Cepheid receives CE mark for test detecting COVID-19 and Flu

Cepheid has received the CE mark 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 third 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.

Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid, said: “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. 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.”

Xpert Xpress CoV-2/Flu/RSV plus is expected to begin shipping to countries accepting CE-marked products this month.