Extensive GeneXpert® Dx system footprint across Africa enables rapid deployment of decentralized molecular testing where it is needed most

SUNNYVALE, Calif., Sept. 3, 2026 /PRNewswire/ -- Cepheid, a Danaher company and a leader in molecular diagnostics, today announced that it has received Emergency Use Listing (EUL) from the World Health Organization (WHO) for the Xpert Hemorrhagic Fever Panel test to support the diagnostic response to the Ebola Bundibugyo (BDBV) outbreak in the Democratic Republic of the Congo (DRC).

The listing enables healthcare providers and public health authorities to leverage Cepheid's rapid molecular testing technology to help identify suspected cases and support timely outbreak containment efforts. The WHO declared the outbreak a Public Health Emergency of International Concern on May 17, 2026. ¹

The Xpert Hemorrhagic Fever Panel test detects and identifies nucleic acids of the following viruses: Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo, not differentiated), as well as Crimean-Congo hemorrhagic fever (CCHF) virus, Marburg virus, and Lassa virus. The time to result is about one hour. The assay runs on Cepheid's GeneXpert Dx systems, which are widely deployed across Africa—an established infrastructure that can support rapid implementation of decentralized testing in affected regions.

"Rapid and accurate diagnostics is one of the most important tools for controlling outbreaks of highly infectious diseases such as Ebola," said Connie Savor, Cepheid's Chief Medical Officer. "With an established footprint already serving communities across Central and East Africa, we are well positioned to support healthcare providers and public healthcare authorities with timely access to reliable diagnostic information. This listing reinforces our commitment to partnering with global health organizations to expand access to critical diagnostics where and when they are needed most—and is an example of how we solve the hardest problems together."

For more than a decade, Cepheid has supported global efforts to combat Ebola. During the 2014-2016 West Africa outbreak, the Xpert^® Ebola test received FDA Emergency Use Authorization and was deployed throughout affected regions, helping expand access to rapid molecular testing.

In June 2026, Cepheid donated an initial shipment of Xpert Hemorrhagic Fever tests FDA 510(k) cleared for use by the U.S. Department of Defense and part of DoD's Next Generation Diagnostics System 2 Program² to support the response in the DRC.

The WHO EUL enables Cepheid to expand its work with public health partners, laboratories, and healthcare providers to help improve diagnostic access in affected communities.

IVD. In Vitro Diagnostic Medical Device. Not available in all countries.

Reference

1. World Health Organization. Epidemic of Ebola disease caused by Bundibyo virus… determined a public health emergency of international concern. 17 May 2026. Accessed June 2026.
2. U.S. FDA 510(k) Premarket Notification K253653. Accessed June 2026.

About Cepheid

Cepheid, a Danaher company and a leader in molecular diagnostics, 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 many of 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:
[email protected]

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SOURCE Cepheid