The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy

STAT February 26, 2023
Brittany Trang

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.

“This is a major milestone for Lucira Health and for at-home diagnostics, and I can’t thank our employees and partners enough for seeing this through, and of course, for the FDA’s recognition,” said Lucira CEO Erik Engelson in a statement to STAT, making no mention of the company’s bankruptcy. At the time of publication, Lucira had not answered questions...

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