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New at-home COVID and flu test authorized by FDA

The Food and Drug Administration announced Feb. 24 that it authorized a new OTC test. Photo: Sarah Silbiger/Getty Images

The FDA on Friday authorized the first over-the-counter at-home test that can detect both the flu and COVID-19.

Driving the news: The FDA issued an emergency use authorization for the Lucira COVID-19 & Flu Test, a single-use test kit “that provides results from self-collected nasal swab samples in roughly 30 minutes.”

  • No prescription is needed for the test, which is performed using nasal swab samples self-collected by people ages 14 years and older or collected by adults for individuals 2 years of age and older.

What they’re saying: Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, called the authorization "a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”

Meanwhile, Lucira Health, the company behind the test, announced earlier this week that it had filed for Chapter 11 bankruptcy protection and intends to pursue a sale of its business.

  • Lucira could not immediately be reached for comment on the FDA’s authorization and when tests will be available.

This is a developing story. Please check back for updates.

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