Cepheid announced today that it received FDA emergency use authorization for its Xpert Xpress SARS-CoV-2/Flu/RSV diagnostic test.
The Danaher Corp. (NYSE:DHR) subsidiary’s rapid molecular diagnostic test for detecting the viruses causing COVID-19, Flu A, Flu B and RSV infections in a single patient can be used in tandem with any of Cepheid’s GeneXpert systems across the world, with results provided in approximately 36 minutes, according to a news release.
Sunnyvale, Calif.-based Cepheid previously announced an expansion program for its capacity and expects that the program will make its first impact in the fourth quarter of this year with additional capacity ramping planned through 2021.
Cepheid received EUA for the bedside Xpert Xpress SARS-CoV-2 test at the very beginning of the pandemic in March and anticipates that it’s new combination test will begin shipping to U.S. customers this week with European availability slated for November.
“Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus,” Cepheid chief medical & technology officer Dr. David Persing said in the release. “The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system.”
“The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve — for the coming Flu season and beyond,” added Cepheid President Warren Kocmond. “Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies — including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more.”