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Combination flu and COVID-19 tests are in the works for virus season

Combination flu and COVID-19 tests are in the works for virus season


At-home testing company Cue asked the FDA to clear its combo test

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Cue COVID-19 test in a package on a desk next to the reader.
Cue has a COVID-19 test and wants to add on a flu test.
Photo by Victoria Song / The Verge

The past two years have seen relatively quiet flu seasons — a welcome development as hospitals and the public health system focused on managing waves of COVID-19. But experts are expecting flu to make a comeback this winter, and people will need to differentiate between the two illnesses with very similar symptoms.

At-home testing companies are asking the Food and Drug Administration to authorize combination tests that can scan for both COVID-19 and influenza in a single sample. Lucira Health asked the agency to sign off on its dual test in May, and Cue Health announced Tuesday that it submitted a request on September 30. The FDA authorized a combination test made by Labcorp in May, but that test requires people to swab their nose and mail it to a lab.

Having a fast way to differentiate flu from COVID-19 would be particularly useful in figuring out what types of medications to treat people with. Antiviral medications for both diseases have to be given quickly after someone starts feeling sick. If someone has a fever and body aches and tests negative for COVID-19, the extra wait to get a positive flu test might make something like Tamiflu less effective.

“We believe delivering a highly accurate at-home test for both COVID-19 and flu can greatly improve access to appropriate therapeutics in the window of time when they are most effective,” Erik Engelson, president and CEO of Lucira Health, said in a statement.

Both companies make at-home molecular virus tests, which look for bits of viral genetic material in a sample. They’re more accurate than at-home antigen tests — the type of tests most people use for at-home COVID-19 testing — but they’re also more expensive. Cue’s reader and three tests are over $300, which leaves it inaccessible to many people.

Both Lucira and Cue asked the FDA for emergency use authorization of their combination tests — a designation that lets the agency clear tests more quickly during an emergency when other options aren’t available. They might be able to get that type of sign-off because they’re new types of tests. The FDA said in September that it would ask most new COVID-19 tests to go through the normal regulatory pathway but carved out an exception for tests that “fulfill an unmet need.” An at-home, rapid combination test would meet that bar.

Correction October 4th, 3:45PM ET: An earlier version of the story said that Cue submitted a request to the FDA Tuesday. The submission was announced today, but submitted on September 30. We regret the error.