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FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.
On February 22, FDA issued a new Guidance for COVID-19 test developers entitled “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests: Guidance for Test Developers and Food and Drug Administration Staff.” The Guidance is designed to address the spread of several major variants carrying multiple mutations, the effects of the mutations on existing tests, and the resulting potential for an increase in the number of false negatives.