Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.
Sunnyvale, California-based Cepheid 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).
Nearly one year ago, the company received EUA for the Xpert Xpress testing platform. According to a news release, the “plus” version of the test offers a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations.
The company touts the test as capable of delivering results in approximately 36 minutes. It expects to begin shipping to U.S. customers in the next few weeks.
“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,” Cepheid chief medical & technology officer Dr. David Persing said in the release. “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.”