FDA’s Emergency Use Authorization Picking Up, Seven COVID-19 Tests Available
Diagnostic companies are pushing ahead with developing testing technologies for COVID-19. As of Friday, AdvaMed released a list of seven tests that have received emergency use authorization from FDA:
- Abbott RealTime SARS-CoV-2 Test
- DiaSorin Molecular Simplexa COVID-19 Direct Kit
- GenMark ePlex SARS-CoV-2 Test
- Hologic Panther Fusion SARS-CoV-2 Assay
- Quidel Corp. Lyra SARS-CoV-2 Assay
- Roche Cobas SARS-CoV2 Test
- Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
“The medical technology industry has always been front and center during any public health emergency, and it is no different with the coronavirus. Many companies are adding third shifts, working 24/7, and adding new production lines in order to provide patients and health care providers what they need to detect, contain and treat this virus,” said AdvaMed president and CEO Scott Whitaker in an association press release. “It truly is incredible to watch our entire medtech community rally to this global cause. We thank these diagnostics companies for rapidly developing coronavirus tests, and we thank Dr. Hahn and the FDA for working so hard to authorize them quickly.”
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