Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time

The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has made up for at least some of that lost time since getting its response strategy in order. In previous public health emergencies, approval for commercial laboratory tests to diagnose a pathogen has taken months, if not years. Eight weeks was the fastest on record. The first commercial test for COVID-19, from Roche, was approved just six weeks into the emergency. And since then literally dozens of new tests have received FDA Emergency Use Authorization (EUA), a total that grows literally every day. Here is the latest count as of April 17, 2020. COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test) Date Manufacturer(s) Test Receiving EUA Feb 4 CDC 2019 Real Time RT-PCR Diagnostic Test Panel March 2 New York State Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel March 13 Roche Cobas SARS-CoV-2 Test March 15 Thermo Fisher Scientific TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid […]