Multiplex PCR Test Gains CE Marking to Support Respiratory Infection Diagnosis

Acute respiratory infections often present with overlapping symptoms, making it difficult to distinguish between viral and bacterial causes. Seasonal surges of influenza-like illness in Europe further increase the diagnostic burden, highlighting the need for rapid pathogen identification to guide treatment and infection control. A new CE-marked multiplex PCR test addresses this challenge by enabling detection of common respiratory pathogens from a single sample in accordance with the In Vitro Diagnostic Regulation (IVDR).

Cepheid’s Xpert Respiratory Panel has received CE marking under IVDR. The PCR test detects 13 viral and bacterial pathogens from a single nasopharyngeal swab, helping clinicians diagnose suspected respiratory tract infections alongside other clinical and laboratory findings.

Image: The panel expands Cepheid’s respiratory testing portfolio on the GeneXpert platform, offering laboratories greater flexibility in selecting tests based on clinical needs. (Photo courtesy of Cepheid)

The panel runs on existing GeneXpert systems, offering a streamlined workflow that requires less than one minute of hands-on time and delivers results on demand. It detects 13 respiratory pathogens, including adenovirus, coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, human parainfluenza virus, influenza A and B viruses, respiratory syncytial virus, Bordetella pertussis, Bordetella parapertussis, Mycoplasma pneumoniae, and Chlamydia pneumoniae. The test is classified as an in vitro diagnostic medical device, with availability varying by country.

The Xpert Respiratory Panel carries the CE-IVD mark under IVDR designation CE2797, with shipments to countries accepting CE marking expected to begin in the coming weeks. The panel expands Cepheid’s respiratory testing portfolio on the GeneXpert platform, offering laboratories greater flexibility in selecting tests based on clinical needs.

Published studies suggest that rapid multiplex PCR testing can shorten time to results and support clinical management in hospital settings. By identifying specific viral pathogens and bacterial co-infections, the panel may help guide clinical assessment, patient stratification, and diagnostic stewardship. The expanded testing menu allows clinicians to choose among targeted single-pathogen assays, mid-plex options, and broader syndromic respiratory panels on a single platform.

"As healthcare systems across Europe prepare for the upcoming respiratory season, the ability to match the right test to the right patient is more important than ever," said Christoph Martinaud, Senior Director, Medical Affairs EMEA at Cepheid.

"The Xpert Respiratory Panel further strengthens Cepheid's respiratory portfolio, enabling clinicians to choose from targeted single-pathogen tests, mid-plex panels, or broader syndromic respiratory panels on the same GeneXpert system. This clearance reflects our commitment to continuously accelerate ideas to impact, bringing meaningful diagnostic innovations to providers and patients," added Martinaud.