EYECARE: Coronavirus BRIEFING: Crisis Response Tactics FDA OKs Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use By Staff Wednesday, October 9, 2024 6:09 AM The FDA authorized the first at-home dual flu and COVID antigen test outside of emergency use authorities. Today, the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu). This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization. Head over to MedPage Today to read more about it.