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

For Immediate Release:: July 02, 2020

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 more comprehensive results. In addition, combination tests require fewer supplies, such as swabs and personal protective equipment, and reduce pressure on the supply chain for reagents.

The FDA encourages additional developers to work with the FDA on combination tests that may be useful in preserving critical testing resources in the upcoming flu season during the COVID-19 pandemic. The FDA has updated the Molecular Diagnostic EUA templates to add information about these types of tests to help facilitate the preparation, submission, and authorization of EUAs of combination tests that address the COVID-19 public health emergency.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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