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.
|Abbott (ABT)||U.S.||RealTime SARS-CoV-2 test||EUA by FDA on Mar.18|
|Quidel Corp (QDEL)||U.S.||Lyra SARS-CoV-2 Assay||EUA by FDA on Mar.17|
|Quest Diagnostics (DGX)||U.S.||SARS-CoV-2 rRT-PCR test||EUA by FDA on Mar.17|
|Hologic Inc. (HOLX)||U.S.||Panther Fusion SARS-CoV-2 assay||EUA by FDA on Mar.16|
|LabCorp (LH)||U.S.||COVID-19 RT-PCR test||EUA by FDA on Mar.16|
|Roche||Switzerland||Cobas SARS-CoV-2 Test||CE Mark, EUA by FDA on Mar.13|
|Thermo Fisher Scientific Inc. (TMO)||U.S.||TaqPath COVID-19 Combo Kit||EUA by FDA on Mar.13|
|Aytu BioScience, Inc. (AYTU)||U.S.||IgG/IgM Rapid test||CE Mark, EUA being pursued, licensed from L.B. Resources|
|Becton, Dickinson and Co. (BDX)||U.S.||Max VIASURE COVID-19 RT-PCR test||CE Mark|
|BGI Genomics Co. Ltd||China||Real-Time Fluorescent RT-PCR test||CE Mark, EUA Pending, Available in U.S.|
|Co-Diagnostics Inc. (CODX)||U.S.||Logix Smart (COVID-19) test||CE Mark, EUA pending; Available in U.S.|
|Diatherix Eurofins||U.S.||COVID-19 Panel||Available in U.S.|
|Fulgent Genetics (FLGT)||U.S.||COVID-19 test||Available in U.S., EUA filing in coming weeks|
|Danaher Corp (DHR)||U.S.||Allplex 2019-nCOV Assay||CDC EUA|
|OPKO’s BioReference Lab (OPK)||U.S.||COVID-19 test||Available in U.S.|
|Novacyt S.A (NCYT.L)||U.K.||COVID-19 test||CE Mark, EUA filing planned|
|QIAGEN N.V. (QGEN)||Netherlands||QIAstat-Dx respiratory panel 2019-nCoV test||CE Mark|
|Seegene Inc.||South Korea||Allplex 2019-nCOV Assay||CE Mark, South Korea Ministry of Food and Drug Safety approval|
|Snibe Diagnostics||China||MAGLUMI 2019-nCoV IgM/IgG Kits||CE Mark|
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