Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic.
Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.
The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). According to a news release, test results are made available after about 36 minutes.
Cepheid noted that the addition of a third gene target to the Plus version of the Xpert Xpress diagnostic platform offers more coverage to mitigate the potential effects of future viral genetic drift as variants of COVID-19 continue to develop.
“During this time of year, healthcare providers can face a range of viral infections whose symptoms overlap with COVID-19, including Influenza A, Influenza B, and respiratory syncytial virus. Having a quick and accurate test to detect current and future variants of the COVID-19 and influenza viruses is becoming increasingly important, ” Cepheid CMO & CTO Dr. David Persing said in the release. “By taking a single sample and running a single, highly sensitive, multiplex test that detects and differentiates all four viruses, actionable results can be provided to help us make better decisions at the cutting edge of our healthcare systems. ”