Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection

FDA-cleared PCR test detects 13 common respiratory pathogens from a single sample

SUNNYVALE, Calif., Sept. 29, 2026 /PRNewswire/ -- Cepheid, a Danaher company, announced today that it has received FDA clearance 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 individuals suspected of having respiratory tract infection with clinical signs and symptoms of respiratory tract infection, in conjunction with other clinical, epidemiological, and laboratory findings.

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; influenza viruses alone are estimated to cause between 9.3 and 41 million illnesses annually in the United States.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 stewardship strategies on a single GeneXpert® platform. From targeted testing to comprehensive syndromic assessment, 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

"The Xpert Respiratory Panel is designed to support high-acuity respiratory testing," said Dr. Connie Savor, Chief Medical Officer at Cepheid. "It helps clinicians make informed decisions by focusing on specific pathogen targets that can support timely care. 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 U.S. customers 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.

US-IVD. In Vitro Diagnostic Medical Device.

References

1. CDC Glossary of Influenza (Flu) Terms. Sept 2024.  https://www.cdc.gov/flu/glossary/index.html#heading-i 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. CDC About Estimated Flu Burden. https://www.cdc.gov/flu-burden/php/about/index.html Accessed September 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 and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

For Cepheid Media Inquiries:
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SOURCE Cepheid