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Lucira Health Molecular COVID/Flu Test Gets FDA Emergency Use Authorization

NEW YORK – The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a molecular COVID-19/flu test from Lucira Health.

The Lucira COVID-19 & Flu test was authorized for use at the point of care. According to the agency, it is the first molecular COVID-19 test to receive authorization following collaboration with the US National Institutes of Health's Independent Test Assessment Program (ITAP), which was created to speed up the regulatory review of over-the-counter COVID-19 tests.

The RT-LAMP-based test, developed by Emeryville, California-based Lucira, is for single use. It detects and differentiates between SARS-CoV-2, influenza A, and influenza B viral RNA in anterior nasal swab samples collected by a healthcare provider from individuals suspected of having COVID-19. The test is for use by CLIA-certified laboratories only.