FDA Authorizes First At-Home Combo Test for COVID and Flu

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Feb 25, 2023 --  The Food and Drug Administration has granted emergency use authorization for the first over-the-counter, at-home test that detects both COVID-19 and influenza, the agency announced Friday.

The test made by Lucira Health uses a self-collected nasal swab and gives a result in about 30 minutes. In clinical studies, the test correctly identified 99% of negative and 90% of positive influenza A samples and 100% of negative and 88% of positive COVID samples. 

Lucira will keep conducting tests on the detection of influenza B, which didn’t have enough cases to be included in the study, the FDA said.

The combo test is “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.

It’s unclear when the test will be available to the public because Lucira Health announced Wednesday that it was filing for Chapter 11 bankruptcy. 

Lucira said the easing of COVID restrictions in 2022 created lower demand for its COVID tests. The company expected EUA for the combo test to be granted in August 2022, ahead of flu season, but the protracted review process led to a further reduction in revenue, Lucira said in a statement.

The company it said expects to keep operating while seeking a buyer for the company.

Another complication for consumers is that the Biden administration announced that the national COVID public health emergency will end on May 11. That means, among other things, that the free COVID testing will end. People will have to buy at-home tests, either with insurance or out of pocket.