The multiplex PCR test runs on existing GeneXpert systems and will begin shipping to countries that accept the CE mark in the coming weeks.
Cepheid, a Danaher company, has achieved CE marking under the in vitro medical device regulation (IVDR) for its Xpert Respiratory Panel, a multiplex PCR test that detects 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample. The test is intended to aid in diagnosing suspected infectious respiratory tract infection, in conjunction with other clinicopathological factors.
The panel runs on existing GeneXpert systems and requires less than one minute of hands-on time, according to the company. It will begin shipping to countries that accept the CE mark in the coming weeks.
“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,” says Christoph Martinaud, senior director, medical affairs EMEA at Cepheid, in a 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.”
Overlapping Symptoms Complicate Diagnosis
Common acute respiratory tract infections are often categorized as influenza-like illnesses because they present with overlapping, nonspecific symptoms such as fever, cough, and sore throat. A range of viral and bacterial pathogens can cause these illnesses, which complicates clinical assessment.
The public health burden is substantial. According to Cepheid, influenza in a typical season causes up to 50 million symptomatic cases and 15,000 to 70,000 deaths annually in the European population. Children, older adults, and immunocompromised individuals face an increased risk of complications and may require hospitalization. Specific viral infections and bacterial co-infections are also associated with greater disease severity and adverse outcomes, which underscores the value of distinguishing the underlying pathogens, the company says.
Supporting Diagnostic Stewardship on a Single Platform
Cepheid says the panel can support informed treatment decisions and responsible antibiotic use by helping clinicians identify multiple viral and bacterial respiratory infections. The company says its respiratory portfolio allows healthcare organizations to implement diagnostic stewardship strategies on a single GeneXpert system, with options ranging from targeted testing to broad syndromic panels. According to Cepheid, this approach supports patient stratification, workflow efficiency, and more effective use of healthcare resources.
Multiplex molecular testing allows 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, according to the company.
The Xpert Respiratory Panel expands a Cepheid respiratory portfolio that already includes low-plex and mid-plex options. “This clearance reflects our commitment to continuously accelerate ideas to impact, bringing meaningful diagnostic innovations to providers and patients,” says Martinaud in a release.
ID 48923653 | Respiratory Viruses © William Roberts | Dreamstime.com
