Cepheid said Tuesday its Xpert Respiratory Panel received CE marking under the European Union’s in vitro diagnostic rules, a regulatory milestone for a test designed to identify 13 respiratory pathogens. Cepheid is a Danaher company.
Cepheid’s product page lists nine viral targets, including influenza A and B, SARS-CoV-2, adenovirus, respiratory syncytial virus, seasonal coronavirus, human parainfluenza and human metapneumovirus, plus human rhinovirus/enterovirus. The four bacterial targets are Mycoplasma pneumoniae, Chlamydia pneumoniae, Bordetella parapertussis and Bordetella pertussis.
The company describes the panel as a multiplex polymerase chain reaction (PCR) test that uses a nasopharyngeal swab sample. Cepheid says the test runs on GeneXpert systems, returns results in under 60 minutes and requires less than one minute of hands-on time.
Cepheid says clinicians should consider the result alongside other clinical and laboratory information when diagnosing a suspected respiratory infection. The company says illnesses can share symptoms such as fever, cough and sore throat, and that the panel may support treatment decisions and responsible antibiotic use.
The EU’s IVDR, Regulation (EU) 2017/746, governs in vitro diagnostic medical devices. Article 18 links CE marking to a device’s conformity with the regulation. Cepheid’s announcement did not confirm availability across all markets and gave no rollout date or country list.
