FDA Approves First At-Home COVID and Flu Test for OTC Use

The FDA has granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, marking a significant milestone as the first over-the-counter test capable of detecting both COVID-19 and influenza without a prescription. The test, which provides results in approximately 15 minutes via a nasal swab, is notable for its high accuracy, with a 99% accuracy rate for negative COVID-19 cases and 92% for positive cases, alongside robust results for Flu A and B[1][2]. This authorization, conducted through a traditional premarket review rather than emergency use, establishes new special controls for labeling and performance, paving the way for the development of similar tests by streamlining the regulatory process[2].