrasound, and nonmotor symptoms. The breath-testing device contains an array of 40 sensors made of carbon nanotubes or gold nanoparticles. Each sensor had a different chemical attached that could bind certain volatile molecules in the breath, and this binding changed the electrical resistance of the sensor. The authors reported that the test was able to detect early-stage Parkinson’s patients before medication and showed sensitivity, specificity, and accuracy values of the sensor array to detect PD from controls were 79%, 84%, and 81% respectively, in comparison with midbrain ultrasonography (93%, 90%, 92%) and smell detection (62%, 89%, 73%). The study was published online on July 10, 2018, in the journal ACS Chemical Neuroscience.

Immunochromatographic Test Rapidly Diagnoses Parasitic Infection he serological diagnosis of human infection with Angiostrongylus cantonensis remains problematic because there are no commercially available validated tests. Most laboratories use domestically prepared tests such as the enzyme-linked immunosorbent assay (ELISA) or immunoblotting. Scientists working with those at the Mahidol University (Bangkok, Thailand; www.mahidol.ac.th) assessed the rapid lateral flow immunochromatographic assay designated AcQuickDx Test to detect anti-A. cantonensis antibodies in human sera. The authors concluded that the AcQuickDx test is rapid, highly sensitive and specific, and easy to perform without additional equipment or ancillary supplies. It yields results that are interpreted visually, and possesses a long shelf life at room temperature. Thus, it can be applied as an additional test for clinical diagnostic support of angiostrongyliasis either in conventional laboratories or for remote areas where laboratory infrastructure is not available. The study was published in the August 2018 issue of the International Journal of Infectious Diseases.

Biomarker-Based Blood Test Developed for Early Cancer Diagnosis A blood test for early detection of kidney cancer is based on the KIM-1 (Kidney-injury-molecule-1) protein biomarker. Renal cell carcinoma (RCC) has the potential for cure with surgery when diagnosed at an early stage. To this end, KIM-1 has been shown to be elevat-

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Annual Review 2018 ed in the plasma of RCC patents. Investigators at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) examined whether plasma KIM-1 could represent a means of detecting RCC prior to clinical diagnosis. “Early detection of kidney cancer can be lifesaving. We can cure kidney cancer when we detect it at an early stage, but patients with advanced kidney cancer have a very high death rate,” said contributing author Dr. Venkata Sabbisetti, a researcher in the renal division of Brigham and Women’s Hospital. “However, kidney cancer is asymptomatic and many patients present with advanced kidney cancer at the time of diagnosis. Our results suggest that with further refinement, KIM-1 has the potential to identify patients with early, curable kidney cancer.” The KIM-1 study was published in the July 23, 2018, online edition of the journal Clinical Cancer Research.

Blood-Based Test Predicts Benefits Of Lung Cancer Treatment lthough programmed death-ligand 1–programmed death 1 (PDL1–PD-1) inhibitors are broadly efficacious, improved outcomes have been observed in patients with high PD-L1 expression or high tumor mutational burden (TMB). A large team of scientists led by those at UC Davis Comprehensive Cancer Center (Sacramento, CA, USA; www. ucdmc.ucdavis.edu) have developed a novel, technically robust, bloodbased assay to measure TMB in plasma (bTMB, Foundation Medicine, Cambridge, MA, USA; www.foundationmedicine.com). David R. Gandara, MD, a professor and the lead author of the study, said, “These are exciting times in lung cancer immunotherapy. Having a blood test that can identify those patients most likely to benefit would be a huge advantage for both physicians and patients. This publication is the first step toward what I anticipate will be full clinical application of this assay.” The study was published on August 6, 2018, in the journal Nature Medicine.

Lateral-Flow Assay Rapidly Detects Plague Bacteria lague caused by Yersinia pestis is a known flea-borne disease that can trigger large epizootics among the rodent population. Humans that live in environments close to these rodents can contract the bubonic plague either through direct contact with infected animals or through transmission by infective flea bites. Scientists at the National Defense Medical Center (Taipei, Taiwan; www.ndmctsgh.edu.tw) developed a rapid, cheap, sensitive, and specific technique, the lateral flow assay (LFA F1 strips), to detect this pathogen, by using paired monoclonal antibodies (MAbs) against Y. pestis capsule like fraction 1 (F1) protein. The authors concluded that the MAb-format-LFA will be valuable as a diagnostic tool for the detection of Y. pestis. This report shows that the F1 strip is sufficient to support not only the detection of plague in simulated clinical samples, but also it may be a good candidate to meet the epidemiological surveillance during an outbreak of the biological warfare. The study was published on August 14, 2018, in the journal BMC Infectious Diseases.

New Test Predicts Potential Success of BCG Immunotherapy for Bladder Cancer laboratory test that measures the amount of IL2 secretion from CD4+ T cells after overnight in vitro incubation with tuberculin predicts the potential success of BCG (Bacille Calmette-Guérin) immunotherapy treatment for bladder cancer. Investigators at Brighton and Sussex Medical School (United Kingdom; www.bsms.ac.uk) examined the in vitro tuberculin-responsiveness of CD4+ T cells before BCG immunotherapy in patients with high-risk (non-muscle invasive bladder cancer) NMIBC. Senior author Dr. Florian Kern, professor of immunology at Brighton and Sussex Medical School, said, “The simplicity of our new test makes it very attractive as a clinical test. There are several tests for tuberculosis that are ultimately based on the same test principle and have been rolled out across the world in recent times.” The study was published in the August 17, 2018, online edition of the journal Cancer Immunology Research.

Year’s Top 100 Clinical Developments Blood Test Predicts Lymphoma Therapy Success large team of scientists led by Stanford Medicine (Stanford, CA, USA; http://med.stanford.edu) tracked circulating tumor DNA (ctDNA) levels in patients with diffuse large B cell lymphoma that were treated at six medical centers, three in the USA and three in Europe. For each patient, they compared levels of ctDNA before treatment began with the levels after the first and second rounds of conventional chemotherapy. They then correlated those changes with each patient’s outcome. David M. Kurtz, MD, PhD, the lead author of the study, said, “We found that ctDNA levels serve as a very sensitive and specific biomarker of response to therapy within as few as 21 days. Every year, about 30,000 people in the USA are diagnosed with diffuse large B cell lymphoma and, for the most part, they’re treated with six cycles of combination therapy. But we know that not all patients need six cycles. A large fraction could be cured with fewer cycles, maybe even just two. If we can identify those people who are responding extremely well, we could spare them additional treatments. Conversely, we could intensify the therapy or seek other options for those who are not responding as well as we would have hoped.” The study was published on August 20, 2018, in the Journal of Clinical Oncology.

SEPTEMBER New Biomarker Panel Could Accelerate Autism Diagnosis o biomarker tests for autism spectrum disorder (ASD) currently exist. Children are diagnosed based on their altered behaviors, which may not become evident until children are two to four years old. Families often must wait over a year or more for an appointment with a specialist, delaying diagnosis even further. A team of scientists working with those at the University of California Davis (Davis, CA, USA; www. ucdmc.ucdavis.edu) compared blood metabolites, specifically, amino acids, in children with ASD against children showing typical development. They found that 17% of the ASD children had unique concentrations of specific amino acids, known as metabotypes, in their blood. David G. Amaral, PhD, a professor of psychiatry and lead investigator of the study, said, “With this panel of alterations in amino acid metabolism, we can detect about 17% of kids with ASD. This is the first of hopefully many panels that will identify other subsets of kids with autism.” The study was published on September 6, 2018, in the journal Biological Psychiatry.

New Test Procedure Diagnoses Multi-Resistant Pathogens edical microbiologists at the University Hospital of Cologne (Cologne, Germany; www.uni-koeln.de) developed a new method for the rapid detection of carbapenemases directly from positive blood culture (BC) using a new multiplex immunochromatographic test (ICT). Axel Hamprecht, MD, a professor and lead author of the study said, “With this procedure, we have come a giant step closer to our goal of being able to help patients infected with multi-resistant pathogens as quickly as possible. In the case of the aggressive pathogens we are confronted with, every minute counts in order to start a targeted therapy.” The study was published on September 14, 2018, in the journal PLOS ONE.

DNA Test Predicts Risk of Leukemia Relapse cute myeloid leukemia (AML) is the most common type of leukemia in adults, comprising about one quarter of all cases. A group of Canadian and Korean scientists working with the University of Toronto (Toronto, ON, Canada; https://medicine.utoronto.ca) developed new computational tools to parse the leukemia-driving mutations from the sea of sequence data. This allowed them to identify low residual mutation frequency of 0.2% to use as a surrogate marker for giving a personal chance of relapse. Dennis Dong Hwan Kim, MD, PhD, an associate professor and co-lead author of the study, said, “In AML, it is very important to predict who is going to relapse. If we are able to identify someone who is at high risk of relapse then we can do therapeutic intervention earlier which can improve their outcome in the long run.” The study was published on August 14, 2018, in the journal Blood.

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Annual Review 2018 Blood Test May Help Detect Kidney Cancer Earlier enal cell carcinoma (RCC) has the potential for cure with surgery when diagnosed at an early stage. Kidney injury molecule-1 (KIM1) has been shown to be elevated in the plasma of RCC patients. Scientists from the Beth Israel Deaconess Medical Center (Boston, MA, USA; www.bidmc.org) found that patients who eventually developed renal cell carcinoma had double the concentration of kidney injury molecule-1 in prediagnostic plasma. The authors concluded that plasma KIM-1 concentrations could predict RCC incidence up to five years prior to diagnosis and were associated with poorer survival. Rupal Bhatt, MD, PhD, a medical oncologist and the senior author of the study, said, “Renal cell carcinoma has the potential for cure with surgery when diagnosed at an early stage. Kidney injury molecule-1 has been shown to be elevated in the plasma of renal cell carcinoma patients.” The study was published on September 6, 2018, in the journal Clinical Cancer Research.

Liquid Biopsy Identifies Chronic Liver Diseases recently developed liquid biopsy cell-sorting device was able to detect circulating epithelial cells of hepatocyte origin in blood from healthy individuals, patients with chronic liver disease without hepatocellular cancer (HCC), and those with HCC. A cell-sorting device had previously been developed to isolate epithelial cells in the circulation (circulating epithelial cells, or CECs) from patient blood samples and combined it with a messenger RNA (mRNA) analysis system to identify CECs with liver-specific markers. Scientists from Massachusetts General Hospital (Charlestown, MA, USA; www.massgeneral.org) that the novel detection of cells from diseased livers circulating in the bloodstream both by immunofluorescence and RNA-sequencing have the potential to use these cells as biomarkers. Important applications of this liquid biopsy may include CLD etiology determination, fibrosis staging, and HCC surveillance. Further study of CECs could open a new field of biomarker development leading to a spectrum of non-invasive diagnosis and monitoring techniques for patients with liver disease. The study was published on September 12, 2018, in the journal Gastroenterology.

Test Diagnoses for Uterine Infections Impacting Fertility pproximately 10% of women in the general population may have chronic endometritis, but among infertile women undergoing IVF, the rate is 15%, with rates estimated as high as 60% among women experiencing recurring implantation failure or miscarriage. Igenomix (Valencia, Spain; www.igenomix.com), a reproductive genetics firm, has developed the first commercial assay for diagnosing chronic endometritis, a symptomless infection in the uterine lining that can impact a woman’s fertility. The firm is commercializing the test, along with other genetic analyses of endometrial status, in the EU and plans to bring it to its USA laboratories upon CLIA approval. The assay is called Analysis of Infectious Chronic Endometritis, or ALICE, and the Igenomix test uses next-generation sequencing to detect nine different pathogens causing chronic infection: Chlamydia trachomatis, Enterococcus, Escherichia coli, Gardnerella vaginalis, Klebsiella pneumoniae, Mycoplasma hominis, Neisseria gonorrhoeae, Staphylococcus, and Streptococcus. A study was published in the June 2018 issue of the American Journal of Obstetrics and Gynecology.

Integrated LAMP and Immunoassay Platform Detect Diarrheal Disease iotechnologists at the Sandia National Laboratories (Livermore, CA, USA; www.sandia.gov) have developed a syndromic test that combines immunoassays and isothermal amplification-based molecular testing. Essentially a small, fully integrated syndromic panel, the test can go from stool sample to result using the next generation of a platform developed at Sandia called SpinDx. The assay can detect three protein-based enterotoxins as well as DNA of three enteric pathogens. Specifically, it detects cholera toxin, Staphylococcal enterotoxin B, and Shiga-like toxin 1, as well as Campylobacter jejuni, Escherichia coli, and Salmonella typhimurium, in less than one hour. The advantages of this system, in which the heat

Year’s Top 100 Clinical Developments source is spatially separate from the disc, are numerous, including the viability of a simple, low-cost disc, since features such as embedded heating elements or actuation systems for bringing a heater into contact with the disc are not needed. The study was published originally published online on August 10, 2018, in the journal Biosensors and Bioelectronics.

Pneumonia Diagnosed by Nanopore Sequencing of Sputum cientists at Seoul National University Hospital (Seoul, South Korea; www.snuh.org) and their colleagues used deep sequencing of the 16S rRNA gene from sputum to identify H. influenza in a patient with community-acquired pneumonia. They extracted genomic DNA (Genomic DNA Mini Kit (Invitrogen, Carlsbad, CA, USA; www.thermofisher. com) from sputum obtained by oropharyngeal suction after a single empiric administration of an antimicrobial drug (cefuroxime, 500 mg). They generated the sequencing libraries using a rapid 16S amplicon sequencing kit. The authors concluded that with the MinION sequencer, generated reads can be analyzed in real time, which makes this approach more promising. Tentative point-of-care diagnosis by nanopore 16S sequencing and confirmation of the result by standard culture methods would be a feasible approach. They estimated that the turnaround time for MinION 16S sequencing can be reduced to less than eight hours. The study was published in the October 2018 issue of the journal Emerging Infectious Diseases.

OCTOBER New Test Measures Men’s Fertility team of scientists working with Cornell University (Ithaca, NY, USA; www.cornell.edu) collected semen samples from men under medical evaluations due to questions regarding their fertility and processed using Cap Score Male Fertility Assay kits (Androvia LifeSciences LLC, Mountainside, NJ, USA; www.androvialifesciences.com). Alexander J. Travis, VMD, PhD, an Associate Professor of Reproductive Biology and senior author of the study, said, “Out of all the tests commonly used to measure sperm, the Cap-Score is the only one that prospectively has been shown to indicate the probability of a man to generate a pregnancy. This new ability to diagnose a man’s fertility status and ability to generate a pregnancy will let doctors counsel their patients toward a personalized journey to parenthood, using the approaches most appropriate for them.” The study was published on September 24, 2018, in the journal Molecular Reproduction and Development.

Molecular Influenza and Streptococcus Tests Get FDA Clearance he US Food and Drug Administration (Silver Springs, MS, USA; www.fda.gov) has cleared next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The new assays enable fast time-to-results for molecular influenza A & B and Strep A testing at the point of care. Both assays have also been granted CLIA waivers and are available for use with the Abbott ID Now platform (Abbott Diagnostics, Abbott Park, IL, USA; www.molecular.abbott), formerly the Alere I, a rapid, instrument-based, isothermal nucleic acid amplification system for the qualitative detection of infectious diseases. Gregory Berry, PhD, D(ABMM), director of molecular diagnostics at Northwell Health Laboratories (Lake Success, NY, USA; www.northwell.edu), said, “Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance.”

Generic Test for Early Detection of Cancer cientists at the University of Bradford (Bradford, UK; www. bradford.ac.uk) and their collaborators adapted the Lymphocyte Genome Sensitivity (LGS) technique, modified by a slightly different method. To help increase the sensitivity of the test and detect cancer at the level of each individual, they joined with the IMSTAR team (Paris, France; www.imstarsa.com) who analyzed the cells with their fully automated Pathfinder cell reader-analyzer system. The new test, which is called TumorScan, is a highly sensitive test to detect any cancer at an early stage

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through the response of the white blood cells to UV treatment. The authors concluded that their study confirms that the modified method, TumorScan, which combines the adapted Comet assay with different UV treatments, designed and fully automated cell reader-analyzer, the IMSTAR Pathfinder, successfully improves the sensitivity of the original test (LGS test) for the detection of samples at the level of the individual. The study was published on October 12, 2018, in the journal FASEB BioAdvances.

early understanding of the possible cause of death, and to inform potential further post-mortem activities or quickly facilitate police investigations. We matched the coroners’ drug test results obtained using our fingerprint drug screen with a second sample tested in laboratory conditions, achieving excellent correlation in terms of accuracy. We also compared our results with toxicological analysis of blood and urine samples, with a good correlation of results.” The study was published in the October 1, 2018, online edition of the Journal of Analytical Toxicology.

Cancer Liquid Biopsy Assay Detects Low-Level Mutations

NOVEMBER Blood Compatibility Assay Approved by FDA

cell-free DNA assay has been developed to detect low-frequency mutations in colorectal cancer. The assay initially is to be used for translational studies but a clinical version of the test is under development that might also be applicable to lung and other cancers. An international team of scientists working with the Institute of Cancer Research (London, UK; www.icr.ac.uk) has developed a customizable hybrid-capture cfDNA-Seq technology using off-the-shelf molecular barcodes and a novel duplex DNA molecule identification tool for enhanced error correction. Marco Gerlinger, MD, a clinical scientist and senior author of the study, said, “We’re interested in discovering resistance mechanisms and new drivers of metastatic disease, so we needed the option of changing around what we want to include in our sequencing assay. While commercially available assays that make use of amplicon technology are customizable, the team also wanted the ability to look at genome-wide copy number alterations, which can be more challenging with amplicon-based assays than with hybrid capture-based ones.” The study was published in the October 2018 issue of the journal Clinical Chemistry.

he US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) announced that it has approved a molecular assay to determine blood compatibility for blood transfusions. The ID CORE XT (Progenika Biopharma, Bizkaia, Spain; www.progenika.com) is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results. ID CORE XT is a qualitative, polymerase chain reaction (PCR)-based and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test genotypes 29 polymorphisms determining 37 HEA phenotypes of blood group systems. Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said, “The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera. We know that DNA testing holds great promise, to provide more informative, accurate and cost-effective methods that can enhance patient care.”

Rapid Test Detects Drugs of Abuse in Fingerprint Samples

Diagnostic Test Aids Determination Of Menopausal Status

rapid lateral flow assay accurately detects drugs of abuse in finger print samples from living or deceased individuals. Investigators at the University of East Anglia (Norwich, UK www.uea.ac.uk) and the biotechnology company Intelligent Fingerprinting (Cambridge, United Kingdom; www.intelligentfingerprinting.com) developed a fluorescence based lateral flow competition assay for the screening of four classes of drugs: delta9-tetrahydrocannabinol (THC), cocaine (through the detection of benzoylecgonine, BZE), opiates (through the detection of morphine, MOR) and amphetamine (AMP) present in the sweat of a fingerprint. This “Drug Screening Cartridge” was specifically developed for fingerprint sample collection and analysis. Senior author Dr. David Russell, emeritus professor of chemistry at the University of East Anglia, said, “Our study also showed how our technology is being used by coroners to assist in gaining

he US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) has approved marketing of an enzyme-linked immunosorbent assay diagnostic test as an aid in the determination of a patient’s menopausal status. The PicoAMH ELISA test (Ansh Labs, Webster, TX, USA; www.anshlabs.com) measures the amount of Anti-Müllerian Hormone (AMH) in the blood. AMH levels represent an indicator available to clinicians to determine whether a woman is approaching or is likely to have reached her final menstrual period. The PicoAMH Elisa test is meant for use only in conjunction with other clinical assessments and laboratory findings. The data from the FDA review showed that the PicoAMH Elisa test performed reasonably well at determining levels of AMH in the blood and identifying women who had their last menstrual period and women who were more than five years away from their last menstrual period. Courtney Lias, PhD, from the

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Year’s Top 100 Clinical Developments FDA, said, “Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms. This test, when used in conjunction with other clinical assessments and laboratory findings, can help inform discussions about preventative care, such as ways to help prevent loss in bone mineral density or to address cardiovascular disease, both of which are known to increase after menopause.”

Genetic Test Helps Patients Avoid Unnecessary Thyroid Surgery large team of scientists collaborating with the University of Pittsburgh School of Medicine (Pittsburgh, PA, USA; www.medschool. pitt.edu) used the ThyroSeq v3 Genomic Classifier (GC) (ThyroSeq, Oakland, PA, USA; https://thyroseq.com) which is a targeted nextgeneration sequencing test that interrogates selected regions of 112 thyroid cancer-related genes for point mutations, insertions/deletions, gene fusions, copy number alterations, or gene expression alterations. David Steward, MD, a professor of otolaryngology and first author of the study, said, “Beyond simply differentiating benign and malignant nodules, the study shows that ThyroSeq also provides a detailed genetic profile of the positive nodules. Since thyroid cancer is known to progress differently based on the mutation involved, ThyroSeq potentially allows physicians to employ a precision medicine approach, modifying treatment for each patient based on the mutations present.” The study was published on November 8, 2018, in the journal JAMA Oncology.

tralia; www.adelaide.edu.au) and Griffith University (Gold Coast, Australia; www.griffith.edu.au) demonstrated the utility of SubB2M to detect Neu5Gc tumor biomarkers in sera from patients with ovarian cancer. Using surface plasmon resonance (SPR), they showed that SubB2M could detect the established ovarian cancer biomarker, CA125, in a highly sensitive and specific fashion in the context of human serum. “Ovarian cancer is notoriously difficult to detect in its early stages, when there are more options for treatment and survival rates are better. Our new test is therefore a potential game changer,” said contributing author Dr. James Paton, director of the research center for infectious diseases at the University of Adelaide. The new test for ovarian cancer was described in the November 8, 2018, online edition of the journal Biochemical and Biophysical Research Communications.

Phenotypic Test Identifies Antibiotic-Resistant Bacterial Infections he BD Phoenix CPO detect test (Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com) has gained US Food and Drug Administration (FDA, Silver Springs, MD, USA; www. fda.gov) clearance. The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs,

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cientists from the Cancer Research UK (Cambridge, UK; www. cancerresearchuk.org) used untargeted, low coverage whole genome sequencing (< 0.4×) to detect somatic copy number alterations (SCNAs) in cell free DNA in the CSF of glioma patients. Combining analyses of these SCNAs with DNA fragmentation patterns determined using paired end sequencing allows detection of cftDNA in CSF using shallow whole genome sequencing (sWGS) data. Florent Mouliere, PhD, the first co-author of the study said, “Liquid biopsies are showing great promise for a number of cancer types, but tests for brain tumors have lagged behind due to the low levels of tumor DNA found in body fluids, in particular the blood. Our work shows that a cheap, easily available technique can be used to analyze tumor DNA in cerebrospinal fluid. In the future, we envisage that this technique could be used to identify patients who may benefit from further tests that could help monitor their disease, opening up more tailored treatment approaches.” The study was published on November 6, 2018, in the journal EMBO Molecular Medicine.

Ovarian Cancer Test Measures Biomarker Serum Levels new blood test for the diagnosis of ovarian cancer measures serum levels of the biomarker Nglycolylneuraminic acid (Neu5Gc). Investigators at the University of Adelaide (Aus-

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Annual Review 2018 thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections. Kenneth Thomson, PhD, clinical professor of Pathology and Laboratory Medicine at the University of Louisville School of Medicine (www.louisville.edu) said, “The BD Phoenix CPO detect test is a completely new type of phenotypic test, and its range of automation and diagnostic capabilities is unmatched by all other currently marketed tests. It represents a significant advance in meeting an important clinical need for rapid detection of CPOs.”

Ultrasensitive Screening Platform Detects Pathogenic Bacteria diagnostic platform has been developed that significantly increases the sensitivity of high-throughput sequencing for detection and characterization of bacteria, virulence determinants, and antimicrobial resistance (AMR) genes. Investigators at Columbia University (New York, NY, USA; www.columbia.edu) recently described the BacCapSeq (bacterial capture sequencing) system, which was designed to complement the earlier VirCapSeq test that screens for all known human viral infections. The BacCapSeq system is based on a probe set comprising 4.2 million oligonucleotides extracted from the Pathosystems Resource Integration Center (PATRIC) database, the Comprehensive Antibiotic Resistance Database (CARD), and the Virulence Factor Database (VFDB).

Highly Multiplexed Broad Pathogen Assay Detects Infectious Diseases cientists at the United States Army Medical Research Institute of Infectious Diseases (Fort Detrick, MD, USA; www.usamriid. army.mil) developed a highly multiplexed assay designed to detect 164 different viruses, bacteria, and parasites using the NanoString nCounter platform (Seattle, WA, USA; www.nanostring.com). Included in this assay were high consequence pathogens such as Ebola virus, highly endemic organisms including several Plasmodium species, and a large number of less prevalent pathogens to ensure a broad coverage of potential human pathogens. The team used the Broad Pathogen Detection Assay (BPDA) for use with the NanoString nCounter platform in order to quickly screen a sample for multiple pathogens in a single tube reaction. The authors concluded that this assay could improve infectious disease diagnostics and biosurveillance efforts as a quick, highly multiplexed, and easy to use pathogen-screening tool. The study was published on November 5, 2018, in the journal Public Library of Science Neglected Tropical Diseases.

Year’s Top 100 Clinical Developments Phenotypic Test Identifies Antibiotic-Resistant Bacterial Infections he BD Phoenix CPO detect test (Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com) has gained US Food and Drug Administration (FDA, Silver Springs, MD, USA; www. fda.gov) clearance. The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections. Kenneth Thomson, PhD, clinical professor of Pathology and Laboratory Medicine at the University of Louisville School of Medicine (www.louisville.edu) said, “The BD Phoenix CPO detect test is a completely new type of phenotypic test, and its range of automation and diagnostic capabilities is unmatched by all other currently marketed tests. It represents a significant advance in meeting an important clinical need for rapid detection of CPOs.”

Liquid Biopsy Detects Cancer Across Multiple Biomarkers large international team of scientists led by those at the Karolinska Institute (Stockholm, Sweden; https://ki.se) sequenced cell-free DNA blood samples taken from prostate cancer patients with metastatic, castration-resistant disease, using a combination of targeted and low-pass whole-genome sequencing. Germline DNA was extracted from leftover EDTA blood. In addition, for circulating DNA (ctDNA)-analyzed blood samples, an additional blood sample was collected in a CellSave tube and shipped to the GZA Sint-Augustinus (Antwerp, Belgium; www.gza.be) for circulating tumor cells (CTC) enumeration within 72 hours on the FDA-cleared CellSearch platform (Menarini Silicon Biosystems, Castel Maggiore, Italy; www.siliconbiosystems.com). The authors concluded that ctDNA profiles appear to mirror the genomic landscape of metastatic prostate cancer tissue and may cost-efficiently provide somatic information in clinical trials designed to identify predictive biomarkers. However, intronic sequencing of the interrogated tumor suppressors challenges the ubiquitous focus on coding regions and is vital, together with profiling of synchronous white blood cells, to minimize erroneous assignments which in turn may confound results and impede true associations in clinical trials. The study was published on November 21, 2018, in the journal Genome Medicine.

DECEMBER Metagenomic Sequencing Proposed for Respiratory Tract Infection Detection ower respiratory tract infections (LRTIs) are the leading cause of infectious disease-related deaths worldwide yet remains challenging to diagnose because of limitations in existing microbiologic tests. A multidisciplinary team of scientists at the University of California, San Francisco (CA, USA; www.ucsf.edu) addressed the need for better lower respiratory tract infection diagnostics by developing a metagenomic next-generation sequencing-based method that integrates host response and unbiased microbe detection. They then evaluated the performance of this approach in a prospective cohort of critically ill patients with acute respiratory failure. From these data, they suggested that it is possible to bring together pathogen, microbiome diversity, and host gene expression metrics to identify LRTI-positive patients and differentiate them from critically ill controls with non-infectious acute respiratory illnesses. The study was published on November 27, 2018, in the journal Proceedings of the National Academy of Sciences.

Tau Blood Test Developed For Alzheimer’s Disease resently, the only way to definitively diagnose Alzheimer’s disease in life is through brain scans and tests of cerebrospinal fluid that must be collected via lumbar puncture. A team of scientists working with those at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) developed a set of immunoassays to meas-

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Year’s Top 100 Clinical Developments ure tau in specimens from humans diagnosed based on current best clinical and cerebrospinal fluid (CSF) biomarker criteria. The developed tests were capable of detecting different populations of tau fragments in cerebrospinal fluid and blood. Dominic M. Walsh, PhD, a Lecturer on Neurology and corresponding author of study said, “A blood test for Alzheimer’s disease could be administered easily and repeatedly, with patients going to their primary care office rather than having to go into a hospital. Ultimately, a blood-based test could replace cerebrospinal fluid testing and/or brain imaging. Our new test has the potential to do just that. Our test will need further validation in many more people, but if it performs as in the initial two cohorts, it would be a transformative breakthrough.” The study was published on November 9, 2018, in the journal Alzheimer’s & Dementia.

Newborn Cytomegalovirus Test Cleared for Marketing ytomegalovirus or CMV is a common virus that infects people of all ages. In the USA, nearly one in three children are already infected with CMV by age five and over half of adults by age 40 have been infected with CMV. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) announced that it has completed the de novo premarket review and cleared for marketing Meridian Bioscience’s (Cincinnati, OH, USA; www.meridianbioscience.com) cytomegalovirus assay for newborns called the Alethia CMV Assay Test System. A prospective clinical study showed the Alethia test correctly identified 1,472 out of 1,475 CMV negative samples. The Alethia CMV test system enables detection of CMV DNA from saliva swabs of newborn babies who are less than 21 days old. The FDA specified that test results must be used in conjunction with the results of other diagnostic tests and clinical information.

apy is crucial to overcoming the cancer.” The study was published on October 30, 2018, in the journal BMC Medical Genomics.

Less-Invasive Biosensor Created For Breast Cancer Diagnosis ioengineers at the University of Hartford (West Hartford, CT, USA; www.hartford.edu) and their colleagues have devised a new biosensor to diagnose breast cancer less invasively compared to the existing needle biopsy approach. The device combines microfluidic technology and diagnostics, and was partly built using an inkjet printer. The printed chip, consisting of an array of electrodes, was deposited into a prefabricated microfluidic device that regulates fluids to flow in a controlled manner. Seila Selimovic, PhD, from the National Institute of Biomedical Imaging and Bioengineering (Bethesda, MD, USA; www.nibib.nih.gov) said, “Less invasive, more accessible, and faster diagnostic tools like this biosensor are essential to improving healthcare. As biosensors continue to progress it is important to keep in mind diagnostic tools are only helpful when accurate. This biosensor works in the clinically relevant range and has one of the lowest reported HER-2 detection limits, so fewer false positives and negatives will occur.”

Genetic Marker Predicts Early Relapse in Pediatric Acute Lymphoblastic Leukemia cute lymphoblastic leukemia (ALL) is the most common childhood cancer; however, treatment has improved dramatically due to the ability to stratify patients into groups based on risk factors and genetic analysis. Scientists at the Nova Southeastern University (Fort Lauderdale, FL, USA; www.nova.edu) and their associates discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists can determine the likelihood of early relapse (less than three years) in their acute lymphoblastic leukemia (ALL) patients. The Affymetrix Human Genome U133 plus 2 array (Affymetrix, Santa Clara, CA, USA; www.affymetrix.com) was used to generate both datasets. Jean Latimer, PhD, an associate professor and oncology scientist, said, “Our study found a correlation between high NER expression levels and early relapses of ALL among relapsing patients. Being able to identify patients with the highest risk of early recurrence who are not detectable using present clinical measures and then treating them with a more targeted ther-

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Annual Review 2018 Tick-Borne Diseases Diagnosed With Multiplex Molecular Panel lthough Lyme disease is the most prevalent tick-borne infection in the USA, experts are seeing more serious tick-borne illnesses, some of them fatal if not treated right away. It’s difficult to predict from year to year how many cases of tick-borne diseases will be reported in the USA. ChromaCode Inc (Carlsbad, CA, USA; https://chromacode.com) has launched a nine-target, quantitative polymerase chain reaction (qPCR) panel test that can detect a total of 12 species that are typically transmitted to humans by ticks in various regions of the USA. The core technology, called high-definition PCR (HDPCR), enables standard thermal cyclers to run multiplexed panel tests. Essentially, it modifies standard TaqMan chemistry to create unique curve signatures depending on the targets present, with specialized, user-friendly, cloud-based software to deconvolve and interpret the curves. The results were presented at the Association for Molecular Pathology meeting held November 1-3, 2018, San Antonio, TX, USA.

Year’s Top 100 Clinical Developments Banna Virus Detected by Reverse Transcription-Loop-Mediated Isothermal Amplification anna virus (BAV) has been isolated from a diverse group of vertebrates and invertebrates, including mosquitos, ticks, midges, cattle, and pigs from different regions in China, Vietnam, and Indonesia. BAV is considered to be an emerging pathogen that can result in human infections with possible manifestation of fever and viral encephalitis. Scientists at the Wuhan Institute of Virology (Wuhan, China; www. whiov.cas.cn) concluded that they had successfully developed a RT-LAMP assay for the detection of BAV, which provides a potential new molecular diagnostic test for BAV that could be applied in the field or clinic in the future, and that may contribute to the preparedness for future outbreaks of a BAV endemic, especially for regions with limited resources available. The study was published online on November 2, 2018, in the International Journal of Infectious Diseases.

Neuroblastoma Molecular Analysis Leads to Prognostic Markers large team of scientists working with the University Hospital of Cologne (Cologne, Germany; www.uk-koeln.de) investigated molecular features of divergent tumor subtypes, and performed genome sequencing on pretreatment neuroblastomas, and assessed telomere maintenance mechanisms in half of these tumors. The investigators found that patients whose tumors lacked telomere maintenance mechanisms had an excellent prognosis, whereas the prognosis of patients whose tumors harbored telomere maintenance mechanisms was substantially worse. Survival rates were lowest for neuroblastoma patients whose tumors harbored telomere maintenance mechanisms in combination with RAS and/or p53 pathway mutations. Spontaneous tumor regression occurred both in the presence and absence of these mutations in patients with telomere maintenance–negative tumors. The authors concluded that assessment of telomere maintenance mechanisms and a limited set of RAS and TP53] pathway genes may be sufficient to accurately estimate patient risk at diagnosis and to guide treatment stratification. In a clinical setting, telomerase activation may be readily determined by examining the genomic status of MYCN and TERT in the majority of cases and supplemented by analysis of TERT expression levels in MYCN-wild type and TERT-wild type tumors. The study was published on December 7, 2018, in the journal Science.

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ALPHABETICAL LISTING OF COMPANIES fer lab-based assays to lateral flow assays.

AccuBio Tech 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

China • Beijing Tel: (86) 10-8048-4980 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.

Accumax Lab Technology

Abaxis

Acon Laboratories

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 on-the-spot results and offer built-in 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.

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

Abbott Diagnostics

Adaltis

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, he-matology, automation, molecular and remote diagnostics.

Abingdon Health UK • York Tel: (44) 0-1904-406-082 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 trans-

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

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

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

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

affinitybiologicals.com Manufactures antibodies, purified proteins, control plasmas, calibrator plasmas, ELISA kits, and factor-deficient plasmas prepared by immunoaffinity chromatography.

and platelet aggregation to serve the research projects and the needs of the academic and industrial sectors.

Agro-Bio

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.

A Stago Company France • La Ferté Saint-Aubin Tel: (33) 238-648-350 Web: agro-bio.com Specializes in biotechnological solutions and high quality products for immunotechnology, protein biochemistry,

Agappe Diagnostics Switzerland

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.

Aeon Technology China • Shenzhen Tel: (86) 755-2650-9160 Web: aeon-med.com E-mail: market@aeon-med.com Designs and produces clinical diagnostic equipment, as well as containers and disposables.

AESKU Diagnostics Germany • Wendelsheim Tel: (49) 6734-9622-0 Web: aesku.com E-mail: sales@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) 73-212-6155 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@

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

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Argentina • Buenos Aires Tel: (54) 11 45234848 Web: aadee.com E-mail: info@aadee.com.ar 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 “AADEEZEN” ISE that has the capability to measure Na, K, Cl, and Ca.

India • 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 variable-volume and fixed-volume micropipettes, minipipettes, spares, and micropipette stand.

WORLD’S IN VITRO DIAGNOSTICS COMPANIES

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LabMedica 300 AirClean Systems

Alifax

USA • Creedmoor, NC Tel: (1) 919-255-3220 Web: aircleansystems.com E-mail: sales@ aircleansystems.com Manufactures fume hoods, enclosures, and workstations designed to protect the operator or process from potentially harmful fumes, vapors, gases, and particulate.

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.

Alfa Scientific Designs 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-ofcare marketplace. The company focuses on rapid immunoassays including those for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac and cancer markers.

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.

AMEDA Labordiagnostik Austria • Graz Tel: (43) 316-698069

Web: amp-med.com E-mail: office.graz@ampmed.com Offers a range of products known under the AMP Diagnostics brand, including kits and equipment for clinical chemistry, immunology, hematology and coagulation, as well as urine and rapid diagnostics.

Web: apacor.com E-mail: info@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.

American Biochemical & Pharmaceuticals

Apel

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

Ameritek USA

AMS Alliance Visit us at

MEDLAB

Stand Z1.C32

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

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

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

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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.

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

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

Apacor

Association of Public Health Laboratories

UK • Wokingham, Berkshire Tel: (44) 118-9795566

USA • Silver Spring, MD Tel: (1) 240-485-2745 Web: aphl.org

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

AVE Science & Technology China • Changsha 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.

Astell Scientific 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 highcontainment laboratories.

Astra Biotech Germany • Berlin 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.

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

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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.

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

E-mail: info@aphl.org Provides laboratory continuing education on a variety of topics, including live, cost-effective webinars, and access to CEUs for lab personnel.

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AXIOM Solutions

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

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

Autobio Diagnostics

Germany • Bürstadt Tel: (49) 6206-6012 Web: axiom-solutions.de E-mail: info@axiom-solutions.de Manufactures and supplies serology, immunology, urine analysis and ELISA (EIA) instruments for laboratory and hospitals. The company also offers a complete range of Powervision and surgical microscopes for use in hospital and lab industries, as well as universities and schools.

BBI Solutions UK • Crumlin Tel: (44) 0-1495-363000 Web: bbisolutions.com Supplies diagnostic and therapeutic reagents and conjugates, gold and silver labeling of proteins and oligonucleotides, as well as quality control sera for molecular diagnostic tests.

BD Diagnostics

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

AutoGenomics USA • Carlsbad, CA Tel: (1) 760-477-2248 Web: autogenomics.com E-mail: international@ 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.

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

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LabMedica 300 Scienceware, PLUM, Sterileware, Magic Touch, Secador and H-B Instrument.

Benchmark Scientific

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

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BioFire Diagnostics 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.

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Berthold Technologies

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

Biomat

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.

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

Bio-Rad Laboratories

Biomedical Polymers

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

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

BIOKIT Spain • Llissa d’Amunt Tel: (34) 93-860-90-00 Web: biokit.com

USA • Sterling, 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: info@biomerica.com Develops, manufactures, and sells products designed to detect diseases in the areas of cancer, cardiology, fertility, gastroenterology, diabetes, allergy, and infectious diseases.

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

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

Biosearch Technologies USA • Petaluma, 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) 04-26-302226 Web: biosigma.com E-mail: export@biosigmaeu.com Specializes in the production of optical multisample cuvettes and cups, as well as a wide range of disposable labware.

BioSystems Spain • Barcelona Tel: (34) 93-311-00-00 Web: biosystems-sa.com Develops and manufactures reagents and instru-

China • Nanchang Tel: (86) 791-8816-8831 Web: biotech.com.cn E-mail: overseas@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: mlepri@biotecnica.it Designs and manufactures standard and OEM clinical chemistry equipment and relevant reagent products intended for private and state clinical laboratories including photometers, automatic analyzers, and ion selective analyzers.

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

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.

native 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: export@bcbmcn.com Manufactures in vitro rapid test kits. Main products include the test strips and cassettes for fertility, hepatitis B&C, drugs of abuse, infectious diseases, tumor marker, and sexually transmitted diseases.

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

Bühlmann Laboratories Switzerland • Schönenbuch Tel: (41) 61-487-12-12 Web: buhlmannlabs.ch E-mail: info@buhlmannlabs.ch Develops, manufactures and sells in-vitro diagnostic assays, including automated solutions and rapid tests.

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

ments for clinical analysis.

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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.

E-mail: biokit@biokit.com Develops and manufactures OEM immunoassays and biomaterials for global IVD companies. The company specializes in infectious disease serology, and offers products that implement different technologies including chemiluminescence.

Block Scientific USA • Bellport, NY Tel: (1) 631-589-1118 Web: blockscientific.com E-mail: info@blockscientific.com Provides reconditioned laboratory equipment as an alter-

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

Visit us at: Stand Z6.F44

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

BioPorto Diagnostics 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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analyzers and relative reagents worldwide.

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.

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

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

CANDOR Bioscience 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 New Zealand • Christchurch

LabMedica 300

Caretium Medical Instruments China • Shenzhen Tel: (86) 755-2527-3885 Web: en.caretium.com E-mail: info@caretium.com Develops and manufactures products that include biochemistry analyzers, microplate readers, electrolyte analyzers, and erythrosedimentation rate analyzers.

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

Carl Zeiss MicroImaging Germany • Jena Tel: (49) 3641-64-3161 Web: zeiss.de/micro

USA • Greensboro, NC Tel: (1) 336-722-8910 Web: carolinachemistries.com E-mail: contactsales@carolinachemistries.com Manufactures bar-coded chemistry reagents, parts, supplies, and service for use on Beckman Synchron and the Olympus AU series of instruments.

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

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

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

Cepheid 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.

Certest Biotec Spain • San Mateo de Gallego Tel: (34) 976-520-354 Web: certest.es E-mail: certest@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.

CellaVision

Chembio Diagnostic Systems

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

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

Chemclin Biotech China • Beijing Tel: (86) 10 5871 7511 Web: chemclin.com E-mail: info@chembio.com Develops diagnostic reagents covering chemiluminescence assays and clinical chemistry assays. The company also offers commercial testing services for infectious diseases, tumor, thyroid, diabetes, fertility, and liver fibrosis.

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Germany • Nordhausen Tel: (49) 0-3631-65242-0 Web: capp.dk E-mail: info@capp.dk Develops and manufactures laboratory liquid handling instruments. Products include pipettes, pipette tips, and microplate washers.

Carolina Liquid Chemistries

diseases such as infection and cancer.

SEE AD ON PAGE 13

Chemtron Biotech China • Shanghai Tel: (86) 21-6812-9666 Web: chemtronbio.com E-mail: international@ chemtronbio.com Specializes in the development, manufacture and marketing point-of-care (POC) in vitro immunodiagnostic rapid tests for the detection and management of pregnancy, ovulation fertility, infectious diseases, cancers, drugs of abuse, myocardial tissue damage and the onset of menopause. Sample formats include test strips, cassettes, midstream, and cups.

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

CLONIT Italy • Milan Tel: (39) 02-5681-4413 Web: clonit.it E-mail: info@clonit.it Develops products for in vitro diagnostics with particular attention to the detection of viral, bacteria, and proto-

zoa infections, genetic mutations, and oncological diseases. Products available include ready-to-use diagnostic kits that are userfriendly for routine diagnostic laboratories.

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

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

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

Cormay Poland • Lomianki Tel: (48) 22-751-79-10 Web: cormay.pl E-mail: international@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.

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.

Crony Instruments Italy • Rome Tel: (39) 6-4396432 Web: crony.com E-mail: mail@crony.it Markets and sells automatic and semi-automatic analyzers, and develops and produces analyzers on an OEM basis. LINKXPRESS COM

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CTK Biotech USA • San Diego, CA Tel: (1) 858-457-8698 Web: ctkbiotech.com E-mail: info@ctkbiotech.com Develops and manufactures innovative rapid tests, ELISA kits, and external controls.

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Capp

E-mail: info.microscopy.de@ zeiss.com Specializes in the optical and optoelectronic industries. The company products for semiconductor and optoelectronic technology, life sciences, healthcare, and eye care.

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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.

SEE AD ON PAGE 44

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

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

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

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

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

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

Deltalab Spain • Barcelona Tel: (34) 93-699-5000 Web: deltalab.es E-mail: deltalab@deltalab.es

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LabMedica 300

Denka Seiken

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.

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

DIA.PRO Diagnostic Bioprobes

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

Dialab

Diagast

Diamedix

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.

An Erba Mannheim Company

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

Diagnosticum Hungary • Budapest Tel: (36) 1-369-07-39 Web: diagnosticum.hu E-mail:

Diametra Italy • Perugia Tel: (39) 0742-24-851 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

LabMedica International December/2018-January/2019

SEE AD ON PAGE 32

Dirui Industrial China • Changchun Tel: (86) 431-8508-3721 Web: dirui.com.cn E-mail: dirui@dirui.com.cn Specializes in R&D and manufacturing of products for urine analyzers, including urine strips.

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 analyz-

USA • Springfield, NJ Tel: (1) 973-564-7555 Web: drg-international.com E-mail: corp-office@ drg-international.com Provides complete range of products and services to the diagnostics and cardiologyrelated medical community. The company is constantly looking towards the future in

order to continue to produce and distribute the highestquality diagnostic products in clinical chemistry, immunology and microbiology that are cutting edge, easyto-use and effective.

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.

DLAB Scientific China • Beijing Tel: (86) 10-6049-8800 Web: dlabsci.com E-mail: info@dlabsci.com Manufactures laboratory instruments for researchers in both the scientific and clinical fields, focusing on two

SEE AD ON PAGE 8

Germany • Holzheim Tel: (49) 6432-9146-0 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. SEE AD ON PAGE 16

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

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

Diesse Diagnostica Senese Italy • Siena Tel: (39) 05-77-319560 Web: diesse.it LINKXPRESS COM

SEE AD ON PAGE 45

DNA Genotek

DiaSys Diagnostic Systems

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China • Hong Kong Tel: (852) 2147-4088 Web: diagcorlifescience.com E-mail: sales@diagcorlifescience.com Dedicated solely to the business of MDx, the company is a global leader in flowthrough hybridization technology, offering a wide range of products, solutions and services in the area of RNA and DNA rapid analysis.

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

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

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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.

DIAsource ImmunoAssays

ers, software, electrodes, and consumables.

DRG International

Diestro

SEE ADS ON PAGE 31, 33

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.

DiagCor Life Science Limited

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.

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.

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Diagnostica Stago

Diagon

DFI

Tel: (82) 2912-7933 Web: diaprobe.com Develops and manufactures real-time PCR kits for clinical chemistry and POC testing.

DiaSorin

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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, Norwalk-like and influenza viruses.

mail@diagnosticum.hu Develops and markets biochemistry reagents and immunology kits, with applications for open analyzers.

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Manufactures a range of containers and disposables, along with pipettes and liquid handling systems.

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LabMedica 300 ments, including the Agility automated system with SmartKit technology. As a leader in automated microplate technology, the company offers the new Multiplier with SmartPLEX technology.

DxGen

EastCoast Bio

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

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.

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.

Dynex Technologies USA • Chantilly, VA Tel: (1) 703-631-7800 Web: dynex.com E-mail: productinfo@dynex.com Designs and manufactures innovative ELISA instru-

China • Shenzhen Tel: (86) 755-3689-9033 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.

UK • Cardiff Tel: (44) 29-20-710570 Web: ekfdiagnostics.com E-mail: info@ ekfdiagnostics.com Focuses on the POC market with over 80,000 hemoglobin, HbA1c, glucose and lactate analyzers in regular use in more than 100 countries running more than 70m tests every year. The company is also a global manufacturer of central lab products including Stanbio chemistry reagents. SEE AD ON PAGE 43

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.

Erba Diagnostics Mannheim Germany • Mannheim Tel: (49) 621-8799770 Web: erbamannheim.com E-mail: sales@ 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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SEE AD ON PAGE 48

SEE AD ON PAGE 11

Emperor Electronic Technology

EKF Diagnostics

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

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

SEE ADS ON PAGE 5, 7

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

sumables, 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 high-throughput 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@erbemannheim.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.pt E-mail: info@topstar.pt Develops, manufactures and distributes a wide range of hospital, clinical lab, safety and hygienic products. The company created the Toplabs catalog, which includes quality products such as TopStar glucose solution, ZeroDNA and Mycoplasmafree.

Eurobio France • Les Ulis Tel: (33) 1 69 07 94 77 Web: eurobio.fr E-mail: info@eurobio-ingen.com Develops, produces and

sells a complete range of reagents and biochemicals for the diagnostic and research markets.

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

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

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Dymind Biotech

ELITech Group

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product lines: liquid-handling devices – including mechanical electronic and autoclavable pipettes, and pipetting aids – and diagnostic instruments, such as erythrocyte sedimentation rate analyzers.

SEE AD ON PAGE 47

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

Eurotrol Netherlands • Ede Tel: (31) 318-695-777 Web: eurotrol.com E-mail: office@eurotrol.com Provides QC materials to the diagnostic laboratory market, EQA/PT programs, standardization bodies, hospital labs, and POC.

Express Diagnostics International

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.

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

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

FUJIFILM Wako Pure Chemical Corporation Japan • Osaka Tel: (81) 6-6203-3741 Web: ffwk.fujifilm.co.jp Develops and manufactures products for three areas: laboratory chemicals, specialty chemicals, and diagnostic reagents.

Fujirebio Diagnostics USA • Malvern, PA Tel: (1) 610-240-3800 Web: 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.

Gardner Denver

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.

LINKXPRESS COM

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.

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

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

General Biologicals Taiwan • Hsin Chu Tel: (886) 3-577-9221 Web: gbc.com.tw E-mail: sales.group@gbc.com.tw Develops and manufactures

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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-ofcare market.

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.

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

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SEE AD ON PAGE 9

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

Globe Scientific USA • Mahwah, 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

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: export@ 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 • Taizhou Tel: (86) 576-8411-5678 Web: chinagongdong.com Manufactures and distributes disposable medical and lab consumables.

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

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 market-

LabMedica International December/2018-January/2019

ing a range of clinical diagnostic assays and kits including niche products like oxalate test, and pyruvate kinase deficiency test. SEE AD ON PAGE 20

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) 532-8893-7380 Web: haiermedical.com E-mail: xiangju.li@haierbiomedical.com Specializes in the design, manufacturing, and marketing of a range of scientific products, such as low-temperature freezers, for various lab applications.

croscopic and staining utensils, liquid handling, water treatment, measuring glass instruments, as well as general lab apparatus, and hydrometers and thermometers.

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GeneReach Biotechnology

provides custom kit assembly, private label, and custom molding services.

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high-quality IVD and pharmaceutical products for doctors to make clinical decisions in the area of hepatitis, tumor markers, retrovirus, fertility, thyroid and steroids. In general consumables, the company also provides an anti-bacterial peptide in areas of pharmaceutical, cosmetics and oral products.

SEE AD ON PAGE 30

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 Sweden • Angelholm Tel: (46) 77-570-02-10 Web: hemocue.com E-mail: info@hemocue.se Develops, produces, and markets products for pointof-care testing. The company’s leading products measure hemoglobin and glu-

cose in whole blood and albumin in urine.

Hemosure USA • Irwindale, CA Tel: (1) 888-436-67873 Web: hemosure.com E-mail: sales@hemosure.com Manufactures the Hemosure Immunological Fecal Occult Blood test (IFOBT) that offers high sensitivity and high specificity, and is easily performed in physician offices, hospitals, and labs.

Hettich Germany • Tuttlingen Tel: (49) 7461-705-0 Web: hettichlab.com E-mail: info@hettichlab.com Provides customers with a complete line of centrifuges. Product applications include clinical chemistry, hematology, cytology and hystology. Centrifuge varieties include

microliter, hematocrit, benchtop, underbench, floor-standing, blood bank, robotic centrifuges, refrigerated and nonrefrigerated and cell washers.

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

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

Hanlab Korea • Cheongju 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.

Visit us at

MEDLAB

Stand Z3.B33

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

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

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

Hecht - Assistent Germany • Sondheim Tel: (49) 9779-808-0 Web: hecht-assistent.de E-mail: info@hecht-assistent.de Offers products for blood tests and urine analysis, miLINKXPRESS COM

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LabMedica 300 Hologic

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

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

Horron XLH Medical

Tel: (1) 317-454-8685 Web: hycorbiomedical.com E-mail: info@hycorbiomedical.com Develops, manufactures and markets automated instruments and reagent systems. The company also offers a line of urinalysis controls and disposable products under the Kova brand.

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

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

HTL

Immucor Gamma

iCubio Biomedical Technology

Poland • Warsaw Tel: (48) 22-492-19-00 Web: htl.com.pl E-mail: htl.customercare@corning.com 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.

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.

Human Diagnostics

USA • Marlborough, 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.

Korea • Anyang Tel: (82) 31-478-8591 Web: humasis.com E-mail: question@humasis.com Develops and manufactures products for IVD and pointof-care testing.

Hycor Biomedical USA • Garden Grove, CA

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

USA • Minneapolis, MN Tel: (1) 763-780-2955 Web: ibl-america.com E-mail: info@ibl-america.com Provides high-quality laboratory reagent assays for research and clinical testing in various areas including autoimmunity, endocrinology, infectious disease, oncology and neuroscience. Products include ELISA kits, RIA kits, chemiluminescent diagnostic and research tools, antibodies and proteins.

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

Humasis

Immunodiagnostic Systems

IBL-America

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.

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

protein colorimetric microarray containing 10 DNA/ENA antigens.

Immunetics

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

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

Inova Diagnostics USA • San Diego, CA Tel: (1) 858-586-9900 Web: inovadx.com E-mail: support@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.

Instrumentation Laboratory USA • Bedford, MA Tel: (1) 781-428-0535 Web: instrumentation laboratory.com E-mail: egoodnow@ilww.com Specializes in innovative hemostasis and acute care IVD testing solutions such

as the new GEM Premier 5000 system with iQM2; new GEMweb Plus 500 custom connectivity; GEM Premier 4000/3500 systems; ACL TOP Family 50 Series systems; HemoCell specialized lab automation; HemoHub intelligent data manager; ACL AcuStar system and HemosIL assays. Recent TEM/Accriva acquisitions expanded the product portfolio with ROTEM patient blood management; Hemochron; VerifyNow and Avoximeter systems.

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USA • Marlborough, MA Tel: (1) 508-263-2900 Web: hologic.com E-mail: customersupport@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.

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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.

InTec Products China • Xiamen Tel: (86) 592-680-7100 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 ImmunoDiagnostics 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 onestep membrane quick screen tests.

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

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

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

JAJ International USA • San Diego, CA Tel: (1) 858-866-0788 Web: jajinternational.com E-mail: info@ jajinternational.com Develops, manufactures, and markets a wide range of one-step 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.

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: k-assay.com E-mail: info@k-assay.com Manufactures over 38 immunoassay reagents for chemistry analyzers including the new H. pylori reagent and remnant lipoprotein cholesterol reagent for chemistry analyzers. The reagents offer the best performance / lowest price of any comparable reagents, and are available for lipid, diabetes/stroke, anemia, allergy, inflammation, nutrition, kidney and cardiac testing. The company also offers preclinical human and animal biomarker assay reagents and kits.

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

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

Kem-En-Tec Diagnostics Denmark • Taastrup Tel: (45) 3927-1771 Web: kem-en-tec.com E-mail: support@kem-en-tec.com Develops and produces superior, technology-enhanced components for colorimetricand chemiluminescent-based immunoassays. The company also provides environmentally friendly, ECO-TEC components for immunoassays, along with substrates, buffers and stabilizers for life science customers in 30+ countries.

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

Lab21 Healthcare UK • Cambridge Tel: (44) 1223-395-450 Web: lab21.com E-mail: info@lab21.com Provides molecular diagnostic products and services, along with a range of infectious disease assays, to healthcare organizations, clinical laboratories, and pharmaceutical companies.

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

Labline Equipments India • Gujarat Tel: (91) 265-263-2148 Web: lablineindia.com E-mail: mail@lablineindia.com Manufactures brushless centrifuges, needle destroyers, blood mixers, centrifuges, differential blood cell counters, vortex mixers, dry bath incubators, hematocrit digital centrifuges and roller mixers.

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

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LabMedica 300 LabONE

Labtest

Lampire Biological Laboratories

Landwind Medical China • Shenzhen Tel: (86) 755-8652-2242 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 Develops and produces in vitro diagnostic test systems for the clinical and research laboratory markets.

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

Leica Microsystems Germany • Wetzlar Tel: (49) 64-41-29-4099 Web: leica-microsystems.com Manufactures and supplies

USA • Skillman, NJ Tel: (1) 732-246-3366 Web: lifesignmed.com E-mail: info@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.

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

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

Linear Chemicals Spain • Barcelona Tel: (34) 934 694 990 Web: linear.es E-mail: info@linear.es Develops, manufactures and markets in vitro diagnostic (IVD) instruments and reagents, and accessories for clinical laboratory. The company exports all over the world: the brands Cromatest, Clonatest, PlusSed and LiNEAR are distributed in 125 countries.

Lobeck Medical 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.

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

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

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USA • Lawrenceville, GA Tel: (1) 770-270-1394 Web: lwscientific.com E-mail: info@lwscientific.com Supplies products to the laboratory market, including microscopes, centrifuges, and general lab equipment, for applications in hematology, pathology, cytology, and infectious diseases.

Maccura Biotechnology China • Chengdu Tel: (86) 028-8173-1888 Web: maccura.com E-mail: export@maccura.com Develops, produces, markets and distributes IVD products for applications in clinical biochemistry, chemiluminescent immunoassay, rapid diagnosis, thrombosis, hemostasis, and molecular diagnosis.

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

LifeSign

LW Scientific

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.

Web: maxcom.com.cn E-mail: info@maxcom.com.cn Designs diagnostic equipment such as automated hematology analyzers, as well as biochemistry analyzers.

Mast Group

Mayo Medical Laboratories

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.

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Brazil • Lagoa Santa Tel: (55) 31-3689-6900 Web: labtest.com.br E-mail: labtest@labtest.com.br Develops, manufactures, and commercializes IVD reagents and diagnostic equipment for the clinical chemistry industry.

optical solutions based on microscopes and related instruments

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Maxcom Electronic China • Shenzhen Tel: (86) 0755-2650-4439

USA • Rochester, MN Tel: (1) 507-266-5700 Web: mayomedical laboratories.com E-mail: mmlglobal@mayo.edu Offers 3,000+ tests and provides access to Mayo Clinic physicians and scientists. As part of the Mayo Clinic’s Department of Laboratory Medicine and Pathology, the company performs tests for Mayo Clinic patients and provides reference testing

for 4,000+ hospitals, clinics, and labs in more than 70 countries worldwide.

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

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

Medica Corporation USA • Bedford, MA Tel: (1) 781-275-4892 Web: medicacorp.com E-mail: rmorrill@medicacorp.com Manufactures simple-touse, highly reliable diagnostic blood testing analyzers, and also designs products to enhance productivity and

SEE AD ON PAGE 14

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

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 • Vantaa 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 • Paris 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) 12-0464-6916 Web: magnusoptics.com E-mail: sales@ magnusanalytics.com Manufactures microscopes and microscope optics for the clinical laboratory market.

Master Diagnostica Spain • Granada Tel: (34) 958-271-449 Web: masterdiagnostica.com E-mail: LINKXPRESS COM

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LabMedica 300 E-mail: medix@ medixbiochemica.com Develops, produces and markets monoclonal antibodies, antibody services and recombinant antigens for the IVD industry, as well as diagnostic rapid tests for human healthcare worldwide.

Medical Biological Union

Medsource Ozone Biomedicals

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 E-mail: diag@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.

India • Faridabad 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: export@mslabos.com Produces hematology cell counters and hematology reagents for the clinical lab.

Menarini, A., Diagnostics Italy • Florence Tel: (39) 55-56801 Web: menarinidiagnostics.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, microbi-

Meridian Bioscience USA • Cincinnati, OH Tel: (1) 513-271-3700 Web: magellandx.com E-mail: leadcaresales@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: info@ meridianlifescience.com Provides contract R&D, process development, and manufacturing of critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets.

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

MicrobioLogics USA • St. Cloud, MN Phone: (1) 320-253-1640 Web: microbiologics.com Email: info@microbiologics.com Produces lyophilized microorganisms for quality control in microbiology laboratories worldwide. The

company specializes in clinical, industrial, food quality, environmental and educational markets, and offers over 3,000 items in the product line with more than 500 different lyophilized microorganism strains.

Microlit India • Lucknow Tel: (91) 99-1862-5629 Web: microlit.com E-mail: info@microlit.com Manufactures and markets liquid handling products including micropipettes and pipette filling devices for a range of laboratory applications.

Millipore Sigma USA • Burlington, MA Tel: (1) 800-645-5476 Web: merckmillipore.com E-mail: service@emdgroup.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.

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. SEE AD ON PAGE 29

Monlab Spain • Barcelona Tel: (34) 93-433-58-60 Web: monlab.com E-mail:

pedidos@monlab.es Specializes in clinical laboratory services, and manufactures in vitro diagnostic products for clinical biochemistry and serology.

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

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

lyzers, analytical lab equipment, biotechnology equipment, and diagnostic imaging equipment.

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

National Reference Laboratory UAE • Abu Dhabi Tel: (971) 2-493-0555 Web: nrl.ae E-mail: customercare@nrl.ae In partnership with LabCorp, NRL offers a comprehensive menu of more than 4,700 tests, providing a complete solution for all clinical testing needs.

MPW Med. Instruments Poland • Warsaw Tel: (48) 22-610-50-14 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 highspeed, 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 ana-

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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Finland • Espoo Tel: (358) 9-547-680 Web: medixbiochemica.com

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ology, healthcare education, and home health care.

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Medix Biochemica

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the quality of care in smallto-medium-size labs. The EasyRA chemistry analyzer is a compact benchtop solution offering a wide range of tests. Blood gas and electrolyte analyzers are routinely used in labs globally where there is the need to lower health care costs.

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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 semiau-

Visit us at

MEDLAB

Stand Z3.A56

LINKXPRESS COM

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LabMedica 300 tomatic hematology analyzers. The product range includes economical 2 parameter analyzers to fully automated 22 parameter analyzers with a barcode reader and a 50-sample rack.

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

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

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

Nova Biomedical USA • Waltham, MA Tel: (1) 781-894-0800 Web: novabio.us 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.

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

NuAire USA • Plymouth, MN Tel: (1) 763-553-1270 Web: nuaire.com Manufactures biological safety cabinets, CO2 waterjacketed incubators, laminar air flow equipment, ultra-low temperature freezers, and complementary products and systems.

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

Oasis Diagnostics 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.

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 intolerance, autoimmune disease, and infectious disease.

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

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

Orgentec Diagnostika 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 Finland • Espoo Tel: (358) 10-309-3000 Web: oriondiagnostica.com Specializes in rapid and easy-to-use clinical diagnostic and hygiene-monitoring products.

Orphee Medical Switzerland • Geneva 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

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small and mid-sized laboratories, as well as physician offices.

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

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

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

Provides products that include clinical laboratory equipment and reagents, surgical equipment and blood analytic equipment, and X-ray video devices.

PHC Europe Netherlands • Etten Leur Tel: (31) 765-433-833 Web: phchd.com/eu/ biomedical.com E-mail: biomedical.nl@ eu.phchd.com Specializes in products for lab conservation, incubation, and sterilization, along with offering a range of Biocision CoolProducts.

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

Polymedco USA • Cortlandt Manor, NY Tel: (1) 914-739-5400 Web: polymedco.com E-mail: info@polymedco.com Provides instruments and reagents for clinical chem-

istry and hematology, as well as POC tests for FOBT, cholesterol, diabetes, and bladder cancer detection.

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

Preventis Germany • Bensheim Tel: (49) 6251-707-110 Web: preventis.com E-mail: info@preventis.com The company focuses on point-of-care diagnostics, preventive medicine and therapy monitoring. Tests can be evaluated quickly and quantitatively with a smartphone app, enabling effective practice management and possibilities for telemedicine solutions.

Prokan Electronics China • Shenzhen Tel: (86) 755-2674-7910-807 Web: procanmed.com E-mail: info@procanmed.com

Develops, manufactures, and services medical testing instruments, as well as offers a series of hematology analyzers.

ProteomeTech Korea • Seoul Tel: (82) 2-6968-5278 Web: proteometech.com E-mail: protia@proteometech.com Conducts research on protein translation and modification in the proteome level so that proteins that are directly related to diseases can be found to protect and detect diseases beforehand.

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

Qiagen 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.

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

Peripheral Visions USA • Black Diamond, WA Tel: (1) 253-735-3910 Web: peripheralvisions.com E-mail: info@peripheralvisions.com Provider and exporter of replacement parts and supplies for use on most major brands of clinical chemistry analyzers. For over 32 years, the company has been serving hospitals, labs, service groups, MOH’s, the analyzer and reagent manufacturing community, as well as others worldwide.

PerkinElmer USA • Waltham, MA Tel: (1) 203-925-4602 Web: 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) 25-5263-5350 Web: perlong-china.com E-mail: perlong@perlongchina.com

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LabMedica 300 Quantimetrix USA • Redondo Beach, CA Tel: (1) 310-536-0006 Web: quantimetrix.com E-mail: sales@quantimetrix.com Designs, develops and manufactures a specialized portfolio of quality control products and OEM services that improve the efficiency and reliability of laboratory testing and patient care.

Quidel

Quimica Clinica Aplicada

R-Biopharm

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

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 ADS ON PAGES 2, 15

Ratiolab Germany • Dreieich Tel: (49) 0-6103-30025-0 Web: ratiolab.com E-mail: info@ratiolab.com Produces easy-to-operate, reliable devices for medical and biochemical laboratories.

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

Reagena Finland • Toivala

RNA Medical USA • Devens, MA Tel: (1) 978-772-9070 Web: rnamedical.com E-mail: customerservice@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.

Robonik India India • Mumbai Tel: (91) 251-268-9000 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: sakura.eu E-mail: info@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.

USA • Framingham, MA Tel: (1) 877-740-2129 Web: sciex.com E-mail: servicesales@sciex.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.

Salimetrics

Scimedx

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

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

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

Sanquin Reagents

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: savyondiagnostics.com E-mail: info@ savyondiagnostics.com Develops, manufactures, and markets diagnostic kits for the detection of infectious diseases and genetic screening. LMI-01-19 146

USA • Dover, NJ Tel: (1) 973-879-3484 Web: scimedx.com E-mail: info@scimedx.com Specializes in immunofluorescence, rapid, and ELISA technologies for a wide variety of unique and routine autoimmune, parasitic and infectious diseases, as well as particle agglutination, column chromatography and fractionation and conjugation of sera.

SD Biosensor 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.

SFRI 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. SEE AD ON PAGE 51

Shenzhen New Industries Biomedical Engineering (SNIBE) China • Shenzhen Tel: (86) 755-8654-0750 Web: snibe.com E-mail: sales@snibe.com Specializes in clinical laboratory instruments and IVD reagents including the production of nano magnetic microbead products, automated CLIA systems, analyzers and matched reagent kits, and magnetic enzyme immunoassay analyzers and matched reagent kits. SEE ADS ON PAGES 19, 52

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

Sekisui Diagnostics USA • Lexington, MA Tel: (1) 781-652-7800 Web: sekisuidiagnostics.com E-mail: questions@sekisui-dx.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.

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

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

Siemens Healthineers Germany • Erlangen Tel: (49) 69-6682-6602 Web: siemens.com/diagnostics Offers a broad spectrum of immunoassay, chemistry, hematology, molecular, urinalysis, and blood gas testing systems, along with automation, informatics, and services that can serve the needs of labs of any size today and tomorrow.

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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.

Sarstedt

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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.

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

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Spain • Amposta 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.

RAL Técnica para el Laboratorio

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

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

and oximetry analyzers; transcutaneous blood gas monitors.

SEE AD ON PAGE 3

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

Skannex Norway • Oslo Tel: (47) 90-68-46-96 Web: skannex.com E-mail: post@skannex.com Develops, manufactures, and markets software for image recognition, capturing, and analysis of bioassays, within the field of clinical diagnostics.

SLR Research USA • Carlsbad, CA Tel: (1) 760-930-9496 Web: SLRresearch.com

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LabMedica 300 E-mail: admin@slrresearch.com Supplies a broad range of essential biological-based, bulk human disease-state and normal sera, specialty/esoteric antibodies, controls/calibrators and the IRB Clinical Specimen Repository.

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

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

Span Divergent India • Surat, Gujarat Tel: (91) 26-1266-3232 Web: span.in E-mail: contact@span.in Focuses on research, development, and manufacturing of in vitro diagnostic and POC products.

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

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

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

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

that address infectious diseases and congenital disorders.

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

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

Streck USA • Omaha, NE Tel: (1) 402-333-1982 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.

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

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: support@ sunquestinfo.com Focuses on laboratory information and solutions specifically designed for general laboratory, pathology, blood bank, microbiology, molecular, and other specialty areas in the clinical diagnostic field.

Super Brush USA • Springfield, MA Tel: (1) 413-543-1442 Web: superbrush.com

E-mail: sales@superbrush.com Specializes in the design, development and manufacturing of foam swabs and applicators. From medical applicators to cleanroomcompatible swabs, the advanced foam swabs are designed for precision cleaning of lab equipment and delicate surfaces, collecting samples, removing excess materials, applying lubricants, solvents, adhesives, topical antiseptics and a range of other solutions.

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

to life and health sciences. Products available include vertical and horizontal laminar flow benches, biosafety cabinets, lyophilizers, containment and sterile isolators, and ultrafreezers.

E-mail: hello@tecodiagnostics.com Teco Diagnostics manufactures a range of products including urine reagent strips, clinical chemistry reagents, rapid tests, serology latex kits, ELISA, instruments, and blood glucose devices.

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

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

Telstar Technologies 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

Thermo Fisher Scientific 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 • Bad Wildbad Tel: (49) 7081-177-0 Web: titertek-berthold.com E-mail: bio@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

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

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.

Visit us at: Stand Z5.A30

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

Tecan 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: tecodiagnostics.com

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LabMedica 300 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

Toyobo

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

USA • San Diego, CA Tel: (1) 858-546-0004 Web: www.trilinkbiotech.com E-mail: info@trilinkbiotech.com Manufactures custom oligonucleotides, modified nucle-

Tyson Bioresearch Taiwan • Zhunan 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 • Seongnam Tel: (82) 31-721-8003 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 Tel: (86) 773-2288-582 Web: urit.com E-mail: info@uritest.com 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:

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 point-of-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 18

Vicotex Switzerland • Pully Tel: (41) 21-728-4286 Web: vicotex.com E-mail: contact@vicotex.com Specializes in the production of hospital and laboratory equipment, including products for central sterilization. SEE AD ON PAGE 50

Vircell Spain • Granada Tel: (34) 958-44-12-64 Web: vircell.com E-mail: info@vircell.com Develops, manufactures and markets ready-to-use kits for the diagnosis of human infectious diseases. The company specializes in R&D and offers complete diagnostic solutions for techniques including CLIA Monotest, ELISA, IFA, DFA, rapid tests, PCR controls and other unique in-house developments.

Vitro Spain • Madrid Tel: (34) 91-382-16-20 Web: vitro.bio

E-mail: vitro@vitro.bio Specializes in products including reagents and intelligent analysis software for application in flow cytometry, FISH probes for detecting nonrandom chromosomal abnormalities, software applications for pathology and PCR kits for HPV and lymphomas.

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

W.H.P.M. USA • Irwindale, CA Tel: (1) 626-443-8480 Web: whpm.com E-mail: info@whpm.com Focuses on the research and development of onestep 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.

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

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

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

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

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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 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.

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

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

WLD-TEC Germany • Gottingen Tel: (49) 0-36081-68940 Web: wld-tec.com E-mail: sales@wldtec.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) 20-3229-6083 Web: wondfo.com.cn E-mail: sales@ 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 Produces purified enzymes, proteins, nucleic acids and related biochemicals for cell biology, biochemistry, protein and DNA/RNA applications. The company also produces collagenases, nucleases and other proteases and use-tested kits for

the isolation of primary cardiomyocytes, neurons and hepatocytes. Animal-origin FREE collagenases, RNases, DNases and proteases are available for stem cell and biopharmaceutical applications.

Yashraj Biotechnology India • Mumbai Tel: (91) 22-6216-6800 Web: yashraj.com E-mail: bharat@yashrajbio.com Focuses on R&D and processing of native and recombinant antigens and antibodies having diagnostic applications. The company supplies high-quality antigens and antibodies to the diagnostics industry, manufactures assays and controls and offers OEM services.

YD Diagnostics Korea • Yongin Tel: (82) 31-329-2000 Web: yd-diagnostics.com E-mail: admin@ yd-diagnostics.com Develops, manufactures, and distributes diagnostic products for liquid-based cytology, MDx, and urinalysis. Products available include processors, fully automated systems, rapid tests, strips, and chemistry reagents.

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

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TriLink BioTechnologies

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-of-care (POC) and the clinical laboratory. The test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases.

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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 manufacturing of therapeutic antibodies.

Trinity Biotech

vbmarket@vector-best.ru Focuses on the research, development, and manufacture of ELISA kits and clinical chemistry reagents for public health.

▲

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

oside triphosphates and CleanAmp PCR products for the diagnostic market.

SEE AD ON PAGE 6

Zer Hitech Israel • Beit Shemesh 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.

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.

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

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