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 about how the bankruptcy affects their ability to manufacture and sell the newly authorized test kit, which can detect influenza A and B.