NEW YORK – Cepheid announced on Thursday that it has obtained the CE mark for an expanded combination COVID-19 test. The firm expects to begin shipping the new test to countries that accept the CE mark this month.
The Xpert Xpress CoV-2/Flu/RSV plus is a rapid molecular diagnostic test to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. It obtained Emergency Use Authorization from the US Food and Drug Administration last month.
In a statement, the Sunnyvale, California-based Danaher subsidiary said that the new plus version of the test adds a third gene target for SARS-CoV-2 detection in order to "meet the challenge of future viral mutations."
Cepheid said the Xpert Xpress CoV-2/Flu/RSV plus assay is designed for use on any of the firm's over 35,000 GeneXpert systems placed worldwide, with results delivered in approximately 36 minutes.
"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," said David Persing, Cepheid's chief medical and technology officer.
"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," Persing added, noting that 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 frontline decisions within healthcare systems.
Cepheid's original SARS-CoV-2 is on an FDA list of assays that could be impacted by viral variants due to point mutations in its N gene target, but the agency has noted that the test's E gene target is not affected, the overall impact is likely to be small, and that it provided the information "out of an abundance of caution."