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FDA Issues New EUA for Multiplex SARS-CoV-2, Flu Test

FDA maze of regulations

As flu season approaches, new multiplex SARS-CoV-2 test EUA granted to Roche.

The US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) Sept. 3, 2020, for a new multiplex test that can be used to test for SARS-CoV-2, influenza A, and influenza B. The EUA letter states that this test can be used “for the simultaneous qualitative detection and differentiation” of the RNA of these three viruses. The FDA EUA specifically excludes influenza C as a virus that can be tested using this EUA.

Roche Molecular Systems, Inc., received this EUA for its cobas SARS-CoV-2 and Influenza A/B Test, for use on the cobas 6800/8800 Systems. The test is the fourth multiplex SARS-CoV-2 test to receive an EUA from the FDA since the beginning of the COVID-19 pandemic.

According to a press release by Roche, this test is the “first commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample.”

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Thomas Schinecker, CEO of Roche Diagnostics said in a press release. 

Related Resources:

Roche: Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

FDA EUA Letter: cobas SARS-CoV-2 & Influenza A/B