Lucira's home test for flu and COVID-19 gets U.S. FDA nod for OTC use

[February 28, 2023]  (Reuters) -Lucira Health said on Monday the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for its combination diagnostic test for COVID-19 and the flu, making it the first to be available over-the-counter.

The test — called Lucira COVID-19 & Flu Home Test — is a single-use, at-home rapid test kit that provides results from self-collected nasal swab in about 30 minutes.

Shares of the medical test maker rose more than four-fold to 66 cents in premarket trade.

The FDA's authorization, which came on Friday, allows the test to be purchased without a prescription and performed completely at home by individuals aged 14 years or older or collected by an adult for children two years or older.

The development comes days after Lucira filed for bankruptcy protection in the United States, and said it intended to pursue a sale of its business.

"Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through," said CEO Erik Engelson.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/

The company was hoping to launch the test during autumn last year — in time for the 2022 flu season — but remains confident that the test will play a key role in upcoming periods of severe respiratory disease.

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

(Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber and Uttaresh Venkateshwaran)

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