Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Today, the U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC). The FDA has previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19. “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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.” These combination tests work by testing a single sample from a patient for multiple respiratory diseases, such as COVID-19 and the seasonal flu which can show similar symptoms. There are several important advantages to this combination testing. Taking just one sample from a patient may help alleviate the need for multiple samplings, which means less discomfort for the patient with faster and...

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