Cepheid Secures IVDR CE Marking for Xpert Respiratory Panel Detecting 13 Pathogens

Cepheid, a Danaher company, said on November 10, 2026 that it received CE marking under the In Vitro Diagnostic Medical Devices Regulation for its Xpert Respiratory Panel, a multiplex PCR test that detects 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal sample. PR Newswire published the announcement.

What the Xpert Respiratory Panel Detects

The panel identifies Adenovirus, Coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, human parainfluenza, Influenza A, Influenza B, respiratory syncytial virus, Bordetella pertussis, Bordetella parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae. Cepheid said the test is intended to aid diagnosis of a suspected respiratory infection alongside other clinical and pathological factors. Aktien reported that the test supports informed treatment decisions and antibiotic stewardship.

The panel is compatible with existing GeneXpert systems and requires less than one minute of manual handling, according to Cepheid. "Le panel respiratoire Xpert vient renforcer encore davantage l'offre de Cepheid dans le domaine des maladies respiratoires," said Christoph Martinaud, senior director of medical affairs for the EMEA region at Cepheid. Cepheid said distribution in countries that accept CE marking will begin within weeks.

Cepheid's Respiratory Revenue and Manufacturing Footprint

Cepheid is a Sunnyvale, California-based molecular diagnostics company founded in 1996 and owned by Danaher, according to akta.pro company records. The same records show Danaher reported a 25% decline in respiratory revenue at Cepheid in the first quarter of 2026. Cepheid opened a new warehouse in Lodi, California, in May 2026 and now employs over 1,500 people in the area, the same records show.

Earlier Clearances for the Same Panel

Cepheid received FDA clearance for the Xpert Respiratory Panel on September 29, 2026, according to PR Newswire. On November 3, 2026, PR Newswire reported that Cepheid received FDA clearance for its Xpert Hemorrhagic Fever Panel, a multiplex PCR test that detects Ebola, Marburg, Lassa and Crimean-Congo hemorrhagic fever viruses from a single sample. In August 2026, Infection Control Today reported that the CDC selected Cepheid as a national collaborator to speed development of rapid diagnostics for public health emergencies.

Distribution Timeline for CE-Marked Countries

Cepheid said distribution of the Xpert Respiratory Panel in countries that accept CE marking will begin within weeks of the November 10, 2026 announcement.