The single-swab panel identifies 13 common viral and bacterial pathogens to help clinicians guide patient care.


RT’s Three Key Takeaways:

  1. Regulatory Clearance: Cepheid achieved CE marking under the in vitro diagnostic medical device regulation (IVDR) for its Xpert Respiratory Panel, according to a company announcement.
  2. Expanded Pathogen Detection: The molecular test detects 13 viral and bacterial respiratory pathogens from a single nasopharyngeal swab to assist in clinical management and diagnostic stewardship, the manufacturer stated.
  3. Streamlined Workflow: Running on existing GeneXpert systems, the test requires less than one minute of hands-on preparation time to generate on-demand results, according to Cepheid.


Cepheid, a Danaher company, announced today 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.

Respiratory Infections Pose Diagnostic Challenges

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.1 These illnesses may be caused by a range of viral and bacterial pathogens, complicating clinical assessment.² 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.³

Children, older adults, and immunocompromised individuals are at increased risk for complications from respiratory infections and may require hospitalization.⁴ Additionally, specific viral infections and bacterial co-infections are associated with increased disease severity and adverse outcomes,4 reinforcing the importance of distinguishing the underlying pathogens to help inform clinical assessment.

Advancing Diagnostic Excellence, Supporting Diagnostic Stewardship

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.5

Multiplex Molecular Testing Impact

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.6

“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.”

Compatible with GeneXpert Systems

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.


References

  1. EU Definition Glossary of Influenza (Flu) Terms. Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 Accessed September 2026
  2. Spencer JA et al. Distinguishing viruses responsible for influenza-like illness. J Theoret Biol Volume 545, 21 July 2022, 111145 https://www.sciencedirect.com/science/article/pii/S0022519322001436#b0430 Accessed October 2025
  3. Threat assessment brief – assessing the risks of influenza for the EU/EEA in the context of increasing circulation of A (H3N2) subclade K. Threat Assessment Brief – Assessing the risk of influenza for the EU/EEA in the context of increasing circulation of A(H3N2) subclade K Accessed October 2026
  4. Xu Y et al. Factors affecting the severity of respiratory infections: a hospital-based cross-sectional study. BMC Infect Dis. 2025;25(1):735 https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-025-11121-z Accessed October 2025
  5. Morgan DJ, Singh H, Srinivasan A, Bradford A, McDonald LC, Kutty PK. CDC’s Core Elements to promote diagnostic excellence. Diagnosis. 2025;12(2):197-200. doi:10.1515/dx-2024-0163
  6. Clark TW et al. Rapid multiplex PCR for respiratory viruses reduces time to result and improves clinical care: Results of a systematic review and meta-analysis. Journal of Infection. 2023;86(5):462-475.