February 25, 2023 – The Food and Drug Administration has granted emergency use authorization for the primary over-the-counter home test that detects each COVID-19 and influenza. Agency announced Friday.
Lucira Health's test uses a self-collected nasal swab and provides a lead to about half-hour. In clinical trials, the test appropriately identified 99% of negative and 90% of positive influenza A samples, and 100% of negative and 88% of positive COVID samples.
Lucira will proceed testing to detect influenza B because there should not enough cases to incorporate it within the study, the FDA said.
The combination test is “an important milestone in providing consumers with greater access to diagnostic tests that can be performed entirely at home,” said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
It is unclear when the test shall be available to the general public, as Lucira Health announced Wednesday that it will file for Chapter 11 bankruptcy.
Lucira said the easing of COVID restrictions in 2022 has led to lower demand for its COVID tests. The company had expected the EUA for the combo test to be granted in August 2022, before flu season, however the lengthy review process has led to an extra decline in sales, Lucira said in a statement.
The company expects to take care of operations while it looks for a buyer, it said.
Further complicating things for consumers is that the Biden administration has announced that the national COVID health emergency will end on May 11. Among other things, which means free COVID testing will end. People can have to buy at-home tests, either with insurance or out of pocket.