Cepheid Achieves CE Marking Under IVDR for Xpert® Respiratory Panel

IVDR-compliant PCR test detects 13 common respiratory pathogens from a single sample.

SUNNYVALE, Calif., Nov. 10, 2026 /PRNewswire/ -- 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.

For more information about the Xpert Respiratory Panel and Cepheid's full menu of molecular diagnostic solutions, visit www.cepheid.com.

CE-IVD. In Vitro Diagnostic Medical Device.
CE2797

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.

About Cepheid
Cepheid, a Danaher company, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. Cepheid's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

About Danaher
Danaher is a leading global life sciences, diagnostics and biotechnology innovator committed to advancing the power of science and technology to improve human health. Through a connected ecosystem of industry-leading businesses, the Company works closely with customers to solve many of their most complex scientific challenges by accelerating discovery, development and the delivery of life-changing therapies. Powered by the Danaher Business System and 60,000 associates worldwide, the Company strives for continuous improvement, operational excellence and Innovation at the Speed of Life. Explore more at www.danaher.com.

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