FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...
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