FDA Authorizes First COVID-19 Test For Self-Testing At Home

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first coronavirus disease 2019 (COVID-19) diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit developed by Lucira Health, Inc. is a molecular (real-time loop mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. In a Community Testing Study, where the Lucira test was compared to a FDA authorized known high-sensitivity SARS-CoV-2 test, Lucira achieved . . .