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mti-FDA-Clears-CDC

 

A test that can diagnose either influenza or COVID-19 from a single patient sample has won marketing authorization from the US Food and Drug Administration.

The test, which was developed by the Centers for Disease Control and Prevention (CDC), is the third diagnostic that can differentiate between the two diseases to be granted an emergency use authorization (EUA). The FDA previously cleared Qiagen NV’s QIAstat-Dx Respiratory SARS-CoV-2 panel in March and the BioFire Respiratory Panel 2.1 from Biofire Diagnostics LLC in May. But while the CDC test is targeted, the QIAGEN and BioFire panels detect many other respiratory infections in addition to influenza and the novel coronavirus.

COVID-19 and influenza are both caused by coronaviruses, and may produce similar symptoms. Therefore, the FDA anticipates that the CDC test will be crucial as the fall and winter flu season approaches.

“This is another example of the FDA working with test developers to bring important diagnostics to Americans,” FDA Commissioner Stephen Hahn said in a 2 July statement. “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.”

The combination tests offer a range of advantages testing for each virus separately, the FDA said. For example, collecting only one sample minimizes patient discomfort and allows for faster and more complete diagnosis, while also preserving supplies such as swabs, personal protective equipment, and reagents.

In conjunction with the authorization of the CDC test, the FDA also announced on 2 July that it has updated its EUA template for molecular diagnostics to include more information and additional recommendations about the development of tests that can detect both COVID-19 and influenza.

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