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March 30 Update: New Information on Diagnostic Testing for SARS-CoV-2

March 31, 2020

Thank you for your interest in development of diagnostics for SARS-CoV-2.  On March 30, 2020, the FDA updated the frequently asked questions on diagnostic testing to include new and updated information on:

  •  When FDA authorizes a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?
  • I am developing a COVID-19 assay that is a modification of a previously EUA authorized COVID-19 assay. Do I need to start from scratch with my validation or can I validate my test with a bridging study?