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COVID-19 Diagnostic Tests

Diagnostics play a key role in combating a flu pandemic because the test results not only help to know if a person has been infected by the virus but will also help to take measures to prevent the infection spread.

As the COVID-19 continues to sweep across the world, all the countries are racing to develop reliable diagnostic tests as well as a vaccine or treatment against the virus.

Listed below are the diagnostic tests that have been rolled out by some of the public listed companies. The list excludes tests conducted by Private Labs or Non-profit organization.

The diagnostic tests are performed on samples which are collected as swabs from a patient's nose and throat or as sputum, and sometimes on blood collected from a patient. These tests have either been validated in-house or have secured *FDA's Emergency Use Authorization (EUA) or **European Medicines Agency's CE Mark.

*The Emergency Use Authorization granted by the FDA permits the use of an unapproved medical product in the U.S. during a declared emergency. **The CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. (Source: Your Europe)

This page will be updated as and when the new tests are launched by the public listed companies.

Updated on March 26, 2:06 AM ET.

CompanyLocationTestRegulatory Status
Cepheid/Danaher Corp (DHR)U.S.Xpert Xpress SARS-CoV-2EUA by FDA on Mar.21
DiaSorin S.p.A(DSRLF.OBU.S.Simplexa COVID-19 Direct EUA by FDA on Mar.20
GenMark Diagnostics (GNMK)ItlayePlex SARS-CoV-2 TestEUA by FDA on Mar.19
Abbott (ABT)U.S.RealTime SARS-CoV-2 testEUA by FDA on Mar.18
Quidel Corp (QDEL)U.S.Lyra SARS-CoV-2 AssayEUA by FDA on Mar.17
Quest Diagnostics (DGX)U.S.SARS-CoV-2 rRT-PCR testEUA by FDA on Mar.17
Hologic Inc. (HOLX)U.S.Panther Fusion SARS-CoV-2 assayEUA by FDA on Mar.16
LabCorp (LH)U.S.COVID-19 RT-PCR testEUA by FDA on Mar.16
Roche SwitzerlandCobas SARS-CoV-2 TestCE Mark, EUA by FDA on Mar.13
Thermo Fisher Scientific Inc. (TMO)U.S. TaqPath COVID-19 Combo KitEUA by FDA on Mar.13, CE Mark
Aytu BioScience, Inc. (AYTU)U.S.IgG/IgM Rapid testCE Mark, EUA being pursued, licensed from L.B. Resources
Becton, Dickinson and Co. (BDX)U.S.Max VIASURE COVID-19 RT-PCR testCE Mark
BGI Genomics Co. Ltd ChinaReal-Time Fluorescent RT-PCR testCE Mark, EUA Pending, Available in U.S.
Co-Diagnostics Inc. (CODX) U.S.Logix Smart (COVID-19) testCE Mark, EUA pending; Available in U.S.
Diatherix EurofinsU.S. COVID-19 PanelAvailable in U.S.
Fulgent Genetics (FLGT) U.S.COVID-19 testAvailable in U.S., EUA filing in coming weeks
Danaher Corp (DHR)U.S.Allplex 2019-nCOV AssayCDC EUA
OPKO's BioReference Lab (OPK) U.S.COVID-19 testAvailable in U.S.
Novacyt S.A (NCYT.L)U.K.COVID-19 testCE Mark, EUA filing planned
QIAGEN N.V. (QGEN)NetherlandsQIAstat-Dx respiratory panel 2019-nCoV testCE Mark
Seegene Inc.South KoreaAllplex 2019-nCOV AssayCE Mark, South Korea Ministry of Food and Drug Safety approval
Snibe DiagnosticsChina MAGLUMI 2019-nCoV IgM/IgG KitsCE Mark

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