SUNNYVALE – – November 03, 2026 -- Cepheid, a Danaher operating company, has received U.S. Food and Drug Administration clearance for the Xpert Hemorrhagic Fever Panel, a multiplex PCR test that detects four hemorrhagic fever virus groups from a single sample in approximately 61 minutes.
Single cartridge covers Ebola, Marburg, Lassa and CCHF
The panel gives qualitative detection and identification of RNA from Ebola virus, Marburg virus, Lassa virus and Crimean-Congo hemorrhagic fever (CCHF) virus. The Ebola target covers the Zaire, Sudan, Taï Forest and Bundibugyo species, which the test does not differentiate.
The test runs on Cepheid's GeneXpert Dx systems. Its closed-cartridge design limits cross-contamination between samples, and sample processing includes viral inactivation to support safe laboratory workflows.
Bundibugyo outbreak has reached 10,351 confirmed cases and 5,026 deaths
Ebola disease caused by Bundibugyo virus continues to spread in the Democratic Republic of the Congo, Kenya and Nigeria. Reported figures as of October 31, 2026 stand at 10,351 confirmed cases and 5,026 deaths.
Lassa fever causes an estimated 100,000 to 300,000 infections and about 5,000 deaths a year in West Africa. Marburg virus and CCHF together account for an estimated 10,000 to 15,000 human infections annually.
Early symptoms of all four diseases are often non-specific and hard to distinguish from other febrile illnesses. Rapid detection can support patient isolation, infection prevention and public health notification.
WHO Emergency Use Listing in September preceded the FDA decision
Cepheid received World Health Organization Emergency Use Listing for the panel in September 2026. The listing allows the company to expand work with public health partners, laboratories and healthcare providers on diagnostic access during the Bundibugyo outbreak.
Connie Savor, Cepheid's Chief Medical Officer, said "every hour matters" when patients present with symptoms that could signal a viral hemorrhagic fever. She described the panel as a rapid molecular result across several high-consequence viruses from one sample.
Cepheid said the FDA clearance extends the role of the GeneXpert platform in preparedness and response to emerging infectious disease threats. The test is an in vitro diagnostic device and is not available in all countries.