Lucira Health’s test takes about 30 minutes to deliver results from a self-collected nasal swab. It detects influenza A and B, as well as SARS-CoV-2.
Jeff Shuren, MD, JD, 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,” in a news release. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs,” Dr. Shuren said.
Two days before the FDA issued its EUA for the test, Lucira Health filed for Chapter 11 bankruptcy and said it would try to sell the business, according to Politico. The company said it had expected the FDA to issue the EUA in August 2022, ahead of flu season, “though the FDA’s approval process became protracted.” Lucira said it will have more information on how the bankruptcy filing may affect the rapid test’s rollout, manufacturing capacity and price at a later time.
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