The FDA Has Cleared the First Home Flu and COVID Test – But There’s a Catch

Last week, the FDA 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. The timing of the FDA’s decision has sparked criticism of the agency’s pace. According to Lucira’s February 24 bankruptcy hearing, the company filed for an EUA in May 2022 and anticipated receiving it in August, well ahead of flu season. This estimate was based on its experience with its EUA submission for its home COVID-19 test. Read more from STAT news here.