FDA grants emergency use for at-home COVID-flu test


Center for Infectious Disease Research and Policy.

Jim Wappes.

Medical technology company Lucira Health, Inc, of Emeryville, California, announced today that the US Food and Drug Administration (FDA) has granted its dual test for COVID-19 and influenza emergency use authorization (EUA).

The company, however, recently filed for bankruptcy, citing the prolonged FDA authorization process.

The Lucira COVID-19 & Flu Home Test is approved for over-the-counter (non-prescription) use at home and for other non-laboratory sites. The company said the molecular test performed similarly for COVID-19 and influenza A and B as polymerase chain reaction (PCR) tests in clinical trials. It is the first at-home COVID and flu test to be granted an EUA and the first approved at-home flu test.

It is a nucleic acid amplification test that uses the same technology as both of Lucira’s commercialized FDA-authorized COVID-19 tests. It fits in the palm of a person’s hand, assesses nasal swabs, and runs on two AA batteries. USA Today says it costs about $70 in Canada, and Lucira will announce a US price tag in the future.

“Having an at-home molecular test now available should really help people know how to keep their families safe and seek appropriate treatment when they’re ill,” Davey Smith, MD, head of the Division of Infectious Disease and Global Public Health at the University of California–San Diego, said in the Lucira news release.

“We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization,” said Lucira CEO Erik Engelson, MBA, MS. “Unfortunately we were unable to bridge what became a protracted authorization cycle time… The Lucira COVID-19 & Flu Home Test would have been especially useful during the recent, severe respiratory season, and we had produced inventory for an anticipated autumn 2022 launch.”

Lucira is seeking a strategic or financial partner to resume manufacturing and development of additional home diagnostic tests.