Cepheid has announced that it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress CoV-2/Flu/RSV plus, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections from a single patient sample.
The new plus version of the test provides a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations. Xpert Xpress CoV-2/Flu/RSV plus is designed for use on any of Cepheid's over 35,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.
Multiple variants of the virus that causes COVID-19 have been documented globally during the pandemic. Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Adding a 3rd gene target to the plus version of Cepheid's CoV-2/Flu/RSV test delivers broader coverage to mitigate the possible effects of future viral genetic drift.
"This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with COVID-19, including Flu A, Flu B, and respiratory syncytial virus. Having a fast and accurate test that is designed to detect current and future variants of the viruses that cause COVID-19 and influenza will become increasingly important," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "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."
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