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FDA authorizes COVID-19 combination diagnostic for flu season


This is the third test approved for the detection and differentiation of the viruses that cause COVID-19 and the flu.

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) or the third diagnostic test aimed at identifying and differentiation of the viruses that cause the flu and COVID-19.

According to a news release, these forms of diagnostics test a single sample from a patient for multiple respiratory diseases that might show similar symptoms. Advantages of these forms of tests include that it alleviates the need to take multiple samples and they require fewer supplies such as swabs and personal protective equipment.

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

Previously, the FDA issued EUAs to two companies whose tests not only for the viruses that cause COVID-19 and flu, but also for other respiratory organisms, according to the release.

The administration is urging developers to work with the FDA on more of these combination tests that could be useful in conserving resources in the upcoming flu season during the COVID-19 coronavirus pandemic and has updated the molecular diagnostic EUA templates to add information on the tests which will facilitate the preparation, submission, and authorization of the EUAs, the release says.

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Jeff Andrews, MD