Top Suppliers of Medical Testing Kits in the USA and Globally

Medical testing kits are a common tool in several disciplines to allow healthcare professionals to test for genetic, autoimmune, or other diseases. This includes COVID-19, influenza, STDs, dengue fever, cancer, and other diseases. In this article, we’ll be covering some of the top companies developing or selling test kits for the coronavirus on Thomasnet.com, as well as the first companies to get emergency use authorizations (EUAs) from the FDA at the beginning of the pandemic. Finally, we’ve included information on the top companies selling general medical testing kits across the field, from molecular to sexually transmitted infection testing products.

At a glance:

Top COVID-19 Test Manufacturers on Thomasnet.com [December 2021]
FDA EUA Approved COVID-19 Test Manufacturers [April 2020]
Top Suppliers of General Medical Testing Kits

Top COVID-19 Test Manufacturers on Thomasnet.com [December 2021]

Well into the pandemic there is still high demand for COVID-19 testing kits. With the current large array of COVID-19 test kit suppliers (including more than 80 on Thomasnet.com alone), we’re covering the top test kit manufacturers on our platform below, sorted by annual revenue. Details for each company include its US headquarters location, annual revenue in US dollars, and its number of employees. More details on each company’s products follow the table.

Table 1: Top COVID-19 Test Kit Manufacturers on Thomasnet.com

*Information from the company website
**Information taken from Buzzfile
	Company	U.S. Headquarters	Annual Revenue	Number of Employees
1	Thermo Fisher Scientific	Waltham, MA	250+	1000+
2	Abbott Laboratories	Abbott Park, IL	100-249.9	1000+
3	Medybird	Dover, DE	25-49.9	200-499
4	Conductive Technologies	York, PA	10-24.9	100-199
5	RayBiotech	Norcross, GA	1-4.9	10-49
6	Alercell	Bozeman, MT	1-4.9	10-49
7	Epigentek Group	Farmingdale, NY	<1	1-9
8	Atila BioSystems	Mountain View, CA	<1**	1-9**
9	OraSure Technologies	Bethlehem, PA	<1*	500-999*
10	Accurate DNA & Drug Testing	Oakland, CA	<1**	10-49

Thermo Fisher Scientific is located in Waltham, MA. The company’s test kits include RT-PCR, fast PCR, and subkits for RT-PCR tests including RNase P, control, pooling assay, FluA and FluB, high throughput, RNA control, and other test kits.

Based in Abbott Park, IL, Abbott Laboratories supplies a range of COVID-19 tests, including over-the-counter home kits, antibody tests, and 13-minute lab tests. The company also offers professional products for medicine, nutrition, neuromodulation, diagnostics, diabetes care, and cardiovascular applications.

Medybird offers gloves, masks, touch-free hand dispensers, and 15-minute COVID-19 antigen test kits which employ non-invasive sample taking. The company is headquartered in the UK but is also located in the US in Dover, DE.

In York, PA, Conductive Technologies custom manufactures custom COVID-19 test kits. The company, which specializes in printed electronic sensors and circuits, is capable of custom sensors, well plates, and reagent development, as well as assembly, packaging, and quality.

RayBiotech is headquartered in Norcross, GA. The company offers COVID-19 visual antigen test kits, as well as IgM/IgG rapid test kits for Canadian companies. Their other offerings include arrays, ELISA kits, reagents, functional assays, flow cytometry, and other lab products.

Alercell, located in Bozeman, MT, specializes in vitro diagnostic rapid test kits. The company supplies antibody, rapid antigen, PCR, and fast PCR COVID-19 tests, and also offers tests for dengue, influenza, syphilis, and hepatitis A, B, and C.

Based in Farmingdale, NY, Epigenteck Group provides COVID-19 research test kits as well as proteins and antibodies. Their kits include an antibody, ELISA, binding inhibitor, convertase inhibitor, neutralizing antibody assay, and furin cleavage site blocker/inhibitor screening kits

Atila BioSystems manufactures tests for COVID-19, prenatal, cancer screening and detection, and infectious disease detection applications. The company, whose COVID-19 test is based on reverse transcription isothermal amplification, similar to RT-PCR, is located in Mountain View, CA.

OraSure Technologies, in Bethlehem, PA, offers 15-minute COVID-19 tests, home tests, and point-of-care professional rapid tests. They also offer testing kits for other diseases, as well as sampling tools and analysis services.

Accurate DNA & Drug Testing, based in Oakland, CA, supplies rapid professional and home COVID-19 test kits, as well as antibody, rapid molecular, and RT-PCR tests. The company also helps set up on-site testing, including temperature and symptoms checks.

FDA EUA Approved COVID-19 Test Manufacturers [April 2020]

With new manufacturers of COVID-19 tests constantly getting approval, these are the manufacturers to get FDA EUAs as of April 3. This table outlines details on the suppliers listed as having Emergency Use Authorization (EUA) approvals for their tests to be sold in the U.S., as shown on the FDA’s website. EUA approvals are products not generally approved by the FDA except in case of emergency situations when there are no better options (as in the case of the coronavirus pandemic). Companies that manufacture the tests are ranked in order of their approval by the FDA, from first to latest. Annual sales are in millions of U.S. dollars, and dashes indicate where information was unavailable or did not apply.

Table 2: FDA-approved Coronavirus Test Manufacturers as of April 3

*Source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd**Taken from the organization’s website
	Company/Organization	Test	Date Approved	Company’s U.S. Headquarters	Annual Sales
1	Centers for Disease Control and Prevention (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel	2/4/2020	Atlanta, GA*	—
2	Wadsworth Center, New York State Department of Public Health (CDC)	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	2/29/2020	Albany, NY*	—
3	Roche Molecular Systems, Inc.	cobas SARS-CoV-2	3/12/2020	Indianapolis, IN	250+
4	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	3/13/2020	Waltham, MA	250+
5	Hologic, Inc.	Panther Fusion SARS-CoV-2	3/16/2020	Marlborough, MA	250+
6	LabCorp	COVID-19 RT-PCR Test	3/16/2020	Burlington, NC	250+
7	Quidel Corporation	Lyra SARS-CoV-2 Assay	3/17/2020	San Diego, CA	100-249.9
8	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR	3/17/2020	Secaucus, NJ*	—
9	Abbott Molecular	Abbott RealTime SARS-CoV-2 assay	3/18/2020	Abbott Park, IL	100-249.9
10	DiaSorin Molecular LLC	Simplexa COVID-19 Direct assay	3/19/2020	Stillwater, MN	5-9.9
11	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	3/19/2020	Carlsbad, CA	50-99.9
12	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR assay	3/20/2020	Chandler’s Ford, U.K.*	—
13	Cepheid	Xpert Xpress SARS-CoV-2 test	3/20/2020	Sunnyvale, CA	250+
14	BioFire Defense, LLC	BioFire COVID-19 Test	3/23/2020	Salt Lake City, UT	100-249.9
15	Mesa Biotech, Inc.	Accula SARS-Cov-2 Test	3/23/2020	San Diego, CA	—
16	PerkinElmer Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	3/24/2020	Waltham, MA	—
17	Avellino Lab USA Inc.	AvellinoCoV2 test	3/25/2020	Menlo Park, CA*	—
18	BGI Genomics Co. Ltd.	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV	3/26/2020	Cambridge, MA*
19	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	3/27/2020	Lake Forest, IL*	—
20	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay	3/27/2020	Austin, TX	100-249.9
21	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	3/27/2020	Ann Arbor, MI*	—
22	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel	3/30/2020	Minneapolis, MN	5-9.9

The U.S. Centers for Disease Control, or C.D.C., is a government organization based in Atlanta, GA. The organization’s CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel was the first coronavirus test approved for use in the U.S. and should be used with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software.

Wadsworth Center, part of the New York State Department of Public Health, is located in Albany, NY. It developed and currently performs the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel test in-house.

In Indianapolis, IN, Roche Molecular Systems offers the cobas® SARS-CoV-2 Test, which produces results in roughly 4 hours and runs on the company’s cobas®6800 and 8800 systems. The company plans to produce 400,000 tests per week.

Thermo Fisher Scientific, which is headquartered in Waltham, MA, offers a 4-hour test in the TaqPath COVID-19 Combo Kit. The company expects to ramp up to producing two million tests per week.

Hologic, Inc. has created the Panther Fusion SARS-CoV-2 test, which works in three hours. The test runs on the company’s Panther Fusion system. Hologic, which plans to produce 600,000 tests per month, is headquartered in Marlborough, MA.

In Burlington, NC, LabCorp’s COVID-19 RT-PCR Test is processed by LapCorp itself after patient samples from physicians are sent to it. As of March 20^th, it has been able to perform 20,000 tests per day.

Quidel Corporation, headquartered in San Diego, CA, offers the Lyra SARS-CoV-2 Assay test. The test’s nucleic acid extraction can be run on either bioMerieux NucliSENS® easyMAG® system or EMAG system, while its RT-PCR stage can be run on the Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler® 480, or Qiagen Rotor-Gene Q. The company is planning to produce 50,000 tests per day by mid-April.

Quest Diagnostics Infectious Disease, in Secaucus, NJ, is also performing its own testing with its Quest SARS-CoV-2 rRT-PCR test, using samples sent from physicians. The company has also added Roche’s coronavirus test to expand its capacity to 25,000 tests per day.

Based in Abbot Park, IL, Abbott Molecular offers the Abbott RealTime SARS-CoV-2 assay test, which works on the company’s m2000 RealTime system. The company produces one million tests per week.

DiaSorin Molecular supplies the Simplexa COVID-19 Direct assay test, which reports results in one hour and runs on the LIAISON® MDX. The company is headquartered in Stillwater, MN.

GenMark Diagnostics offers the ePlex SARS-CoV-2 automated test, which runs on its ePlex system and takes two hours. The test has less than two minutes of hands-on time. GenMark Diagnostics is headquartered in Carlsbad, CA.

Primerdesign, based in Chandler’s Ford, U.K., has developed the two-hour Primerdesign Ltd COVID-19 genesis test, which can run on either Thermo Fisher Scientific’s Applied Biosystems 7500 Real-Time PCR System, Bio-Rad Technologies’ CFX Connect Real-Time PCR Detection System, or Roche’s LightCycler 480 II platform.

In Sunnyvale, CA, Cepheid has created the Xpert Xpress SARS-CoV-2 test, which runs on its GeneXpert® System and takes 45 minutes to detect the virus. Test kits include all the supplies needed to run the test.

BioFire Defense’s BioFire COVID-19 Test takes 45 minutes to get results and runs on the company’s FilmArray® system. The company, which also offers an external control kit for its test, is based in Salt Lake City, UT.

Mesa Biotech, in San Diego CA, has developed the Accula SARS-Cov-2 test, which shows results in 30 minutes. The test is handheld and designed for point-of-care facilities including nursing facilities, doctor’s offices, and temporary screening facilities.

PerkinElmer, headquartered in Waltham, MA, supplies the PerkinElmer New Coronavirus Nucleic Acid Detection Kit. The kit works with the company’s chemagic™ Viral DNA/ RNA 300 kit H96 and chemagic™ 360 instruments.

In Menlo Park, CA, Avellino Lab USA is offering the AvellinoCoV2 test, which the company itself performs using samples sent to it by healthcare workers. It is offering a turnaround time of 1-2 days.

BGI Genomics, in Cambridge, MA, offers its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV. The test, which takes 3 hours, can be run on the Applied Biosystems 7500 Real-Time PCR System.

Abbott Diagnostics Scarborough has created the ID NOW COVID-19 test, which offers results in five minutes and runs on the company’s six pound ID NOW^TM platform. The company’s diagnostics branch, which is planning to produce 50,000 tests per day, is headquartered in Lake Forest, IL.

Based in Austin, TX, Luminex Molecular Diagnostics supplies the NxTAG CoV Extended Panel Assay test, which works on the company’s MAGPIX® System. The company also offers the ARIES® System for coronavirus testing.

NeuMoDx Molecular, in Ann Arbor, MI, offers its NeuMoDx SARS-CoV-2 Assay test, to be used on the company’s NeuMoDx™ 288 and 96 Molecular Systems, which are automated. The test takes roughly an hour and a half.

Headquartered in Minneapolis, MN, QIAGEN supplies the QIAstat-Dx Respiratory SARS-CoV-2 Panel test, which can test 22 different diseases including COVID-19. The test is run on the company’s QIAstat-Dx Analyzer.

Top Suppliers of General Medical Testing Kits

Here we’re ranking the top companies in the in vitro diagnostics (IVD) market according to Kalorama Information. Please note this includes all companies that offer medical testing kits, not coronavirus testing kits specifically. The table below outlines information on the top ten companies in terms of annual revenue in 2017. Revenues are in billions of U.S. dollars and taken from the company’s website unless otherwise noted.

Table 3: Top Suppliers of General Medical Testing Kits

*** Data taken from https://kaloramainformation.com/product/the-top-25-ivd-companies-revenue-performance-products-strategies-market-activities/** Revenue for 2018*From Macrotrends.net
	Company	U.S. Headquarters	Annual Revenue	Year Founded
1	Roche Diagnostics	Indianapolis, IN	63.5**	1998
2	Thermo Fisher Scientific	Waltham, MA	25	1956
3	Philips	Cambridge, MA	20*	1891
4	Danaher Corporation (owns Beckman Coulter and Cepheid)	Washington, D.C.	15.5*	1919
5	Siemens Healthineers	Malvern, PA	15.2	2015
6	Becton Dickinson	Franklin Lakes, NJ	12.1	1897
7	LabCorp. Laboratory Corporation of America	Burlington, NC	10.3*	1978
8	Quest Diagnostics	Secaucus, NJ	7.4	1967
9	Grifols	Los Angeles, CA	4.8*	1987
10	Hologic	Marlborough, MA	3*	1986

Roche Diagnostics, in Indianapolis, IN, specializes in IVDs for healthcare laboratories. Their offerings include immuno-and clinical chemistry assays, laboratory automation, hematology, urinalysis, patient self-testing, custom biotech, and molecular, tissue, and point-of-care diagnostics products. Roche also offers biopharmaceuticals.

Based out of Waltham, MA, Thermo Fisher Scientific serves the life sciences, industrial and applied science, clinical and diagnostic, and laboratory sectors. The company offers microbial, clinical, diagnostics, contamination, impurity, forensics, PCR, sequencing, DNA and RNA purification, protein analysis, and air and water analysis kits.

Philips supplies medical supplies for labor, delivery, neonatal, general ward, cardiology, ICU, operating room, emergency medical, and emergency department applications. The company is headquartered in Cambridge, MA.

Danaher Corporation, which owns both Beckman Coulter and Cepheid as well as 20 other companies, is based in Washington, D.C. Beckman Coulter specializes in IVDs and reproductive health products, while Cepheid is a molecular diagnostics company.

Siemens Healthineers, in Malvern, PA, offers a range of diagnostic products including assays, analyzers, lab automation equipment, and molecular and drug testing diagnostics products. The company also offers medical imaging, point-of-care testing, digital health products, IT products, and consulting services.

In Franklin Lakes, NJ, Becton Dickinson offers immunoassay and syphilis test kits as well as susceptibility testing reagents. The company’s offerings include 29 categories of products for medical applications.

LabCorp, also known as Laboratory Corporation of America, is headquartered in Burlington, NC. The company specializes in clinical laboratory and drug development services and currently offers a test kit for COVID-19 as well as hundreds of other tests.

Quest Diagnostics, headquartered in Secaucus, NJ, offers tests for allergy, cardiology, dermatology, endocrinology, anatomic pathology, gastroenterology, genetics, geriatrics, hematology, infectious disease, internal medicine, nephrology, neurology, oncology, pediatrics, primary care, pulmonology, toxicology, transplant, urology, and women’s health.

Based out of Los Angeles, CA, Grifols supplies plasma-derived medicine, diagnostics systems, and hospital pharmacy products. The company offers diagnostics for infectious diseases, autoimmunity, hemostasis, and biological drug monitoring.

Hologic supplies breast, skeletal, gyn, and diagnostic products, including tests for cytology, perinatal, and molecular applications. The company is headquartered in Marlborough, MA.

Top Suppliers of Medical Testing Kits in the USA and Globally—Conclusion

This guide has outlined the basic facts and summaries of companies offering or developing coronavirus test kits and general medical testing kits. If you’re a US/Canadian company that manufactures a coronavirus-specific testing kit, please get listed on Thomas and we will make sure to update your company information on our platform. If you’re more interested in sourcing medical kits, we invite you to try out our supplier search on Thomasnet.com, which has information on over 400 suppliers of test kits across North America.

Copyright and Trademark Notices

cobas® and LightCycler® are registered trademarks of Roche Molecular Systems. Inc., Indianapolis, Indiana.
NucliSENS® and easyMAG® are registered trademarks of bioMerieux, Inc., Durham, North Carolina.
Applied Biosystems® 7500 is a registered trademark of Applied Biosystems, Waltham, Massachusetts.
LIAISON® is a registered trademark of DiaSorin, Inc., Stillwater, Minnesota.
GeneXpert® is a registered trademark of Cepheid, Sunnydale, California.
FilmArray® is a registered trademark of Biofire Defense, Salt Lake City, Utah.
chemagic™ is a trademark of PerkinElmer, Waltham, Massachusetts.
ID NOW^TMis a trademark of Abbott Laboratories, Abbott Park, Illinois.
MAGPIX® and ARIES® are registered trademarks of Luminex Corporation, Austin, Texas.
NeuMoDx™ is a trademark of NeuMoDxMolecular, Inc., Ann Arbor, Michigan.