The United States Food and Drug Administration (FDA) has recently taken a significant step in the battle against COVID-19 by announcing the clearance of the first over-the-counter (OTC) rapid antigen test for COVID-19. This noteworthy development introduces the Flowflex COVID-19 Antigen Home Test, innovatively developed by ACON Laboratories, as a reliable, accessible testing option for the general public. The test, having successfully navigated the traditional FDA premarket review pathway, emerges as the second at-home COVID-19 test to achieve this feat. Notably, this clearance is not merely a routine authorization; it signals a remarkable advancement in the field of diagnostic tools, especially in the context of infectious diseases.
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