Cepheid's Xpert Hemorrhagic Fever Panel gets WHO approval for Ebola response

SUNNYVALE, Calif., Cepheid, a global leader in molecular diagnostics, has received Emergency Use Listing (EUL) from the World Health Organization (WHO) for its Xpert Hemorrhagic Fever Panel test. This approval, aimed at supporting the diagnostic response to the Ebola Bundibugyo (BDBV) outbreak in the Democratic Republic of the Congo (DRC), underscores Cepheid's commitment to rapid and accurate testing in high-risk areas.

The WHO declared the Ebola Bundibugyo outbreak a Public Health Emergency of International Concern on May 17, 2026. The Xpert Hemorrhagic Fever Panel test, which can detect and identify nucleic acids from Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo strains), as well as Crimean-Congo hemorrhagic fever (CCHF) virus, Marburg virus, and Lassa virus, has been cleared for use. The test can deliver results in about an hour, leveraging Cepheid's GeneXpert Dx systems, which are already well-established across Africa.

Cepheid's Chief Medical Officer, Connie Savor, emphasized the importance of rapid diagnostics in controlling highly infectious diseases: "Rapid and accurate diagnostics are critical tools in managing outbreaks like Ebola. With our extensive footprint in Central and East Africa, we are well-equipped to support healthcare providers and public health authorities with timely and reliable diagnostic information."

The company has a long history of supporting global Ebola efforts. During the 2014-2016 West Africa outbreak, Cepheid's Xpert® Ebola test received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and was deployed extensively. In June 2026, Cepheid further bolstered its support by donating an initial shipment of Xpert Hemorrhagic Fever tests, which had been cleared for use by the U.S. Department of Defense as part of the Department of Defense's Next Generation Diagnostics System 2 Program.

The WHO EUL will enable Cepheid to expand its work with public health partners, laboratories, and healthcare providers, enhancing diagnostic access in affected communities. Cepheid's GeneXpert Dx systems are widely deployed across Africa, providing a robust infrastructure for rapid implementation of decentralized testing in regions most in need.

Savor concluded, "This listing is a testament to our commitment to partnering with global health organizations to expand access to critical diagnostics. It exemplifies how we collaborate to solve the hardest problems together."

Cepheid, a Danaher company, continues to pioneer molecular diagnostics that combine speed, accuracy, and flexibility, providing actionable results wherever they are needed most, from central laboratories and hospitals to near-patient settings.