FDA clears its first OTC home antigen test for COVID-19. No, really

No, you didn’t set your clocks too far back for the end of daylight saving time. This week, the FDA granted its first full, bona fide clearance to an over-the-counter home antigen test for COVID-19, and its first to carry an official 510(k) for use in children under age 18.

Since 2020, the agency has granted emergency use authorizations to dozens of rapid, antigen-based coronavirus tests and hundreds of lab-based molecular diagnostics under its pandemic-era authorities.

And, while the U.S. government’s public health emergency declaration expired this past May, many EUAs still remain in effect. In this specific category of at-home, OTC tests, the agency currently lists 37 products with active green lights.

The Flowflex COVID-19 antigen home test, developed by ACON Laboratories, initially received an EUA in 2021. It now marks the second home COVID-19 test to successfully complete the FDA’s traditional premarket review pathway—following the de novo clearance claimed this past June by Cue Health for its at-home molecular-based test.

The visually read Flowflex test is designed to be used within six days of symptoms, and it’s indicated for children as young as 2 years old. The FDA recommended screening at least twice over three days, with at least 48 hours between results.

“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” the FDA’s device center director, Jeff Shuren, M.D., said in a statement. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities.”

The FDA began outlining its transition plan for not just diagnostic makers but all medical product manufacturers earlier this year, after starting to wind down its emergency authorization program in late 2022. 

That includes companies holding more than 950 authorizations granted over the past three years, spanning more than 430 different devices for diagnosing, treating and preventing COVID-19. EUAs have been given to everything from at-home tests to hospital ventilators to face masks, all of which will need to eventually obtain full FDA green lights to stay on the market.