Cepheid’s 13-pathogen respiratory PCR panel earns CE marking under EU IVDR

Health systems in Europe heading into the winter respiratory season will soon have another molecular option for determining whether a patient’s illness is viral, bacterial or both. Cepheid’s Xpert Respiratory Panel, which screens a single nasopharyngeal swab for 13 pathogens, has been certified under the European Union’s (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR), the company said in a news release this week.

The multiplex polymerase chain reaction (PCR) test covers nine viruses: adenovirus, coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, human parainfluenza, influenza A, influenza B and respiratory syncytial virus, along with four bacteria: Bordetella pertussis, Bordetella parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae. Cepheid said results are meant to be weighed with a patient’s other clinical findings rather than read in isolation. Shipments to countries that recognize the CE (Conformité Européenne) mark are expected to begin within weeks.

Why pathogen-level results matter for antibiotic stewardship

Respiratory infections remain a leading source of avoidable antibiotic use in Europe. In a prospective audit of primary care across 18 European countries, general practitioners prescribed antibiotics for respiratory tract infections more frequently than considered appropriate, and prescribing rates differed sharply from one country to the next. Research published in Eurosurveillance found that community antibiotic consumption in the EU and European Economic Area had climbed back toward prepandemic levels by 2022 and exceeded 2019 levels in 13 of 27 countries. The study’s authors pointed to a resurgence of respiratory infections as one possible contributor.

Part of the problem is that a cold, the flu, COVID-19 and a bacterial infection such as whooping cough can look much the same in an exam room. Cepheid’s argument is that a single test capable of separating those causes gives clinicians a firmer basis for deciding when antibiotics are warranted. The company also cited published research indicating that rapid multiplex PCR can speed up results and may help guide patient management in hospitals.

The risks are greatest for young children, older adults and people with weakened immune systems, who are more prone to complications. Influenza by itself accounts for as many as 50 million symptomatic cases and up to 70,000 deaths in Europe annually.

How the panel fits Cepheid’s tiered GeneXpert respiratory menu

The new panel runs on existing GeneXpert instruments and takes less than a minute of hands-on time, according to Cepheid. It adds a broad syndromic option to a respiratory lineup that already includes single-target tests and mid-size panels, an arrangement the company says lets clinicians match the breadth of testing to the individual patient and use lab resources more efficiently.

Competitors have taken a similar route. QIAGEN sells a five-target QIAstat-Dx Respiratory Panel Mini alongside a 21-target Respiratory Panel Plus and has likewise pitched the pairing as a diagnostic stewardship tool. Respiratory panels made up approximately a third of the syndromic multiplex diagnostic market in 2025.

The certification also lands while diagnostic makers are still moving products onto the IVDR framework. A 2024 amendment pushed back the transition deadlines for legacy devices, with final cutoffs between the end of 2027 and the end of 2029 depending on a device’s risk class.

“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,” Christoph Martinaud, senior director of medical affairs EMEA at Cepheid, said in the news release. “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.”