FDA approves the first combination at-home test for flu and COVID
Since health symptoms for the flu and COVID are similar, the new at-home test will be a “major milestone,” said the FDA, however, the test's manufacturer has filed for bankruptcy, leaving its availability date uncertain.
The Food and Drug Administration issued an emergency use authorization for the first combination test for flu and COVID on Friday. The over-the-counter at-home diagnostic test can differentiate and detect the flu and COVID-19, giving consumers an easy way to get a quick diagnosis for a runny nose. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
The test “is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”
When available, the Lucira test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19.
The test was developed by Lucira Health, a California company that was also the first to receive FDA approval for the at-home rapid COVID tests in 2020. However, FDA approval came too late for the California-based company, which filed bankruptcy last week after the lengthy authorization process which caused it to miss out on combined test sales in the 2022-2023 flu season. As a result, Lucira laid off 68% of its staff while it continues to search for a buyer.
“We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization,” said Erik Engelson, President and CEO of Lucira Health. “We remain confident in the role that the new test can play in future respiratory seasons and are honored to have received the first authorization for such a home test.”
The company believes that its at-home, diagnostic products are a critical third leg of the stool that also includes telehealth and home prescription delivery for the future of safe, home-based health care, said Lucira in a release on Monday.