Cepheid Achieves CE Marking Under IVDR for Xpert® Respiratory Panel

Cepheid, a Danaher company, announced it has achieved CE marking under the EU IVDR for its Xpert Respiratory Panel. The multiplex PCR test is designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab, supporting diagnosis of suspected infectious respiratory tract infection alongside other clinical and pathological factors. Cepheid said respiratory infections are often managed as influenza-like illnesses due to overlapping nonspecific symptoms, making pathogen identification challenging. The company positioned the panel as a tool for diagnostic stewardship by enabling testing strategies on a single GeneXpert system, from targeted tests to broader syndromic panels. The news came as European healthcare systems prepare for the upcoming respiratory season.