Cepheid, a Danaher company, announced that it has achieved CE marking under the in vitro medical device regulation (IVDR) for the Xpert Respiratory Panel, a multiplex PCR test designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample. The test is intended to aid in the diagnosis of suspected infectious respiratory tract infection, in conjunction with other clinicopathological factors.
Common acute respiratory tract infections are often categorized as influenza-like illnesses (ILI) because they present with overlapping, nonspecific symptoms such as fever, cough, and sore throat. These illnesses may be caused by a range of viral and bacterial pathogens, complicating clinical assessment. The public health burden is substantial; in a typical season, influenza causes substantial morbidity in the European population, with up to 50 million symptomatic cases and 15,000 to 70,000 deaths annually.
Children, older adults, and immunocompromised individuals are at increased risk for complications from respiratory infections and may require hospitalization. Additionally, specific viral infections and bacterial co-infections are associated with increased disease severity and adverse outcomes, reinforcing the importance of distinguishing the underlying pathogens to help inform clinical assessment.
By helping clinicians identify multiple viral and bacterial respiratory infections, the Xpert Respiratory Panel can support informed treatment decisions and responsible antibiotic use.
Cepheid’s respiratory portfolio enables healthcare organizations to deploy diagnostic excellence by enabling healthcare organizations to implement diagnostic stewardship strategies on a single GeneXpert system. From targeted testing to broad syndromic respiratory panels, clinicians can select the right test for the right patient at the right time, supporting patient stratification, workflow efficiency, and more effective utilization of healthcare resources.
Multiplex molecular testing enables the simultaneous detection of multiple respiratory pathogens. Published studies have shown that rapid multiplex PCR testing can reduce time to results and may support clinical management in hospital settings.
“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.”
The Xpert Respiratory Panel expands Cepheid’s respiratory portfolio, which includes low- and mid-plex options. Running on existing GeneXpert systems, the panel gives healthcare providers flexibility to select the right test for each patient.
The Xpert Respiratory Panel maintains the simplicity of existing workflows, requiring less than one minute of hands-on time while providing on-demand answers.
The test will begin shipping to countries accepting the CE mark in the coming weeks.
Cepheid, a Danaher company, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility.
Danaher is a leading global life sciences, diagnostics and biotechnology innovator committed to advancing the power of science and technology to improve human health.
