Cepheid Gains IVDR CE Marking for 13-Pathogen Respiratory Panel

Press release summary

Cepheid said Nov. 10 that its Xpert Respiratory Panel received CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation. The multiplex PCR assay detects 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab and is designed to run on existing GeneXpert systems. Cepheid said shipments to countries accepting the CE mark are expected in the coming weeks.

The panel covers pathogens including SARS-CoV-2, influenza viruses, respiratory syncytial virus, adenovirus, rhinovirus or enterovirus, Bordetella species, Mycoplasma pneumoniae and Chlamydia pneumoniae. Cepheid reports less than one minute of hands-on preparation. Results are intended to aid diagnosis alongside clinical findings and other laboratory information.

Why it matters to laboratory readers

A broader syndromic panel on an installed GeneXpert platform may help laboratories consolidate respiratory testing and support faster triage and antimicrobial stewardship decisions. Laboratories should confirm local availability, intended-use language, reimbursement, throughput and interpretation procedures before implementation. The announcement concerns CE-marked markets and does not establish U.S. regulatory clearance.

Read the original Cepheid release.

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