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Updated Cepheid SARS-CoV-2, Flu, RSV Test Nabs FDA EUA

NEW YORK – Cepheid announced on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a new version of its multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.

The new Xpert Xpress COV-2/Flu/RSV plus test adds a third gene target for SARS-CoV-2 to detect future viral mutations of the virus. The addition "delivers broader coverage to mitigate the possible effects of future viral genetic drift," the Danaher subsidiary said in a statement.

The test is designed for use on any Cepheid GeneXpert system and delivers results in approximately 36 minutes, the Sunnyvale, California-based company said. Cepheid expects to begin shipping the test to customers in the US in the next few weeks.

"The ability to collect one sample and run a single, highly sensitive multiplexed test that detects and differentiates all four viruses will provide actionable results to inform better front-line decisions within our healthcare systems," said David Persing, Cepheid's chief medical and technology officer.

The first version of the test received EUA from the FDA last year.

In July, Cepheid announced a $28 million award from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for product development related to the multiplex test and a pan-coronavirus test.