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ANNUAL REVIEW 2020 Top 100 COVID -19 Diagnostics Milestones Of the Year

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Annual Review 2020

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Top 100 COVID-19 Diagnostics Milestones of the Year. . . . . . . . 5

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Companies in Alphabetical Order . . . . . . . . . . . . . . . . . . . . . . . 23 Companies by Country. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Although all material in this directory is compiled from sources believed reliable, Publisher cannot be held liable for any errors, omissions or inaccuracies. Inclusion in this directory, or lack of it, does not constitute any endorsement or expression of other opinion by Publisher with regard to companies, their products or services.

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LabMedica International December/2020-January/2021

LabMedica TOP 100 COVID -19 DIAGNOSTICS MILESTONES OF 2020

020, a year of unprecedented crisis defined by the COVID-19 pandemic and its immense healthcare challenges, is now behind us. Thanks to a remarkable in vitro diagnostics sector mobilization, a wide range of diagnostic tools were developed and introduced during the year to control the pandemic. With the introduction of a number of successful vaccines by year-end, mass scale vaccinations are now expected to further battle the pandemic in the course of 2021. Our 2020 Annual Review below focuses on the Top 100 COVID-19 Diagnostics Milestones that helped clinical laboratories worldwide cope with the health crisis and save as many lives as possible. For reference to our comprehensive coverage of COVID-19 diagnostics developments in the past year, the reader is invited to turn to previous issues of LabMedica or visit our website archives at www. labmedica.com.

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

this infection are urgently needed for confirming suspected cases, screening patients, and conducting virus surveillance. Randox Diagnostic Test Distinguishes Coronavirus from Other Respiratory Infections

multiple analytes from a single sample.

MARCH Microbiologics Introduces First SARS-CoV-2 RNA IVD CE Marked Control

andox Laboratories (Crumlin, UK; www. randox.com) has announced the release of a rapid diagnostic test for the COVID-19 strain of coronavirus. Randox has adapted its patented Biochip Array Technology (BAT) for diagnosis of coronavirus. BAT is an innovative multiplexing technology which is utilized within the cartridge aspect of an autoanalyzer platform. The Biochip allows for the simultaneous detection of

icrobiologics, Inc. (Saint Cloud, MN, USA; www.microbiologics.com) has prepared synthetic RNA to assist in the development of diagnostic assays and the evaluation of the performance of nucleic acid tests for determination of the presence of SARS-COV-2. The SARS-CoV-2 material is a 1044 nucleotide RNA specific for the SARSCoV-2 N (nucleocapsid) gene. It contains Cont’d on page 6

FEBRUARY CDC Provides Test Protocol for Novel Coronavirus

he US Centers for Disease Control and Prevention (Atlanta GA, USA; www.cdc.gov) has publicly posted its assay for novel coronavirus 2019-nCoV and is now developing the test into kits. The CDC diagnostic test is a reverse transcriptase real-time PCR (rRT-PCR) assay developed for respiratory and blood serum samples. The protocol specifies primers and probes, provides guidance on sample preparation, and advises performing rRT-PCR on the AB 7500 Fast DX thermal cycler (Thermo Fisher Scientific, Waltham, MA, USA; www. thermofisher.com). Two Rapid Tests for Diagnosis of the Novel Chinese Coronavirus

nvestigators at the University of Hong Kong (Hong Kong, China; www.hku.hk) have developed two rapid tests to enable clinicians to detect individuals infected with the potentially pandemic “Chinese” coronavirus. A novel coronavirus of zoonotic origin (2019-nCoV) has recently been identified in patients with acute respiratory disease. This virus is genetically similar to SARS coronavirus and bat SARS-like coronaviruses. The outbreak was initially detected in Wuhan, a major city of China, but has subsequently been detected in other provinces of China as well as in several other countries. Therefore, diagnostic tests specific for

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all three markers (N1, N2 and N3) detected by the CDC Real-Time RT PCR Panel for Detection of 2019 Novel Coronavirus. Israeli Researchers Introduce Pooling Method for COVID-19 Testing of Over 60 Patients Simultaneously

esearchers from Technion – Israel Institute of Technology (Haifa, Israel; www.tech nion.ac.il) and Rambam Health Care Campus (Haifa, Israel; www.rambam.org.il) have successfully tested a method, known as pooling, that enables simultaneous testing of dozens of samples and can dramatically increase the current COVID-19 testing capacity using existing available resources. Its implementation has the potential to greatly accelerate the rate of testing and detection of COVID-19 infected patients in the population. Abbott Launches New Test that Detects Coronavirus in Just Five Minutes

bbott (Lake Forest, IL, USA; www.abbott .com) has been issued EUA by the US FDA for the fastest available molecular pointof-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test runs on the company’s ID NOW rapid, instrument-based, isothermal system for the qualitative detection of infectious disease. The arrival of the Abbott ID NOW COVID-19 test followed the company’s launch of its Abbott m2000 RealTime SARSCoV-2 EUA test, which runs on the m2000 RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about five million tests per month. QIAGEN Receives US FDA EUA for First and Only Syndromic Coronavirus Test

IAGEN (Hilden, Germany; www.qiagen. com) has obtained EUA from the US FDA for its newly-developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from two other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.

APRIL Newly Coronavirus Blood Test Identifies Past Exposure

pair of new serological tests can detect novel coronavirus antibodies - evidence in persons tested that they have previously been infected by SARS-CoV-2, the viral cause of COVID-19 - even if they never experienced telltale symptoms. The tests, developed by clinical laboratory physicians and scientists at UC San Diego (La Jolla, CA, USA; www.ucsd.edu), build upon two assays developed by Diazyme Laborato-

Top 100 COVID-19 Diagnostics Milestones of the Year ries, Inc. (Poway, CA, USA; www.diazyme.com). World’s First Online Image-Based COVID-19 Diagnosis Improvement Tool Launched

etectED-X (Sydney, Australia; www.detecte dx.com), a University of Sydney spinoff comprising radiation and imaging experts, has launched the world’s only online image-based COVID-19 diagnosis improvement tool for healthcare workers. DetectED-X’s CovED platform, which can be accessed anywhere with an internet connection, is being provided for free and is supported by healthcare experts and leading corporations globally. New Coronavirus Test Works 10 Times Faster

new testing method for COVID-19 developed by researchers from the Hebrew University of Jerusalem (Jerusalem, Israel; www.en.huji.ac.il) can confirm the presence of the virus 4-10 times faster than the current method of extracting ribonucleic acid (RNA) molecules from a patient’s swab sample to see whether they contain viral RNA. In addition to being equally accurate, the new test does not use specially produced test kits or reagents needed for extracting RNA and instead uses materials commonly found in diagnostic labs, thus making it significantly cheaper and reducing dependence on imported testing materials. First Ever Multiplexed Serological SARS-CoV-2 Assay Released for Use in Surveillance Studies

uansys Biosciences (Logan, UT, USA; www. quansysbio.com) has released its SARSCoV-2 Human IgG(4- plex) enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of SARS-CoV-2 reactive IgG class antibodies in human serum and plasma. The company’s SARS-CoV-2 Human IgG(4-plex) is the first planar-based multiplex assay to allow simultaneous detection of human antibodies to the SARS-CoV-2 S1 protein, SARS-CoV-2 S2 protein, a negative control (Sheep Fc), and a positive control (anti-human IgG). The presence of the positive and negative control in each well allows the user to have confidence the assay was performed in accordance with the instructions for use (IFU). Rapid, Bluetooth-Connected Test Diagnoses COVID-19 in 60 Seconds

ememics Biotechnologies Inc. (Gaithersburg, MD, USA; www.hememics.com) is partnering with the Biomedical Advanced Research and Development Authority (BARDA) on the development of a rapid, BlueTooth-connected, easy-to-use test to diagnose COVID-19 in 60 seconds or less. The test detects SARSCoV-2 and associated antibodies from nasal swabs or whole blood, meeting a critical need to distinguish between individuals with active infections and those who have developed antibodies to the virus.

RT-LAMP Assay Developed for SARS-CoV-2

cientists at the Korea Research Institute of Chemical Technology (Daejeon, Korea; www.krict.re.kr) and their colleagues developed and evaluated RT-LAMP assays to detect genomic RNA of SARS-CoV-2. The team used SARS-CoV-2 viral RNA that was prepared as previously described. hCoV-229E and hCoVOC43 viral RNA were isolated from culture media of infected MRC-5 cells and MERS-CoV RNA was isolated from cell pellet lysate of infected Vero cells. The results of these highly specific RT-LAMP assays can be detected within 30 minutes after amplification reaction began. In addition, they provided optimized reaction conditions to which LCV colorimetric detection method is applied that can be used for point-of-care tests. Rapid Diagnostic Sensor Detects COVID-19 Directly from Swab Extracts

nvestigators at the Research Center for Bioconvergence Analysis at the Korea Basic Science Institute (Cheongju, Korea; www.kbsi.re.kr) have developed a diagnostic tool for the rapid detection of coronavirus from swab samples with no preparation steps. The team developed a rapid diagnostic sensor that detects the virus directly in a tube of buffer containing the swab samples, without any preparation steps.

MAY Sherlock CRISPR SARS-CoV-2 Kit Becomes First FDA-Authorized Use of CRISPR Technology for COVID-19

herlock Biosciences (Cambridge, MA, USA; www.sherlock.bio) has received Emergency Use Authorization from the US FDA for its Sherlock CRISPR SARS-CoV-2 kit for the detection of the virus that causes COVID-19, providing results in approximately one hour. The Sherlock CRISPR SARS-CoV-2 test kit is designed for use in CLIA-certified laboratories to perform high complexity tests. Quidel’s Sofia 2 SARS Antigen FIA Becomes First COVID-19 Antigen Test to Secure FDA Emergency Use Authorization

uidel Corporation’s (San Diego, CA, USA’ www.quidel.com) Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization by the US FDA. Quidel’s Sofia 2 SARS Antigen FIA is a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting CDC criteria for suspected COVID-19 infection. New One Minute Coronavirus Test Offers More than 90% Accuracy at Dramatically Lower Price

sraeli researchers have developed and are now validating a test that identifies carriers Cont’d on page 7

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of the COVID-19 virus in less than a minute with greater than 90% accuracy and at a dramatically lower price than any other method available. The test, developed by Ben-Gurion University of the Negev (BGU; Beer-Sheva, Israel; www.bgu.ac.il), uses a chip with a dense array of metamaterial sensors that was designed specifically for this purpose. World’s First SARS-CoV-2 Serology Test Detects Neutralizing Antibodies without Containment Facility or Specimen

esearchers have developed the world’s first serological coronavirus detection system that allows for rapid detection of neutralizing antibodies (NAbs) present in the serum of COVID-19 patients without the need for live biological materials and biocontainment facility. GenScript Biotech Corporation (Piscataway, NJ, USA; www. genscript.com), Duke-NUS Medical School, and the Diagnostics Development Hub (DxD) at Singapore’s Agency for Science, Technology and Research (A*STAR) have entered into an exclusive agreement to co-develop and manufacture the unique serological COVID-19 detection system known as the surrogate virus neutralization test (sVNT) or cPass.

but also shows the results through a relative numerical value in COI (Cut-Off Index), enabling the user to diagnose the levels of IgM and IgG antibodies present and manage their quantitative results more specifically.

JUNE

First True POC COVID-19 Antibody Tests Offer Convenience and Ease of Use

Researchers Develop Chip for Biomolecule Detection to Aid COVID-19 Testing

special sensor similar to a computer chip. The application-specific integrated circuit chip is designed for the early detection of a number of pathogens and viruses.

esearchers have developed a patented method for single biomolecule detection that overcomes limitations of current technologies and could help in the fight against COVID-19. Purdue University (West Lafayette, Ind., USA; www.purdue.edu) innovators have created a method that uses a

wo newly-launched rapid COVID-19 antibody tests are awaiting Emergency Use Authorization (EUA) approval from the US FDA and once authorized, would become the first true point-of-care (POC) tests designed for convenience and ease of use, allowing providers to triage their patients as efficiently as possible. Vivera Pharmaceuticals, Inc. (Newport Beach, CA, USA; www.viverapharmaceuticals.com) Cont’d on page 8

New COVID-19 Mouth Swab Test Can Be Completed On-Premises in 13-25 Minutes without Laboratory Involvement

eneMe (Gdansk, Poland; www.ge neme.eu) has developed FRANKD, a fast, scalable and reliable mouth swab test for COVID-19 that is completed on-premises in on average 13-25 minutes with no laboratory involvement. FRANKD requires less time to produce a result than the gold-standard RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) reference test recommended by the World Health Organization and uses a patented enzyme rather than the currently scarce reagents used in RT-PCR tests to rapidly produce a definitive and reliable result. DxGen Launches ‘2 Minutes’ COVID-19 Antibody Testing System

newly-launched ‘2 minutes’ detection system for COVID-19 IgM / IgG antibodies offers reliable testing with several attractive features for medical professionals and has also received CE Mark. The newly-developed Epithod 616 analyzer and COVID-19 IgM/IgG test kit from DxGen Corp. (South Korea; www. dxgen.vbweb.kr) is the fastest system that not only provides positive (+, ++, +++) or negative (–) results,

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has launched the POC ready rapid serology tests which are designed to serve where patients most critically require screening testing. One test is optimized for use in mass-screening settings, such as drive through testing centers, and the other test is more suitable for use in doctor’s offices and health clinics. World’s First Quantitative Surrogate Viral Neutralization Test Evaluates COVID-19 Protective Immunity in US

he world’s first quantitative surrogate Viral Neutralization Test (sVNT) to evaluate COVID-19 protective immunity in the US will measure and quantify the neutralizing capacity of antibodies against the SARS-CoV-2 virus. The test, marketed as Tru-Immune, is being offered by Ethos Laboratories (Newport, KY, USA; www.ethos-labs.com) in partnership with GenScript (Piscataway, NJ, USA; www.genscript.com). Unlike other tests currently on the market, Tru-Immune detects the presence and magnitude of neutralizing antibodies that prevent infectivity of the COVID-19 virus. New COVID-19 Test Pinpoints Human Antibodies Specific to Particular Part of SARS-CoV-2 Spike Protein

cientists at the University of North Carolina at Chapel Hill School of Medicine (Chapel Hill, NC, USA; www.unchealthcare. org) have developed a COVID-19 test that pinpoints human antibodies specific to a particular part of the SARS-CoV-2 spike protein. The new kind of antibody test is a simplified experimental assay that could be ramped up to test thousands of blood samples at labs that do not have the resources of commercial labs and large academic medical centers. Smartphone-Powered, Saliva-Based COVID-19 Diagnostic Test Delivers Lab-Quality Results to App in 20 Minutes

portable, saliva-based COVID-19 diagnostic test will be able to detect COVID-19 infection in less than 20 minutes, with an easy-to-use device that can be employed in a variety of settings. The COVID-19 diagnostic test called Atlas is being developed by Nicoya (Ontario, Canada; www.nicoyalife.com) and will be powered with smartphone technology so that it can deliver lab-quality results to an app in less than 20 minutes. The test will be performed with a saliva sample, rather than the more common nasopharyngeal swab samples. Randox Unveils Cytokine Testing for COVID-19 Risk Stratification and Treatment Monitoring

andox Laboratories (Crumlin, UK; www. randox.com) has unveiled cytokine testing for COVID-19 risk stratification and treatment monitoring. Cytokines play a vital role in the immune system and are known to be involved in the body’s response to a variety of

Top 100 COVID-19 Diagnostics Milestones of the Year inflammatory and infectious disease, such as COVID-19. Randox’s test, which looks for the presence of cytokines (a type of small protein) is performed on the company’s patented Biochip Technology, which can simultaneously detect multiple analytes from a single patient sample. World’s First High-Throughput, Multi-Antigen COVID-19 Biochip Test Launched

engenics (Singapore; www.sengenics.com), a functional proteomics company, has launched ImmuSAFE COVID+, the world’s first high-throughput, multi-antigen COVID-19 biochip test. A multi-antigen, multi-domain, fully quantitative serology test, ImmuSAFE enables the determination of the target epitopes, titres and Ig class/sub-class (IgG, IgA, IgM; IgG1-4) of antibodies produced across all stages of COVID-19 infection, from initial exposure, disease development, post-recovery or post-vaccination.

JULY Triple Antibody Test for COVID-19 Provides Laboratory-Standard Results in Just Seven Minutes

new triple antibody test detects antibodies to three different COVID-19 proteins in seven minutes at the PoC, giving a more powerful profile of the clinically relevant biomarkers than other currently available COVID-19 tests. The next-generation test developed by Attomarker Ltd. (Devon, UK; www.attomarker.com) uses a multiplex platform to simultaeously test for three virus proteins (Spike 1, Spike 2 & N) and three classes of antibodies (IgM, IgG and IgA), giving a more powerful profile of the patient’s immune response to COVID-19. First-in-Class COVID-19 Rapid Diagnostic Test for Neutralizing Antibodies Could Serve as Immunity Passport for Vaccine Developers

new rapid diagnostic test for measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells could serve as an ‘Immunity Passport’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. NeuCovix, a rapid 10-minute test unveiled by AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.aximbiotech.com), measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors, unlike the currently available serological COVID-19 tests that detect an antibody response to the virus. Quest Diagnostics’ SARS-CoV-2 rRT-PCR Test Becomes First COVID-19 Diagnostic Test to Receive FDA EUA for Sample Pooling

he US Food and Drug Administration has reissued an emergency use authorization (EUA) to Quest Diagnostics (Secaucus, NJ, USA;

www.questdiagnostics.com) to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples containing up to four individual swab specimens collected under observation. PerkinElmer Launches New Dried Blood Spot Based COVID-19 Serology Test

erkinElmer, Inc. (Waltham, MA; USA; www. perkinelmer.com) has launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP/DELFIA platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing. The product is being marketed as a CE-IVD test, and the company plans to apply for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA). First-of-its-Kind Rapid COVID-19 Test Detects Neutralizing Antibodies with 99-100% Specificity and 95-100% Sensitivity within an Hour

first-of-its-kind rapid COVID-19 test can detect neutralizing antibodies with high specificity and sensitivity within an hour and is capable of differentiating antibody responses from other known human coronaviruses. The unique and rapid SARS-CoV-2 surrogate virus neutralization test (sVNT) developed by the Duke-NUS Medical School (Singapore; www. duke-nus.edu.sg) could provide a much-needed boost to current COVID-19 investigations to determine infection rate, herd immunity, predicted humoral protection, and vaccine efficacy during clinical trials. Ultrasensitive Droplet Biosensing Method Dramatically Shortens Identification Time for COVID-19

cientists at Virginia Tech (Blacksburg, VA; www.vt.edu) have developed an ultrasensitive biosensing method that could dramatically shorten the amount of time required to verify the presence of the COVID-19 virus in a sample. In the method, all the contents of a sampling droplet can be detected, and there is no extraction or other tedious procedures.

AUGUST No-Touch, Paper-Based COVID-19 Diagnostic Test Could Detect SARSCoV-2 Using Electrical Frequencies

esearchers from the Iowa State University (Ames, IA, USA; www.iastate.edu) are developing a closed, contact-free diagnostic sensing system that could be used to quickly test for COVID-19 or other outbreaks. The researchers aim to develop a low-cost, mail-safe, fast-scan “diagnostic platform that is well-suited for widespread monitoring of infection during pandemics.

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New COVID-19 Mobile Testing Device Diagnoses Infection Immediately via Breath Sample Using AI

team of scientists from Technion – Israel Institute of Technology (Haifa, Israel; www. technion.ac.il) and Russell Berrie Nanotechnology Institute (Haifa, Israel; www.rbni.technion. ac.il), in collaboration with Chinese researchers, has devised a novel breathalyzer that uses that can rapidly detect COVID-19 from specific volatile organic compounds (VOCs) in exhaled breath. The novel breath analyzer test to rapidly detect the disease caused by the novel coronavirus has “the potential to serve as a monitoring and epidemic control tool.” US FDA Authorizes First Tests from Siemens That Estimate Antibodies from Past COVID-19 Infections

he US Food and Drug Administration has authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in an individual’s blood. Both tests from Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com), the ADVIA Centaur COV2G and Atellica COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

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Top 100 COVID-19 Diagnostics Milestones of the Year First FDA EUA COVID-19 Saliva Testing Kits Launched

he first FDA Emergency Use Authorization (EUA) COVID-19 saliva testing kits have been launched in the US by Accumen Inc. (Phoenix, AZ, USA; www.accumen.com) in partnership with Spectrum Solutions (Salt Lake City, UT, USA; www.spectrumsolution. com). This authorization mandated saliva collection solely using Spectrum’s SDNA-1000 saliva collection device based on a trial with Rutgers University. The Spectrum saliva collection kit has been engineered to produce more accurate and sensitive test results, reduce sample collection errors, including for at-home self-collection, reduce labor required for collection and reduce use of valuable PPE. Helix COVID-19 NGS Test One of the First Sequencing-Based COVID-19 Tests to Secure FDA Emergency Use Authorization

elix (San Mateo, CA, USA; www.helix. com) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test, making it one of the first sequencing-based COVID-19 tests to be granted FDA EUA. The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory speci-

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mens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider. Thermo Fisher Develops New COVID-19 Antibody Assay Targeting Transplant Community

hermo Fisher Scientific Inc.’s (Waltham, MA, USA; www.thermofisher.com) transplant diagnostic business has developed the LABScreen COVID Plus Assay which will be provided under the company’s One Lambda brand representing leading in vitro diagnostic products for the transplant community. The assay leverages the Luminex xMAP technology to detect multiple distinct antibodies and fragments, making it more specific than current assays and able to reduce false positives caused by infections with common coronavirus. Ground-Breaking One-Step COVID-19 Cartridge May Enable Large-Scale Antibody Testing

new one-step testing cartridge for COVID-19 antibody testing is being developed by Vivera Pharmaceuticals, Inc. (Newport Beach, CA, USA; www. viverapharmaceuticals.com) that will use a simplified procedure to eliminate operator error and deliver more consistent results. Cont’d on page 12

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Vivera is currently in discussions with top telemedicine providers in the US to develop effective testing protocols for the one-step cartridge once the FDA provides the appropriate pathways. AI Spectral Technology COVID-19 Detection Test Achieves 95% Success Rate in Clinical Trial

n AI spectral technology rapid COVID-19 detection test developed by Newsight Imaging Ltd. (Ness Ziona, Israel; www.nstimg. com) has shown promise in clinical trials by achieving a 95% success rate. The test developed includes a single cost-effective chip and uses an AI algorithm to separate the profile of a human infected with a specific virus, from a human infected with a different virus or from a healthy human.

Top 100 COVID-19 Diagnostics Milestones of the Year New 1-Step COVID-19 PCR Collection Buffer for Viral Detection Assays Reduces Cost and Time Required for SARS-CoV-2 Testing

novel PCR collection buffer from RayBiotech Inc. (Peachtree Corners, GA, USA; www.raybiotech.com) allows for immediate use of the saliva and other sample types on authorized tests, cutting out a significant amount of the required processing effort and time. The 1-Step COVID-19 PCR collection buffer can also be used directly in the assay without RNA purification from nasal and throat swabs. Ultra-High-Volume COVID-19 Test to Enable Genomic Diagnostic Testing and Population Screening for 40,000 Samples per Day

eracyte, Inc. (South San Francisco, CA, USA; www.veracyte.com) and MAVIDx,

Inc. (Miami, FL, USA; www.mavidx.com) have entered into an agreement for MAVIDx to develop ultra-high throughput genomic testing for SARS-CoV-2 on the nCounter Analysis System, Veracyte’s diagnostics platform. The novel approach using molecular barcodes for viral RNA to perform ultra-high throughput genomic testing for SARS-CoV-2 may enable processing of over 40,000 patient samples per day. Tests to Detect Common Immune Signature in Blood of COVID-19 Patients Could Predict Severity of Disease

esearchers at the Francis Crick Institute (London, UK; www.crick.ac.uk), King’s College London (London, UK; www.kcl.ac.uk) and Guy’s and St Thomas’ NHS Foundation Trust (London, UK; www.guysandstthomas. nhs.uk) have found a common immune signature in the blood of patients with COVID-19. The common immune signature could be used to predict how severely ill a patient will become, thereby aiding patient management. First-Ever Saliva-Based COVID and Influenza Combo Test to Screen for Coronavirus and Flu Infections

esearchers at Rutgers University’s (New Brunswick, NJ, USA; www. rutgers.edu) RUCDR Infinite Biologics are developing a potential coronavirus and influenza combo saliva-based test that would indicate if an individual has been infected by COVID-19, the flu, or neither, according to a report on NJ.com. The researchers hope to receive approval for the coronavirus and influenza combo saliva test by the fall in time for the flu season, marking a crucial development as both the viruses share similar characteristics and symptoms. Novel SERS Assay Could Identify Superspreaders Carrying Coronavirus Mutations

cientists from Rutgers University (New Brunswick, NJ, USA; www. rutgers.edu) have developed a new technique that can not only identify and quantify viral RNA in living cells, but also detect minor changes in RNA sequences that might give viruses an edge or make some people “superspreaders.” Based on the new technique, the scientists are now developing COVID-19 diagnostic tests to identify superspreaders, or people carrying unusually high amounts of the SARS-CoV-2 virus and infecting many others. Abbott’s USD 5, 15-Minute BinaxNOW COVID-19 Ag Card Becomes First Diagnostic Test with Read-Result Test Card to Receive FDA EUA

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Authorization (EUA) by the US Food and Drug Administration (FDA) for its BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19 infection. BinaxNOW is highly portable (about the size of a credit card), affordable at USD 5 and provides results in 15 minutes. The test uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider.

SEPTEMBER New Portable, 30-Minute COVID-19 Test Could Enable Diagnosis at POC without Need for Laboratory

esearchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA; www.illinois.edu) have demonstrated a prototype of a rapid COVID-19 molecular test and a simpleto-use, portable instrument for reading the results with a smartphone in 30 minutes, which could enable POC diagnosis without needing to send samples to a lab. The researchers are now exploring whether the assay would work with saliva samples to eliminate the need for nasopharyngeal swabs, and collecting more patient data as they consider next steps for regulatory approvals. Universal COVID-19 Antibody Test Could Identify Suitable Plasma Donors and Provide Critical Information on Coronavirus Immunity

esearchers from Houston Methodist (Houston, TX, USA; www.houstonmethodist.org) are significantly closer to developing a uniform, universal COVID-19 antibody test that could address the need for quick, easy tests to screen plasma donors. The researchers tested alternative ways to measure COVID-19 antibody levels that is faster and easier and can inexpensively be used on a larger scale to accurately identify potential donors with the best chance of helping patients infected with the SARS-CoV-2 virus with convalescent plasma therapy. New Promega XpressAmp Direct Amplification Reagents Allow COVID-19 Testing Labs to Skip RNA Extraction

Top 100 COVID-19 Diagnostics Milestones of the Year

been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The kit utilizes portable laboratory-grade diagnostic technology that can run up to 96 tests per device in just 30 minutes. It detects nucleic acids from the SARS-CoV-2 virus to determine positive or negative results and then utilizes the free MobileDetect App for Apple and Android platforms to generate result reports with time, date, images, patient info, GPS mapping and more. Groundbreaking RNA Extraction-Free qSanger-COVID-19 Assay Secures FDA EUA

groundbreaking SARS-CoV-2 diagnostic test from BillionToOne, Inc. (Palo Alto, CA, USA; www.billiontoone.com) that eliminates the costly and time-consuming step of RNA extraction has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). Unlike most other molecular assays that rely on RNA extraction and qRT-PCR, the qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2. New Ultra-Sensitive Super Antibody Test Could Identify COVID-19 Patients at Risk for Severe Illness

esearchers at the Harvard Medical School (Boston, MA, USA; www.hms.harvard.edu) and Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) have developed a test that could identify COVID-19 patients who are likely to need intensive care. Known as the Single Molecule Array (Simoa) SARS-CoV-2 antigen test, it is the first test that both detects and measures blood levels of S1- a protein that is part of the SARS-CoV-2 viral envelope. Self-Swab COVID-19 Collection Kit Receives FDA EUA for Use by CLIA-Certified Laboratories

aboratories testing for COVID-19 can now skip the potentially bottlenecked RNA extraction step of the workflow and move directly to polymerase chain reaction (PCR) amplification by using Promega Corporation’s (Madison, WI, USA; www.promega.com) new XpressAmp Direct Amplification Reagents which facilitate RNA extraction-free sample preparation that is automation-friendly.

he Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to a new COVID-19 self-collection kit from Color (Burlingame, CA, USA; www.color. com) that will enable public health and large private labs to increase access to testing. The FDA EUA allows labs at universities, states and public health organizations to use the self-swab kit for at-home or on-site COVID-19 testing and also enables CLIA-certified laboratories designated by Color to use its self-swab COVID-19 collection kit for public health.

COVID-19 Test Kit Using Portable Technology with Mobile App Result Reporting Secures FDA EUA

New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization

new groundbreaking MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit from DetectaChem (Sugar Land, TX, USA; www. detectachem.com) that uses portable technology along with mobile app result reporting has

new portable PCR COVID-19 test kit from Visby Medical (San Jose, CA, USA; www. visbymedical.com) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use in lab

environments. Visby, a Silicon Valley startup, has become the first company to be granted FDA EUA for a portable PCR COVID-19 test kit, which it has named Personal PCR. Menarini Diagnostics Launches New SARS-CoV-2 Antigen Test that Also Measures Viral Load

new COVID-19 test from A. Menarini Diagnostics (Florence, Italy; www.menarinidiagnostics.com) detects the presence of antigens can not only determine whether a patient is positive for COVID-19, as well as provides an indication of the viral load, allowing the most infectious and most at-risk patients to be identified immediately. These tests are unlike molecular biology tests because, although they also use nasopharyngeal swabs to take the sample, antigen tests do not search for the genetic material of the virus. Instead, they check for the presence of antigens and, therefore, for potential infection by searching for specific viral proteins. World’s First Patient-Controlled Nasopharyngeal Swab Robot for COVID-19 Testing Reduces Risk of Exposure to SARS-CoV-2

new robot developed by Biobot Surgical Pte Ltd (Singapore; www.biobotsurgical. com) for automated COVID-19 swab test could provide a solution to protect and reduce the risk of exposure faced by healthcare workers to the SARS-CoV-2 virus. SwabBot, a robot for automated swab, is designed to address the challenges of COVID-19 swab test. In addition to protecting and reducing the healthcare workers’ risk of exposure to the novel coronavirus, SwabBot also standardizes the consistency of swabs taken while providing greater throughput of swab tests. FDA Authorizes First Point-of-Care Antibody COVID-19 Test

he US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda. gov) has issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. The test was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. The EUA has now been reissued to authorize the test for POC use using fingerstick blood samples. FDA Authorizes First Nanopore Sequencing-Based Test for SARS-CoV-2

he US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to the Clear Dx SARS-CoV-2 novel descriptive diagnostic from Clear Labs (San Carlos, CA, USA; www.clearlabs.com), Cont’d on page 16 LabMedica International December/2020-January/2021

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making it the first nanopore sequencing-based test for SARS-CoV-2 to receive EUA. Clear Dx offers a fully automated, nanopore-based NGS solution for simultaneous high-volume diagnosis of SARS-CoV-2 and deeper genomic characterization of the virus. At a price comparable to qPCR, Clear Dx simultaneously improves test accuracy while providing end-to-end results in hours, instead of days. Cepheid Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV Granted FDA Emergency Use Authorization

epheid (Sunnyvale, CA, USA; www.cephe id.com) has been issued an emergency use authorization (EUA) by the US Food and Drug Administration for its four-in-one combination test for SARS-CoV-2, Flu A, Flu B and RSV. The Xpert Xpress SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The regulatory authorization will make the test available globally on its cartridge-based GeneXpert Systems, which features instruments that can be configured for both near patient point-of-care and high volume laboratory testing needs. Blood-Based Test That Accurately Identifies Viral Infection Before Symptoms Develop Could Help in Early Identification of SARS-CoV-2

team of scientists from the Duke University Health System (Durham, NC, USA; www.dukehealth.org) are conducting studies to determine the effectiveness of newly-identified biomarkers in detecting SARS-CoV-2. The biomarkers can accurately identify numerous viral infections across the clinical stages of disease, offering a potential new way to guide treatment, quarantine decisions, and other clinical and public health interventions in the setting of endemic and pandemic infectious diseases, such as COVID-19. FDA Grants First Ever EUA to COVID-19 POC Antibody Test for Use with Fingerstick Blood Samples

dial Pharmaceuticals, Inc. (Charlottesville, VA, USA; www.adialpharma.com) has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Assure/FaStep COVID-19 IgG/IgM Rapid Test Device. This is the FDA’s first ever EUA for a serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. Machine Learning-Based Rapid Diagnostic Reads Immune System to Predict COVID-19 Severity Risk

nflammatix (Burlingame, CA, USA; www.infla mmatix.com) has been awarded USD 1.1 million by the Defense Advanced Research

Top 100 COVID-19 Diagnostics Milestones of the Year Projects Agency (DARPA) for further development of a rapid diagnostic named CoVerity COVID-19 Severity Test. The rapid diagnostic reads the immune system to predict severe respiratory failure risk in COVID-19 patients and is being developed by Inflammatix to help physicians make better hospital admission and resourcing decisions for COVID-19 patients at hospital presentation.

OCTOBER New Diagnostic Tool Identifies and Treats COVID-19 Patients at Serious Risk of Developing Cytokine Storm

esearchers at Intermountain Healthcare (Salt Lake City, UT, USA; www.intermountain healthcare.org) have developed a new clinical tool to accurately identify and diagnose COVID-19 patients who are at high risk of developing a serious inflammatory condition that can damage the lungs and other organs. The new tool is a diagnostic clinical score that is used to determine whether patients with the virus are at increased risk of developing the condition, known as hyperinflammatory syndrome, also sometimes referred to as a “cytokine storm.” New, Portable Lab-on-a-Chip Identifies Concentration of COVID-19 Antibodies in Human Blood in 15 Minutes

esearchers from the University of Michigan (Ann Arbor, MI, USA; www.umich. edu) have developed a new, portable labon-a-chip that can identify the presence of COVID-19 antibodies in blood with greater speed and efficiency than the current standard “enzyme-linked immunosorbent assay” or ELISA technology. The researchers have demonstrated that the device can identify the concentration of COVID-19 antibodies in human blood in 15 minutes. That process normally takes between hours and a few days. New Sensor Rapidly Detects COVID-19 Infection Status, Severity, and Immunity

new type of multiplexed test (a test that combines multiple kinds of data) with a low-cost sensor could enable diagnosis of a COVID infection through rapid analysis of small volumes of saliva or blood, without the involvement of a medical professional, in less than 10 minutes. Researchers at the California Institute of Technology (Caltech Pasadena, CA, USA; www.caltech.edu) have developed wireless sensors that can monitor conditions such as gout, as well as stress levels, through the detection of extremely low levels of specific compounds in blood, saliva, or sweat. The new version of the sensor, which has been named SARS-CoV-2 RapidPlex, contains antibodies and proteins that allow it to detect the presence of the virus itself; antibodies created by the body to fight the virus; and chemical markers of inflammation, which indicate the severity

of the COVID-19 infection. New COVID-19 Testing Method Delivers Accurate Results without Using Reagents

team of scientists at the University of Vermont (Burlington, VT, USA; www. uvm.edu), working in partnership with a group at the University of Washington (Seattle, Wash., USA; www.washington. edu) has developed a newly-developed COVID-19 testing method that does not make use of key chemicals, or reagents, but still delivers accurate results. The method for the test omits the step in the widely used reverse transcription polymerase chain reaction (RT-PCR) test where the scarce reagents are needed. In their study, the new test correctly identified 92% of the positive samples and 100% of the negatives. The positive samples the new test failed to catch had very low levels of the virus. Automatic Point-of-Care System Measures COVID-19 Antibodies Along with HbA1c, CRP, U-Albumin within 3 Minutes

xGen Corp. (Korea; www.dxgen.vb web.kr) has launched the Epithod AutoDx analyzer, a new automatic point-of-care system that measures COVID-19 antibodies along with HbA1c, glycated albumin, hemoglobin, C-reactive protein and U-Albumin within just three minutes. By providing medical professionals with various and valuable diagnostic information, the Epithod system can be effectively used not only for COVID-19 diagnosis tests, but also for complication diagnosis tests and patient prognosis monitoring and treatment in various medical front lines. World’s First Assay Kit to Directly Profile SARS-CoV-2 Subgenomic RNA (sgRNA) from Clinical Samples Launched

ucence (Singapore; www.lucence.com), a molecular diagnostics company, has launched the world’s first assay kit to directly profile SARS-CoV-2 subgenomic RNA (sgRNA), a marker of active viral replication, from clinical samples. DeepMARK utilizes Lucence’s proprietary ultrasensitive next-generation sequencing (NGS) technology, AmpliMARK, to concurrently detect and analyze the genome and transcriptome of SARS-CoV-2. Pinpointing sources of unlinked SARS-CoV-2 cases supports rapid public health response. New Dipstick Technology Could Offer Faster, Cheaper and Mobile COVID-19 Diagnosis

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extract and analyze genetic material could be used for cheap, accurate and mobile COVID-19 testing, including at airports and remote testing centers. The technology allows genetic material to be extracted in as little as 30 seconds, with a full molecular diagnosis in 40 minutes. The process can be used to extract genetic material from most living organisms, including people, livestock, bacteria and viruses. New COVID-19 Test Uses Magnetic Beads to Detect SARS-CoV-2 Virus

highly sensitive COVID-19 test, developed by researchers at the Norwegian University of Science and Technology (NTNU Trondheim, Norway; www.ntnu.edu), relies on magnetic nanoparticles to extract viral RNA. A key aspect of this made-in-Norway COVID-19 test is a specific combination of polar solvents, buffers, salts and other chemicals that do not damage the viral RNA molecule itself.

COVID-19 antibodies. The scientists are pooling their knowledge to design a device that can detect whether a person has antibodies linked to SARS-CoV-2, the virus that causes COVID-19. Peel-and-Sniff Cards Could Make Smell Test Single Best Predictor of Being COVID-19 Positive

ith mounting scientific evidence that anosmia, or loss of smell, is one of the most specific symptoms of COVID-19 infection, sensory scientists at the Pennsylvania State University (University Park, PA, USA; www.psu. edu) are developing peel-and-sniff cards to supplement other testing and surveillance efforts. World’s First Paper-Based COVID-19 Test Could Be Game-Changer for Coronavirus Testing

esearchers at the CSIR-Institute of Genomics and Integrative Biology (IGIB New Del-

hi, India; www.igib.res.in) have developed the world’s first paper-based COVID-19 test that uses cutting-edge CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology for detection of genomic sequence of the novel coronavirus. The technology was conceived and developed under a sickle cell mission and utilizes an indigenously developed cutting-edge CRISPR-Cas9 technology to specifically recognize COVID-19 sequence in a sample. New COVID-19 Test Uses Nanotube-Based Electrochemical Biosensor for Rapid Detection of SARS-CoV-2 Virus in 30 Seconds

new COVID-19 rapid test developed by engineers and virologists at the University of Nevada (Reno, NV, USA; www.unr.edu) uses a nanotube-based electrochemical biosensor and has shown successful lab results Cont’d on page 18

30-Second COVID-19 Breathalyzer Test Could Be a Game-Changer

ndia and Israel are jointly developing a new rapid COVID-19 testing kit that will simply require an individual to blow into a tube and deliver results in less than a minute, making the test a real game-changer. The test would be extremely cheap to perform, as it would deliver results locally and eliminate logistics as well as the cost involved for sending samples to the laboratory. Holographic Imaging-Based COVID-19 Test Could Detect Both SARS-CoV-2 Infection and Antibodies in 30 Minutes

new method developed by scientists at New York University (New York, NY, USA; www.nyu.edu) to detect both viruses and antibodies uses holographic imaging and has the potential to aid in medical diagnoses and, specifically, those related to the COVID-19 pandemic. The scientists who have developed the new method base their test on holographic video microscopy, which uses laser beams to record holograms of their test beads. If fully realized, the proposed test could be done in under 30 minutes, is highly accurate, and can be performed by minimally trained personnel. Glucose Monitor for Measuring Blood Sugar Levels Reconfigured for Use as SARS-CoV-2 Antibody Detector

trio of scientists – a pharmacologist, a biomedical engineer, and a biophysicist – at the Johns Hopkins University (Baltimore, MD, USA; www. jhu.edu) has developed a system for using everyday glucose monitors to detect

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a subsidiary of Astrotech Corporation (Austin, TX, USA; www.astrotech.com), has signed a joint development agreement (JDA) with Cleveland Clinic (Cleveland, OH, USA; www.cleve landclinic.org) to explore leveraging Astrotech’s BreathTest-1000 mass spectrometer to rapidly screen for COVID-19 or related indicators.

New 1-Minute COVID-19 Antibody Test Uses Innovative Flow-Through Technology to Deliver Results

New Cell-Free Test Rapidly Detects COVID-19 Neutralizing Antibodies

by detecting the SARS-CoV-2 virus in about 30 seconds. The novel COVID-19 testing approach is based on a similar technology used in the past for detecting tuberculosis and colorectal cancer as well as detection of biomarkers for food safety.

new one-minute antibody test for COVID-19 launched by bioLytical Laboratories (Vancouver, BC, Canada; www.biolytical.com) in Europe is the only test of its kind to use innovative flowthrough technology to deliver results, making it far faster than other antibody tests currently available. The INSTI COVID-19 Antibody Test is a new one-minute test that detects total antibodies to SARS-CoV-2 and is the only one of its kind to use innovative flow-through technology to deliver results, making it far faster than other antibody tests currently available. World’s Simplest High-Throughput RT-PCR Test for COVID-19 Could Increase Testing Capacity by Millions per Week

ioGX Inc. (Birmingham, AL, USA; www.biogx. com) has applied for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for its extraction-free, direct sample addition RT-PCR test for the detection of SARS-CoV-2 viral RNA in suspected COVID-19 patients. The Xfree COVID-19 Direct RT-PCR test is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready format and has the potential to increase testing capacity by millions per week. ThermoGenesis’ Breakthrough Lateral Flow Immunoassay Test Reader to Help Track Antibody Response of COVID-19 Vaccine Recipients

new breakthrough lateral flow immunoassay test reader technology from ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA; www.thermogenesis.com) aims to facilitate the widespread use of inexpensive, mass-produced, FDA-authorized SARS-CoV-2 lateral flow immunoassay (LFIA) tests to distinguish seropositive members of populations of concern (individuals who already have SARSCoV-2 antibodies), who might be a lower priority for the earliest immunization. The ThermoGenesis Reader will enable the tracking of vaccine recipients’ antibody response over time, both to presumptively confirm immune status and to determine when booster immunizations may be required by individuals whose initial vaccine responses are waning. Mass Spectrometry-Based Device Uses Breath Samples to Rapidly Identify COVID-19 Strains

cientists are leveraging mass spectrometry technology to develop a rapid, non-invasive device that will use breath samples to identify COVID-19 strains. BreathTech Corporation,

r. Stephen Smith of Seattle Children’s Research Institute (Seattle, WA, USA; www. seattlechildrens.org) has developed a new way to quantify whether an individual has neutralizing antibodies that could prevent the SARS-CoV-2 virus from infecting cells using a method that is more broadly applicable than those currently available. The newly developed diagnostic could have a range of potential commercial applications from broad community testing to assessing vaccine responses and screening for convalescent plasmas that have particularly high levels of neutralizing antibodies as a potential treatment. Cutting Edge All-in-One Equipment Can Turn 600 Square Feet Room into COVID-19 Testing Lab

essel Medical (Greenville, SC, USA; www. vesselmedical.com) has introduced Lab in a Box which comprises cutting edge all-in-one equipment that can turn a 600 square feet room into a COVID-19 testing lab. Developed by scientists and technicians in partnership with Hamilton Company, Thermo Fisher, Grenova, and Premier Medical Laboratory Services, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. The turnkey equipment that includes everything needed for professional laboratory level diagnostic is expected to radically change the landscape of COVID-19 testing. New Groundbreaking COVID-19 Test to Identify SARS-CoV-2 Virus Particles in Exhaled Breath within Five Minutes

mec (Leuven, Belgium; www.imec-int.com) is developing a SARS-CoV-2 test to identify positive cases and confirm whether someone is contagious in less than five minutes using a groundbreaking approach that will use virus particles in exhaled breath. The company has begun developing the groundbreaking SARSCoV-2 test that will identify the virus particles in a person’s exhaled breath, unlike the current approaches (using blood, saliva, or a nasopharyngeal swab). The solution promises accurate identification of a contagious case in less than five minutes, enabling faster, easier, more comfortable, and larger-scale testing. World’s Fastest PCR-Based SARS-CoV-2 Test Now Available on Randox-Bosch Vivalytic POC Analyzer

rapid new coronavirus test, which provides results for COVID-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Labo-

ratories (Crumlin, UK; www.randox.com) and Bosch Healthcare (Waiblingen, Germany; www. bosch-healthcare.com). The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centers at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.

NOVEMBER New Technology Pulls Elusive COVID-19 Marker from Blood to Better Measure Disease Severity

cMaster University (Hamilton, ON, Canada; www.mcmaster.ca) in collaboration with SQI Diagnostics, Inc. (Toronto, ON, Canada; www.sqidiagnostics.com) has created a new technology that can detect an elusive protein bio-marker from human blood to measure the severity of COVID-19. The researchers have created a surface that repels every other element of human blood except critical cytokine biomarkers like Interleukin-6 (IL-6), enabling timely and clear detection of critical “cytokine storm” progress of COVID-19 in individual patients. New COVID-19 Test That Identifies T-Cell Signature Better at Detecting Past Coronavirus Infection

sing a set of identified “shared” T-cell receptors (TCRs) that are seen across multiple individuals infected with COVID-19, Adaptive Biotechnologies (Seattle, WA, USA; www.adaptivebiotech.com) has identified a T-cell signature that can be used for diagnostic purposes. The company is developing a T-cell based diagnostic test that can that detect virus-specific T cells in a more effective way to assess SARS-CoV-2 exposure before antibodies arise and after they wane. COVID-19 Test Uses DNA Nanoswitch Technology to Detect SARS-CoV-2 Virus

n easy diagnostic test for COVID-19 based on DNA nanoswitch technology developed by scientists from the Program in Cellular and Molecular Medicine (PCMM) at Boston Children’s Hospital (Boston, MA, USA; www. childrenshospital.org) could offer a new way of detecting SARS-CoV-2, the virus causing the disease. The scientists aim to develop a test that is as easy as a pee stick, but as sophisticated and accurate as a laboratory system. The rapid test they are developing will not only detect the presence of COVID-19 antibodies, but also provide more information about those antibodies. Highly Automated Microlab Half the Size of Credit Card Detects COVID-19 in 30 Minutes

y leveraging the so-called “lab on a chip” technology and the cutting-edge genetic editing technique known as CRISPR, scientists at Stanford Medicine (Stanford, CA, USA; Cont’d on page 20 LabMedica International December/2020-January/2021

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www.med.stanford.edu) have created a highly automated device that can identify the presence of the novel coronavirus in just a half-hour. The microlab is a microfluidic chip just half the size of a credit card containing a complex network of channels smaller than the width of a human hair. The team created the device on a shoestring budget of just about USD 5,000. FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

he US Food and Drug Administration has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The FDA has issued an emergency use authorization (EUA) to GenScript USA Inc. (Piscataway, NJ, USA; www.genscript.com) for its cPass SARSCoV-2 Neutralization Antibody Detection Kit, which specifically detects antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. Siemens Becomes First Leading Diagnostics Company to Offer Quantitative COVID-19 Test for Measuring Neutralizing Antibodies

iemens Healthineers’ (Erlangen, Germany; www. siemens-healthineers.com) SARS-CoV-2 IgG Antibody Test (sCOVG) has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the US. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient’s blood sample. FDA Authorizes First COVID-19 Test for Self-Testing at Home

he US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. (Emeryville, CA, USA; www.lucirahealth.com) for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results. First Hybridization Capture-Based NGS Assay for Characterization and Surveillance of SARS-CoV-2 Launched

wist Bioscience Corporation (San Francisco, CA, USA; www.twistbioscience.com) and Biotia, Inc. (New York, NY, USA; www.biotia. io) have developed the SARS-CoV-2 NGS Assay, an NGS-based assay for research-use only (RUO). The SARS-CoV-2 NGS RUO Assay is a highly sensitive nucleic acid hybridization capture-based

Top 100 COVID-19 Diagnostics Milestones of the Year assay used for the detection, characterization, and environmental monitoring of the SARSCoV-2 virus. It utilizes Twist Bioscience’s unique ability to rapidly develop virus-specific panels by DNA synthesis and Biotia’s comprehensive data analysis software and reporting capabilities. FDA Grants EUA to One of the First Tests That Measures Specific Levels of COVID-19 Neutralizing Antibodies

he US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first tests that measures specific levels of COVID-19 neutralizing antibodies. COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit from Kantaro Biosciences, LLC (New York, NY, USA; www. kantarobio.com), a joint venture between the Mount Sinai Health System (New York, NY, USA; www.mountsinai.org) and Renalytix AI (New York, NY, USA; www.renalytixai.com), has been granted EUA by the FDA. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Self-Swab Kit for COVID-19 Test Granted Emergency Use Authorization by FDA

kit developed by researchers at Stanford Medicine (Stanford, CA, USA; www.med. stanford.edu) that allows individuals to collect their own nasal swabs and ship the specimens to a lab for COVID-19 testing has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). With the kit, individuals can self-collect a sample using a safe and gentle nasal swab in the front their nostrils, providing organizations with a cost-effective approach to testing individuals swiftly, reliably and securely for COVID-19.

DECEMBER Fastest Ever Robotics-Driven COVID-19 Mass Testing Platform Gives 99% Accurate Results

new robotics-driven COVID-19 mass testing platform rolled out by Salient Bio (London, UK; www.salient.bio) is up to three times faster than competitors for mass testing and aims to provide affordable, effective and easy-to-access pre-emptive diagnostic solutions for a range of medical conditions that facilitate early intervention and improve overall health outcomes. The robotics-driven COVID-19 mass testing platform facilitates COVID-secure environments at a quicker and more cost effective rate than the closest approved competitor, with a same day results notification process and a very cost effective per unit price for businesses conducting mass testing. Printable POC SARS-CoV-2 Antibody Test for COVID-19 Could Produce Results in Real Time

low-cost electrochemical technology for multiplexed biomarker detection licensed

by the Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; www.wyss.harvard.edu) to The iQ Group Global (Sydney, Australia; www.theiqgroupglobal.com) could facilitate global serological testing for SARS-CoV-2 infections, and help trace immunity in individuals over time. This could lead to the creation of a chewing-gum-sized diagnostic ‘strip’ that can be used for COVID-19 testing at point of care, with the ability to be printed at scale at a low cost, and produce real-time results. The iQ Group Global will integrate Wyss’ eRapid technology with its biosensor platform, leading to the development of a chewing-gum-sized diagnostic ‘strip’ that can be used for COVID-19 testing at point of care, with the ability to be printed at scale at a low cost, and produce real-time results. New Silicon-Based Lab-on-Chip Test Could Pave the Way for Cheap Handheld COVID-19 Testing

tiny new silicon-based lab-on-chip test developed at the Imperial College London (London, UK; www.imperial.ac.uk) could pave the way for cheap COVID-19 testing. The chip known as TriSilix is a ‘micro laboratory’ which performs a miniature version of the polymerase chain reaction (PCR) on the spot. The system could in future be mounted onto handheld blood sugar test-style devices, allowing people to test themselves and receive results at home for colds, flu, recurrent infections like those of the urinary tract (UTIs), and COVID-19. New ELISA-Based COVID-19 Test Detects and Ranks SARS-CoV-2 Neutralizing Antibodies by Their Potency

new enzyme-linked immunosorbent assay (ELISA)-based COVID-19 diagnostic test by AXIM Biotechnologies, Inc. (San Diego, CA, USA; www.aximbiotech.com) detects and ranks SARS-CoV-2 neutralizing antibodies by their potency in a simple and relatively short test time. The test developed internally by AXIM aims to fulfill the need to know the levels of neutralizing antibodies in longitudinal studies of vaccine response in the post-vaccine COVID-19 fight. New CRISPR-Based COVID-19 Test Uses Smartphone Camera to Provide Accurate Results in 30 Minutes

cientists at Gladstone Institutes (San Francisco, CA, USA; www.gladstone.org), University of California, Berkeley (Berkeley, CA, USA; www.berkeley.edu), and University of California, San Francisco (UCSF; San Francisco, CA, USA; www.ucsf.edu) have developed a CRISPR-based test for COVID-19 that can detect the presence of SARS-CoV-2 in a nasal swab using a smartphone camera and provide accurate results in less than 30 minutes. Not only can their new diagnostic test generate a positive or negative result, it also measures the viral load (or the concentration of SARS-CoV-2, the virus that causes Cont’d on page 21 LabMedica International December/2020-January/2021

Annual Review 2020

Top 100 COVID-19 Diagnostics Milestones of the Year Cont’d from page 20

COVID-19) in a given sample. FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-Collected Samples

he US Food and Drug Administration (FDA) has authorized Quest Diagnostics’ (Secaucus, NJ, USA; www.questdiagnostics.com) RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. This is the first diagnostic test to be authorized by the FDA for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). High-Speed NanoPCR Technology Diagnoses COVID-19 in 20 Minutes with Zero False Positive and False Negative

uses “lab at your fingertip” technology to accurately measure the presence of SARS-CoV-2 antibodies in 15 minutes with no buffers, reagents, or additional equipment. The ADEXUSDx COVID-19 antibody test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies and delivers lab-quality results in 15 minutes with no buffers, reagents, or additional equipment. EKF Launches One of the First Tests to Precisely Measure Levels of COVID-19 Neutralizing Antibodies

KF Diagnostics (Cardiff, Wales, UK; www. ekfdiagnostics.com) has introduced the new Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit which is one of the first tests to precisely measure levels of COVID-19 neutralizing antibodies in individuals. The best-in-class serologic COVID-19 assay is based on technology

developed by clinicians at the Icahn School of Medicine at Mount Sinai Health System in New York in partnership with RenalytixAI, a spinout company from EKF Diagnostics. Thermo Fisher’s New Direct from Saliva PCR Test for COVID-19 Enables Fast, Low-Cost Results

hermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofisher.com) has launched a new direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. By performing the test directly from raw saliva and eliminating the need for equipment, materials, time and labor associated with nucleic acid extraction, the TaqCheck SARS-CoV-2 Fast PCR Assay helps labs meet the turnaround time of 24-48 hours recommended by the Centers for Disease Control and Prevention (CDC).

new high-speed nanoPCR technology for point-of-care (POC) diagnosis of COVID-19 developed by scientists at the Center for Nanomedicine (CNM) within the Institute for Basic Science (IBS; Seoul, Korea; www.ibs.re.kr) can accurately diagnose the infection in less than 20 minutes, with zero false positive and false negative. The nanoPCR technology can diagnose COVID-19 while retaining the accuracy of conventional reverse transcription polymerase chain reaction (RT-PCR) technology. Ultra-Specific, Non-Invasive Saliva Test Enables Quantitative Testing Of COVID-19 Antibodies

home-collection assay developed by Liquid Diagnostics (San Clemente, CA, USA; www.liquid-dx.com) for the quantitative testing of COVID-19 antibodies using saliva now makes it possible for individuals to monitor the level of their COVID-19 antibodies over time without leaving home. The quantitative COVID-19 antibody test is the first home-collection, ultra-specific, non-invasive saliva test. The test is perfect for monitoring both epidemiologic and vaccine response studies because of its unparalleled specificity of this assay and because individuals can collect samples with an easy-to-use mouth swab at home and mail the sample to a centralized laboratory. COVID-19 Test Uses “Lab at Your Fingertip” Technology to Measure SARS-CoV-2 Antibodies in 15 Minutes

new rapid serology, self-contained assay from NOWDiagnostics, Inc. (Springdale, AR, USA; www.now.com)

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Annual Review 2020 Cont’d from page 21

Novel Rapid Lateral Flow Immunoassay Can Function as “Suitcase Laboratory” for On-Site Detection of COVID-19

cientists from the Suzhou Institute of Biomedical Engineering and Technology (Suzhou, China; www.sibet.ac.cn) have developed a novel amplification-free rapid SARS-CoV-2 nucleic acid detection platform based on hybrid capture fluorescence immunoassay (HC-FIA) to fulfill the need for rapid and accurate nucleic acid detection at the point of care. The use of the monoclonal antibody S9.6 is the distinctive feature of this process developed by scientists. The process recognizes DNA-RNA double-stranded hybrids and enables the conversion of nucleic acid testing into immunofluorescence on a simple lateral flow dipstick. The whole test procedure involves two steps, namely hybridization and immunofluorescence analysis, and it can be finished in less than an hour.

Top 100 COVID-19 Diagnostics Milestones of the Year POC Reader Automatically Analyzes COVID-19 Test Strips and Transmits Results Electronically

attaCo (Murrieta CA, USA; www.gattaco. com) and iAssay (San Diego, CA, USA; www.iassay.net) have entered into a partnership to integrate and optimize their products in an effort to provide enhanced rapid serology testing, including COVID-19 antibody testing and electronic test result transmission to federal and state agencies via the cloud at the point of care. GattaCo has developed and patented rapid and automatic plasma separation tools, called the A-PON and pediatric-focused miniPON Kits. The plasma generated by the PON Kits can transform anormaly Yes or No antibody test to a semi-quantitative test and enable more sensitive quantitative detection by the iAssay CyberReader device, reducing false positives and negatives. FDA Develops Fecal Test for COVID-19

he US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda.gov) has

developed a test for COVID-19 in fecal matter that aims to prevent the disease from being inadvertently transmitted during fecal transplantation. There is no validated stool test as of now, although the FDA has developed a “working assay for detection” of the coronavirus responsible for COVID-19 in stool. Smartphone-Read Ultrasensitive and Quantitative Saliva Test for COVID-19 Provides Results within 15 Minutes

portable saliva-based smartphone platform offers an ultrasensitive yet accessible approach to COVID-19 testing by providing results within 15 minutes without the resource-intensive laboratory tests the current gold standard requires. In a new study that tested the approach in 12 people infected with COVID-19 and six healthy controls, the researchers demonstrated that this technique, which pairs a fluorescence microscope readout device with a smartphone to determine viral load from a CRISPR/Cas12a assay, works as effectively as the well-established quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) method. NE DES W IGN

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ALPHABETICAL LISTING OF COMPANIES 77 Elektronika

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

AADEE

Abaxis

USA • Union City, CA Tel: (1) 510-675-6500 Web: abaxis.com E-mail: abaxis@abaxis. com Produces point-of-care blood analyzers for both humans and animals. The analyzers are designed to be portable, require minimal training, provide 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.

Abbott Diagnostics

USA • Abbott Park, IL Tel: (1) 224-667-6100 Web: abbott.com Provides in vitro diagnostics, instrument systems, and tests. Products offer diagnostic solutions in immunochemistry, 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 transfer lab-based assays to lateral flow assays.

AccuBio Tech

China • Beijing Tel: (86) 10-8048-4980 Web: accubiotech.com E-mail:

Accumax Lab Technology

India • Gandhinagar 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.

Acon Laboratories

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.

Adaltis

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

Adam Equipment

UK • Milton Keynes 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.

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.

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.

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 “AADEE-ZEN” ISE that has the capability to measure Na, K, Cl, and Ca.

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.

WORLD’S IN VITRO DIAGNOSTICS COMPANIES

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Agappe Diagnostics Switzerland

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

Agro-Bio A Stago Company

France • La Ferté Saint-Aubin Tel: (33) 238-648-350 Web: agro-bio.com Specializes in biotechnologi-

cal solutions and high quality products for immunotechnology, protein biochemistry, and platelet aggregation to serve the research projects and the needs of the academic and industrial sectors.

AirClean Systems

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.

Alfa Scientific Designs

USA • Poway, CA Tel: (1) 858-513-3888 Web: alfascientific.com E-mail: sales@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.

Alifax

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

Alpha Laboratories

UK • Eastleigh, 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.

Aferrix

Israel • Ashdod Tel: (972) 52-5989926 Web: aferrix.com E-mail: info@aferrix.com Develops, manufactures, and markets fluorescence-based kits for the diagnosis and monitoring of iron overload. The company also provides testing services for pharmaceutical companies and research centers worldwide.

Affinity Biologicals

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

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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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

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

AMS Alliance

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: analyticon-diagnostics. com E-mail: info@ analyticon-diagnostics. 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.

Apacor

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

Apel

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.

Apex Biotechnology

Taiwan • Hsinchu Tel: (886) 3-564-1952 Web: apexbio.com E-mail: info@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

Arkray, Inc.

Japan • Kyoto Tel: (81) 75-662-8979 Web: arkray.co.jp Focuses on the production of diabetes testing devices, urinalysis systems, gene analysis devices and other equipment. Established as a leader in the blood glucose monitoring market with over 50 years of experience of innovation in clinical diagnostics.

Artel

USA • Westbrook, ME Tel: (1) 207-854-0867 Web: artel-usa.com E-mail: info@artel-usa.com Focuses on improving proLINKXPRESS COM

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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) 818-880-6700 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.

Astech

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

Astell Scientific

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

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.

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

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.

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.

Awareness Technology

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

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: salesdept@belart.com Manufactures and distributes over 3,500 items from safety wash bottles to fume hoods, distributed under well known brand names such as Scienceware, PLUM, Sterileware, Magic Touch, Secador and H-B Instrument.

Benchmark Scientific

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

Berthold Technologies

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

AXIOM Solutions

Germany • Bürstadt Tel: (49) 6206-6012 Web: axiom-solutions.de E-mail: info@axiom-solu tions.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 E-mail: info@bbisolutions.com Supplies diagnostic and therapeutic reagents and conjugates, gold and silver labeling of proteins and oligonucleotides, as well as quality control sera for molecular diagnostic tests.

BD Diagnostics

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

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.

USA • Allentown, PA Tel: (1) 484-223-0309 Web: aristabiologicals.com E-mail: info@aristabiologicals.com Manufactures and supplies rapid diagnostic reagents, components and related equipment for membrane-based assays.

cess productivity and quality by providing easy-to-use systems for validating liquid delivery performance.

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Bio-Rad Laboratories

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

BioAssay Works

USA • Ijamsville, MD Tel: (1) 301-874-8888 Web: bioassayworks.com E-mail: sales@bioassayworks.com Offers gold sol nanoparticles (10 to 50 OD), gold con-

LabMedica International December/2020-January/2021

LabMedica 300 jugates, 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

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.

Biolabo

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

Biomat

Italy • Santa Margherita di Ala Tel: (39) 0464-357951 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.

Biomedical Polymers

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.

BioMerieux

France • Marcy l'Etoile Tel: (33) 4-7887-2000

BioPerfectus

China • Shanghai Tel: (86) 021-64193032 Web: www.bioperfectus. com E-mail: info@bioperfectus. com Focuses on molecular diagnostic solutions for infectious diseases. The company manufactures products ranging from real time PCR kits, nucleic acid extraction systems, rapid tests and automation laboratory devices, etc.

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

Web: biomerieux.com Designs, develops, manufactures and markets in vitro diagnostics systems used in clinical and industrial applications.

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BioPorto Diagnostics

Denmark • Hellerup Tel: (45) 4529-0000 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.

BIORON Diagnostics

Germany • Speyer Tel: (49) 6232-29844-0 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.

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.

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.es E-mail: biosystems@ biosystems.es Develops and manufactures reagents and instruments for clinical analysis.

Biotech Company Nanchang

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: bt@biotecnica.it Designs and manufactures standard and OEM clinical chemistry equipment and relevant reagent products intended for private and state clinical laboratories including photometers, automatic analyzers, and ion selective analyzers.

Biotron Diagnostics

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

Block Scientific USA • Bellport, NY Tel: (1) 631-589-1118

Web: blockscientific.com E-mail: info@blockscientific.com Provides reconditioned laboratory equipment as an alternative to purchasing new. Areas of specialty include blood gas, electrolyte, chemistry and hematology, with products such as consumables, parts, reagents, and technical service also available.

Blue Cross Bio-Medical

China • Beijing Tel: (86) 10-6975-6015 Web: bcbmo.com E-mail: bluecross@bcbmo.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 supplies in-vitro diagnostic assays, including automated solutions and rapid tests.

BPC BioSed

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

analyzers and relative reagents worldwide.

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: callegari1930.com E-mail: info@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.

Biosynex

Francia • Strasbourg Tel: (33) 3-88-78-7887 Web: www.biosynex.com E-mail: client.pro @biosynex.com Develops, manufactures, and markets medical devices for screening, diagnosis and prevention, specializing in the design and distribution of rapid diagnostic tests (RDT).

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.

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Canterbury Scientific

New Zealand • Christchurch Tel: (64) 3-343-3345 Web: canterburyscientific.com E-mail: info@ canterburyscientific.com Manufactures freezedried and ready-to-use liquid quality hemoglobin controls for hematology and biochemistry diagnostic tests. Products are used for monitoring blood tests and calibrating equipment and processors on in vitro diagnostic analyzers.

Capp

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

CareHealth America

USA • Blue Earth, MN Tel: (1) 507-526-3951 Web: drugcheck.com E-mail: marketing @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.

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.

LabMedica 300 Carewell Biotech

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

Carl Zeiss MicroImaging

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

Carolina Liquid Chemistries

USA • 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) 1-805-28-49 Web: carperlabs.com. co E-mail: ventas@ carperlabs.co Manufactures and merchandizes reagents for in vitro diagnositcs for use in clinical laboratories and blood banks.

CDG Biotech Corp

USA • Westlake Village, CA Tel: (1) 805 2220877 Web: cdgbiotech.com E-mail: info@cdgbiotech. com IVD-manufacturer based in California, focused on novel-clinical diagnostics for labs and physicians to meet patient care needs. Produces innovative solutions using leading-edge automation in exclusive design that help labs reduce critical labor costs while improving response time and the quality of results.

CellaVision

Sweden • Lund Tel: (46) 46-460-1600 Web: cellavision.com E-mail: info@ cellavision.com Develops systems for the routine analysis of blood and other fluids, which provide critical results used in the diagnosis of a variety of diseases such as infection and cancer.

Cellasys

Germany • Kronburg Tel: (49) 83-94-257929 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: cepheid @cepheideurope.fr 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.

Chembio Diagnostic Systems

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: chemclin@ chemclin.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.

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

Copan Diagnostics

USA • Murrieta, CA Tel: (1) 951-696-6957 Web: copanusa.com 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: sales@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@cpcdiag nostics.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: sales@crony.it Markets and sells automatic and semi-automatic analyzers, and develops and produces analyzers on an OEM basis.

CTK Biotech

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

Cytocell

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

Cytognos

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

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) 20-3206-8126 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 • Palombara Sabina Tel: (39) 0774-637070 Web: dasitaly.com E-mail: info@dasitaly.com Designs and manufactures analyzers and automated equipment. Main fields of application are immunoen-

zymatic, immunofluorescence, and clinical chemistry.

Delcon

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

Denka Seiken

Japan • Tokyo Tel: (81) 3-6214-3236 Web: www.denka.co.jp E-mail: info@denka-seik en.com 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.

DFI

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

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

Diagast

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

DiagCor Life Science Limited

China • Hong Kong Tel: (852) 2147-4088 Web: diagcorlifescience. com E-mail: sales@diagcorlife science.com Specializes in flow-through hybridization technology for

molecular diagnostics. The company operates in the areas of infectious disease identification, oncology, and genetic testing, offering a wide range of in vitro diagnostic (IVD) systems, instruments, and test kits for DNA, RNA and protein rapid analysis.

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: www. diagnosticuminc.eu E-mail: mail@ diagnosticum.hu Develops and markets biochemistry reagents and immunology kits, with applications for open analyzers.

Diagnostica Stago

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

Diagon

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

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.

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: info @diamonddiagnostics.com Specializes in refurbished e-”quipment for chemistry, immunology, hematology, coagulation, microbiology, flow cytometry, and blood gases. The company also

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LabMedica 300 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

DiaSorin

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

DIAsource ImmunoAssays

Belgium • Louvain-La-Neuve 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.

DiaSys Diagnostic Systems

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 13

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

Diestro

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

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.

Develops, manufactures, and markets a wide range of centrifuges for use in medical, research, educational, and industrial laboratories.

DWK Life Sciences

Germany • Mainz Tel: 49 (0) 6131-1445 4131 Web: www.dwk.com E-mail: sales@ sales@dwk.com DWK Life Sciences brings together three leading manufacturers of precision glassware, laboratory consumables and specialty products for life sciences, in the globally recognized brands DURAN, WHEATON and KIMBLE. Offers customers a complete, comprehensive line of purpose-built glassware, plastics, and fused-material-based containers for research, diagnostics, and specialty pharmaceuticals markets.

DxGen

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.

tures innovative ELISA instruments, including the Agility automated system with SmartKit technology. As a leader in automated microplate technology, the company offers the new Multiplier with SmartPLEX technology.

Dymind Biotech

EastCoast Bio

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.

Dynex Technologies

USA • Chantilly, VA Tel: (1) 703-631-7800 Web: dynex.com E-mail: customerservice@ dynextechnologies.com Designs and manufac-

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

E-mail: salesoffice@ diesse.it Products include: Erythrocyte sedimentation rate test; modular instrument for bacteriological screening and isolation of microorganisms in urine and stool; complete line of Elisa test kits, which offer common reagents; multiparametric analyzer for infectious diseases and autoimmunity; agglutination tests for CRP, RF, ASO, Febrile Antiges and complement fixation tests for manual procedure.

SEE AD ON PAGE 15

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.

EKF Diagnostics

UK • Cardiff Tel: (44) 29-20-710570 Web: ekfdiagnostics.com E-mail: info@

DRG International

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

DNA Genotek

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

Drucker Diagnostics

USA • Port Matilda, PA Tel: (1) 814-692-7661 Web: druckerdiagnostics. com E-mail: sales@ druckerdiagnostics.com

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ekfdiagnostics.com Manufactures point-of-care diagnostics and central laboratory assays with hemoglobin, hematocrit, HbA1c, glucose and lactate analyzers in regular use across more than 100 countries. Specializes in developing tests for use in diabetes and anemia diagnosis and management, as well as providing a portfolio of reagents for use in clinical chemistry analyzers.

ELGA LabWater

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

ELITech Group

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

LabMedica 300 E-mail: info@elitechgroup.com Offers a range of products for in vitro diagnostics in clinical chemistry, hemostasis, microbiology, immunology, and electrophoresis.

SEE AD ON PAGE 10

Emperor Electronic Technology

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.

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.

SEE AD ON PAGE 5

Eppendorf

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

Esco Micro

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

France • Les Ulis Tel: (33) 01-69 79 64 80 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.

Eurofins Technologies

Hungary • Budapest Tel: (36) 22-501-684 Web: www.eurofins-technologies.com E-mail: technologies.contact@eurofins.com Provides fast, reliable, and easy to use diagnostic test kits and instruments in the fields of bioanalytical testing for the food, feed, environmental, biopharma, and clinical industries. In clinical diagnostics segment, the company offers automated platforms and a broad test menu of diagnostic tests in the fields of virology, bacteriology, parasitology, mycology, tumor markers, hormones and autoimmune diseases.

Feather Safety Razor

Japan • Osaka Tel: (81) 6-6458-1638 Web: feather.co.jp E-mail: overseas@feather.co.jp Manufactures razor blades with technology and development capabilities centering on ultra-precision metal processing. Manufactures medical products for surgery, dermatology, ophthalmology and other areas, including products such as micro surgical blades, scalpels, ophthalmic knives, blade scissors and more. SEE AD ON PAGE 17

Fluid Metering

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

Fluorogenics

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

Fortress Diagnostics 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-theart instruments, software and automation systems.

Singapur • Singapur 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.

Eurobio

E-mail: office@eurotrol.com Provides QC materials to the diagnostic laboratory market, EQA/PT programs, standardization bodies, hospital labs, and POC.

Erba Diagnostics Mannheim

Toplabs catalog, which includes quality products such as TopStar glucose solution, ZeroDNA and Mycoplasmafree.

SEE AD ON PAGE 35

Eurospital

Italy • Trieste Tel: (39) 040 8997 1 Web: eurospital.com E-mail: info@eurospital.it 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

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 Long March Medical Science

China • Shanghai Tel: (86) 21-6076-5888 Web: en.lm-diagnostics. com.cn 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 Focuses on the field of IVD testing with more than 50 years’ experience in the conception, development, production and worldwide commercialization of robust IVD products, spanning the range from specialized testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states.

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

GeneReach Biotechnology

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

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: info@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.

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

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: en.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 E-mail: info@ chinagongdong.com Manufactures and distributes disposable medical and lab consumables.

Green Cross Medis

Korea • Cheonan Tel: (82) 41-551-0600 Web: gcmedis.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 E-mail: info@ greiner-diagnostic.com Specializes in developing, manufacturing and marketing a range of clinical diagnostic assays and kits including niche products like oxalate test, and pyruvate kinase deficiency test.

Grifols International

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

Haier Biomedical

China • Qingdao Tel: (86) 532-889-35593 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.

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.

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.

HEALES

China • Shenzhen Tel: (86) 0755 25821365 Web: heales.cn E-mail: sales@heales.cn Dedicated to the research, development, sale and service of clinical diagnosis products, which include liquid handling systems, microplate washers and readers, specific protein analysis systems, full automatic CRP analyzers and reagents.

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.

LabMedica International December/2020-January/2021

LabMedica 300 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 vor der Rhön Tel: (49) 9779-808-0 Web: assistent.eu E-mail: info@assistent.eu Offers products for blood tests and urine analysis, microscopic and staining utensils, liquid handling, water treatment, measuring glass instruments, as well as general lab apparatus, and hydrometers and thermometers.

HEMCO

USA • Independence, MO Tel: (1) 816-796-2900 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

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

Horron XLH Medical

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

HTL

Poland • Warsaw Tel: (48) 22-492-19-00 Web: htl.com.pl E-mail: htlcs@corning.com Specializes in the production of laboratory and medical products including single-channel variable-volume pipettes, multichannel pi-

pettes, fixed-volume pipettes, electronic pipetting controllers, and manual dispensers.

Human Diagnostics

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.

Humasis

Korea • Anyang Tel: (82) 31-8085-6200 Web: humasis.com E-mail: question @humasis.com Specializes in rapid testing, focusing on one field of Point-ofCare Testing (POCT), developing new technologies that can accurately and quickly analyze the causes of diseases in humans using biotechnology.

Hycor Biomedical

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.

HyTest

iCubio Biomedical Technology

USA • Garden Grove, CA Tel: (49) 0561 8167000-0 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. Finland • Turku Tel: (358) 2 512 0900 Web: hytest.fi E-mail: hytest@hytest.fi Offers innovative solutions for assay development and research applications by providing high-quality immunological reagents for cardiac markers, Troponin I and Troponin T, infectious disease antibodies, and autoimmune disease reagents.

IBL-America

USA • Minneapolis, MN Tel: (1) 763-780-2955

Sweden • Angelholm Tel: (46) 77-570-02-10 Web: hemocue.com E-mail: info@hemocue.se Develops, produces, and markets products for point-of-care testing. The company’s leading products measure hemoglobin and glucose in whole blood and albumin in urine.

Hemosure

USA • Irwindale, CA Tel: (1) 626-443-8480 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.

Hologic

USA • Marlborough, MA Tel: (1) 508-263-2900 Web: hologic.com E-mail: salessupport@ hologic.com Specializes in products for molecular diagnostics including Aptima assays and advanced automation platforms that allow labs to quickly and accurately detect or monitor infectious diseases. The company’s proven solutions are designed to help promote early detection, appropriate treatment, and better outcomes.

Hongqi Optical Instrument Technology

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

Horiba Medical France • Montpellier

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

Immucor

USA • Norcross, GA Tel: (1) 714-933-3222 Web: immucor.com E-mail: info@immucor.com Develops and manufactures

LabMedica 300 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.

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.

Immuno Concepts

USA • Sacramento, CA Tel: (1) 916-363-2649 Web: immunoconcepts. com Produces diagnostic test kits for autoimmune diseases including slide assays, ELISA assays, and a protein colorimetric microarray containing 10 DNA/ENA antigens.

Imutest

UK • Wilmslow Tel: (44) 7831-487263 Web: www.imutest.com E-mail: enquiries@imutest. com Produces point-of-care and self-test kits for the most common allergies which are developed and manufactured in the UK. Recent additions include rapid test kits for SARS-CoV-2 antigen and antibodies.

Immunodiagnostic Systems

UK • Boldon, Tyne and Wear Tel: (44) 191-519-0660 Web: idsplc.com E-mail: salessupport.uk@ idsplc.com Specializes in immunoassays and creates tools

IMMUNDIAGNOSTIK Germany • Bensheim Tel: (49) 6251 701 900

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

INCYTO

Korea • Cheonan Tel: (82) 41-415-2363 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.

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Integrated BioSystems

China • Beijing Tel: (86) 010-87227486 Web: ibs-bj.com E-mail: marketing@ibs-bj. com Specializes in the research and development, production, application, and technical services of advanced life science, medical diagnosis technology and equipment.

Inova Diagnostics

USA • San Diego, CA Tel: (1) 858-586-9900 Web: inovadx.com E-mail: service @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) 781-861-0710 Web: instrumentation laboratory.com E-mail: customerservice@ 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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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

Australia • Melbourne Tel: (61) 3 9192 6000 Web: invetechgroup.com 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: info@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.

JEOL

Japan • Tokyo Tel: (81) 42 5422303 Web: jeol.co.jp Focuses on the production of scientific and metrology instruments such as electron microscopes, ion beam instruments, mass spectrometers and NMR spectrometers. Committed to the development and research, manufacturing, maintenance and service of medical equipment, industrial equipment and other scientific instruments.

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.

Kementec

Denmark • Taastrup Tel: (1) 517-372-9200 Web: kementec.com E-mail: support@kementec.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,

LabMedica International December/2020-January/2021

LabMedica 300 buffers and stabilizers for life science customers in 30+ countries.

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 • Vadodara 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.

Labtest

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.

LabTurbo Biotech

Taiwan • Taipei City Tel: (886) 2-2889-1136 Web: labturbo.com.tw E-mail: info@labturbo.com.tw Specializes in the automation of DNA and RNA applications, focusing on the technologies and innovations for sample-to-result DNA/ RNA testing systems, fully automated DNA/ RNA extraction systems, qPCR testing kits (for COVID-19), extraction kits, and 96-well and 384-well liquid-handling systems.

Lampire Biological Laboratories

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.

Landwind Medical

China • Shenzhen Tel: (86) 755-8652-2242 Web: landwindmedical.com E-mail: jessica.hu @landwind.com.cn 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.

LabMedica International December/2020-January/2021

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 optical solutions based on microscopes and related instruments

LifeSign

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: en.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 • Roseto degli Abruzzi Tel: (39) 085-893-0745 Web: liofilchem.com 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 compa-

ny exports all over the world: the brands Cromatest, Clonatest, Plus-Sed and LiNEAR are distributed in 125 countries.

Lituo Biotechnolgy

China • Zhuhai Tel: (86) 756-8639521 Web: www.lituo.com.cn Specializes in R&D, manufacture and marketing of high-quality in-vitro diagnostic reagents and instrument. The company’s portfolio covers six series including microbiological diagnosis, vaginitis detection, stool routine examination, blood culture and immunoassay. Now offers a whole series of COVID antigen test, COVID antibody test, Virus transport media, etc.

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.

LabMedica 300 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.

LW Scientific

Maccura Biotechnology

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.

Magnasense Technologies

Finland • Vantaa Tel: (358) 40-5435-989 Web: magnasense.com E-mail: sales@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.

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.

Mast Group

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

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.

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.

SEE AD ON PAGE 28

Maxcom Electronic

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

as biochemistry analyzers.

Mayo Medical Laboratories

USA • Rochester, MN Tel: (1) 855-516-8404 Web: mayocliniclabs.com E-mail: mclglobal@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.

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.

Magna BioSciences

SEE AD ON PAGE 33

MDS Nordion

Canada • Ottawa, ON Tel: (1) 613-592-3400 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: sales @medicacorp.com Manufactures simple-to-use diagnostic blood testing analyzers. The company specifically designs products to enhance productivity and the quality of care in small to medium-size in vitro diagnostic laboratories.

Medical Biological Union

Russia • Novosibirsk Tel: (7) 383-363-7720 Web: mbunion.com E-mail: info@mbunion.com

Manufactures and markets ELISA products for IVD of infectious diseases, along with performance sera panels for the quality control of kits imported and manufactured in Russia.

Web: menarinidiagnostics. com Focuses on the research and development of diagnostic drugs that target cardiovascular diseases, oncology, and pain/inflammation, asthma.

Medical Wire & Equipment

Meridian Bioscience

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: medicon@mediconsa.com Specializes in the R&D, production and export of diagnostic reagents, the production of laboratory information software, and the import and distribution of in vitro diagnostics and automated analytical systems.

Medix Biochemica

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

Medsource Ozone Biomedicals India • 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.

MedTest Dx

USA • Canton, MI Tel: (1) 734-487-8300 Web: medtestdx.com E-mail: orders@medtestdx. 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.

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 LINKXPRESS COM

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

Meridian Life Science

USA • Memphis, TN Tel: (1) 901-382-8716 Web: meridianlifescience. com E-mail: 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

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.

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.

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 (single-channel and four-channel); hematocrit capillary-based bilirubinometer for neonates; and dry bath incubators.

MP Biomedicals

MicrobioLogics

MPW Med. Instruments

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: emdmillipore.com E-mail: emdinfo@ emdchemicals.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.

USA • Solon, OH Tel: (1) 440-337-1200 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.

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 high-speed, refrigerated or refrigerated and heated.

MYCO Instrumentation

USA • Bonney Lake, WA Tel: (1) 253-750-0818 Web: myco-instrumentation.com E-Mail: info@ myco-instrumentation.com Provides clinical laboratory equipment, clinical chemistry analyzers, hematology analyzers, coagulation analyzers, analytical lab equipment, biotechnology equipment, and diagnostic imaging equipment.

NanoEntek

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

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LabMedica 300 Neogen

USA • Lansing, MI Tel: (44) 161-820-3833 Web: lifesciences.neogen. com E-mail: inform@ neogen.com Specializes in the development and production of microbiological diagnostic products, including dehydrated culture media and chromogenic media.

NG Biotech

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Nihon Kohden

Japan • Tokyo Tel: (81) 3-5996-8036 Web: nihonkohden.com Major product line for clinical diagnostics includes both automatic and semiautomatic hematology analyzers. The product range includes economical 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 develop-

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.

NovaTec Immundiagnostica

Germany • Dietzenbach Tel: (49) 6074-4876-0 Web: novatec-id.com E-mail: info@novatec-id.com Mainly engaged in the development and manufacturing of ELISA diagnostic kits for both human and veterinary markets, focusing on infectious diseases (bacterial, viral and parasitic diseases). The product range of NovaTec includes ELISA and Real-time PCR kits.

NuAire

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

Nüve

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

Oasis Diagnostics

USA • Vancouver, WA Tel: (1) 360-546-1563 Web: 4saliva.com E-mail: info@4saliva.com Manufactures technologies for standardized collection and testing of saliva specimens. These include four technologies for COVID-19, devices for consumer genetics, cancer, hormones, Alzheimer’s disease and population specific devices for children, animals, infants, adults and geriatrics.

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 E-mail: customercare@ 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.

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

Ortho-Clinical Diagnostics

USA • Raritan, NJ Tel: (1) 800-828-6316 Web: orthoclinical.com E-mail: servicesales@ orthoclinicaldiagnostics. com Focuses on diagnostic products for donor screening, immunohematology, clinical chemistry, and immunodiagnostics.

OVVI Diagnostics

Belgium • Liège Tel: (33) 4 72 17 50 62 Web: www.ovvidx.com E-mail: contact@ovvidx. com Develops and markets magnetic immunoassays intended to improve rapid diagnostic performance for human and animal diagnostics.

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: marienfeld-superior. com E-mail: info@ marienfeld-superior.com Offers a comprehensive range of laboratory glassware including microscope slides, cover glass, counting chambers, capillary tubes, lab containers, and volumetric glassware.

Pentapharm

Switzerland • Aesch BL Tel: (41) 61 7064848 Web: pentapharm.com E-mail: pentapharm@ 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@perlong-china. com 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.

Polymedco

USA • Cortlandt Manor, NY Tel: (1) 914-739-5400 Web: polymedco.com E-mail: info@polymedco.

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

Porex

USA • Fairburn, GA Tel: (1) 770-964-1421 Web: porex.com E-mail: info.porex.emea@ filtrationgroup.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: shop@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)-755-26955166 Web: www.prokanmed. com E-mail: info@prokanmed. 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 Specializes in sample and assay technologies used to isolate and process DNA, RNA, and proteins from biological samples such as

blood or tissue.

Quantimetrix

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

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.

ment and manufacturing of specialty coagulation assays.

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Quidel

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.

Quimica Clinica Aplicada

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.

R-Biopharm

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

Radiometer Medical

Denmark • 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 and oximetry analyzers; transcutaneous blood gas monitors.

RAL Técnica para el Laboratorio

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

Randox Laboratories

UK • Crumlin, County Antrim Tel: (44) 0-28-9442-2413

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Web: randox.com E-mail: marketing@randox.com Develops diagnostic products including biochemistry, immunoassay & molecular analyzers in addition to first and third-party reagents. The comprehensive Randox Quality Control package comprises third party controls, inter-laboratory data management and large global EQA scheme.

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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.

Reagena

Finland • Toivala 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-touse test kits for POC and lab medicine.

RNA Medical

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

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,

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.

Salimetrics

USA • State College, PA Tel: (1) 814-234-2617 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.

Sanquin Reagents

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

Sarstedt

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

Savyon Diagnostics

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

LabMedica International December/2020-January/2021

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

Scimedx

USA • Dover, NJ Tel: (1) 973-625-8822 Web: scimedx.com E-mail: support@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.

Sentinel Diagnostics

LabMedica 300

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 • Limerick Tel: (353) 61-358-190 Web: serosep.com E-mail: info@serosep.com Distributes a range of laboratory diagnostic products for clinical and environmental labs. SEE AD ON PAGE 35

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 instru-

ments and reagents, specializing in human biological analysis and concentrating on routine clinical testing in the hematology, biochemistry, and immunology sectors.

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.

Siemens Healthineers

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.

Singuway Biotech

China • Shenzhen Tel: (86) 0755-23704711 Web: singuway.com E-mail: sales@singuway.com Develops molecular diagnostic systems, focusing on isothermal amplification and PCR. Products are applicable to biomedical, food sanitation, environment monitoring and other fields. Produces a new nucleotide isothermal amplification analyzer capable for testing for virus, infectious disease, microorganism, tumor DNA, antibiotic-resistance DNA, and food safety.

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.

SA Scientific

Sciex

Rayto Life and Analytical Sciences

instruments, reagents, and tests.

Germany • Erlangen Tel: (49) 69-6682-6602 Web: siemens-healthineers.com

China • Nanjing Tel: (86) 025-8412-7188

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.

Seegene

Koreea • Seoul Tel: (82) 2-2240-4000 Web: www.seegene.com E-mail: info@seegene. com Specializes in developing multiplex molecular technologies and multiplex clinical molecular diagnostics, offering a wide range of solutions applicable in diverse markets from clinical diagnostics to basic science research.

Sekisui Diagnostics

USA • Burlington, 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.

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Sinnowa

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LabMedica 300

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.

SLR Research

Socorex

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

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.

USA • Omaha, NE Tel: (1) 402-333-1982 Web: streck.com E-mail: international@streck. com Develops products to ensure accurate diagnosis for a path to healing and recovery. An ISO-certified biotech company that develops and manufactures quality control and diagnostic products in hematology, immunology, molecular diagnostics, infectious diseases and urinalysis for clinical and research laboratories.

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) 431-8465-0333 Web: sunostik.com E-mail: sales@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: info@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 cleanroom-compatible 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 E-mail: IVDtechsupport@ surmodics.com Develops reagents and applications for the biomedical research and diagnostic markets. The company provides high-sensitivity substrate chemistries and various diagnostic

Svar Life Science

Sysmex

Germany • Norderstedt Tel: (49) 40-527-260 Web: sysmex-europe.com E-mail: info@sysmex-europe.com Distributes and supports automated in vitro diagnostic hematology, coagulation and urinalysis analyzers, reagents, and information systems for laboratories and healthcare facilities.

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.

Technopath Clinical Diagnostics

Ireland • Ballina, Co. Tipperary Tel: (353) 61 525700 Web: www.technopathclinical diagnostics.com E-mail: info@techno pathcd.com Dedicated to the development and manufacturing of total quality control (QC) solutions for clinical laboratories. The company’s QC and software products are used by leading laboratories throughout the globe.

Teco Diagnostics

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

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

Spain • Terrassa Tel: (34) 937-361-600 Web: telstar.com E-mail: sales.laboratory@ telstar.com Designs and manufactures laboratory equipment for R&D, quality control, and analysis in

Theradiag

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

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 • Pforzheim 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) 312 397 0173 Web: tokra.com.tr E-mail: tokra@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) 3-6841-8300 Web: tokyo-boeki.co.jp Develops and markets a multifunction, small-sized automatic biochemical analyzer that is capable of processing 240 tests an hour.

Tosoh Bioscience

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

Toyobo

Japan • Osaka Tel: (81) 6-6348-3888 Web: www.toyobo-global.com Manufactures biopharmaceuticals using genetically engineered animal cells, specializing in cell culture technology, usable protein refinement and genetic and cell engineering. Currently, the com-

pany is focusing on genome drug discovery support and contract manufacturing of therapeutic antibodies.

TriLink BioTechnologies

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

Trinity Biotech

Ireland • Bray 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.

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 2288586 Web: urit.com E-mail: export@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: vbmarket@vector-best.ru Focuses on the research, development, and manufacture of ELISA kits and clinical chemistry reagents for public health.

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-ofcare (POC) testing. The company supplies fertility, infectious disease, drugs of abuse, tumor marker, cardiac marker and specializes in syphilis, tuberculosis, malaria and hepatitis tests.

Germany • Birkenfeld Tel: (49) 7082-7916-0 Web: stratec.com E-mail: instrumentation@ stratec.com Develops and manufactures re-

Streck

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

SEE AD ON PAGE 23

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 26

Vircell

Spain • Granada Tel: (34) 958-44-12-64 Web: vircell.com E-mail: info@vircell.com Develops and manufactures complete diagnostic solutions for human infectious diseases offering a wide range of serology test (VirClia® Monotest, ELISA, IFA, etc) and molecular biology solutions (Realtime PCR kits and AmpliRun® PCR Controls), together with other unique in-house developments.

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.

applications involving high-sensitivity chromogen substrates (colored chemical markers).

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

agents and kits for DNA/RNA stabilization, extraction, and purification using manual and automated systems.

SEE AD ON PAGE 37

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: sales@whpm.com Focuses on the research and development of one-step rapid membrane tests. Also, with sister company W.H.P.M. Bioresearch Technology Co., Ltd., W.H.P.M. has researched, developed, and produced rapid test systems that include current product Hemosure.

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 chro-

LabMedica International December/2020-January/2021

Companies by Country matography (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-toend capillaries, plastic heparinized blood gas capillaries and syringes, and capillary blood collection systems.

West Medica

Austria • Wiener Neudorf Tel: 43 (0) 2236 892465 Web: westmedica.com E-mail: vienna@westmedica.com Designs equipment for laboratory research and microscopy.

Wiener Laboratorios

Argentina • Rosario Tel: (54) 341-432-9191 Web: wiener-lab.com.ar E-mail: marketing@ 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@ wld-tec.com Specializes in stationary and mobile safety laboratory gas burners, as well as electrical sterilization systems, and a wide range of available accessories.

Wondfo Biotech

China • Guangzhou Tel: (86) 20-3229-6083 Web: en.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: worthington-biochem.com E-mail: international@

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.

Xunda

China • Shanghai Tel: (86) 21-57687666 Web: xunda-med.com E-mail: xunda@xunda-med.com Specializes in development, production and sales of clinical testing equipment. Products include a range of electrolyte analyzer series, western blot system series and erythrocyte sedimentation rate analyzer series.

Yashraj Biotechnology

India • Navi Mumbai Tel: (91) 22-6216-6800 Web: yashraj.com E-mail: marketing@ 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 26601910 Web: szyhlo.com E-mail: marketing@szyhlo.com Specializes in developing, manufacturing, and distributing in vitro diagnostic instruments and reagents.

Zytomed Systems

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

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Nüve Tokra Medikal

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– AACC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 124 Alcor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 102 Biofire. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 122 Bioperfectus. . . . . . . . . . . . . . . . . . . . . . . . . . 22 117 DiaSys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 133 Dynex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 110 EliTech Group . . . . . . . . . . . . . . . . . . . . . . . . 10 105 Erba. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 107 Erba. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 135 Euroimmun. . . . . . . . . . . . . . . . . . . . . . . . . . . 35 – Euromedlab 2021. . . . . . . . . . . . . . . . . . . . . . 39 121 Feather. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 – IFCC Virtual Conference. . . . . . . . . . . . . . . . 10 109 Instrumentation Laboratory . . . . . . . . . . . . . . . 9 111 Instrumentation Laboratory . . . . . . . . . . . . . . 11 132 Mast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 115 Mayo Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . 15 129 NG Biotech. . . . . . . . . . . . . . . . . . . . . . . . . . . 29 112 NovaTech Immundiagnostica . . . . . . . . . . . . 12 119 Quantimetrix. . . . . . . . . . . . . . . . . . . . . . . . . . 19 103 Randox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 123 Serosep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 125 Singuway. . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 113 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 140 Snibe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 127 Veda Lab. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 130 Vicotex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 137 Vircell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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