The multiplex PCR test returns results in about an hour from a single sample and is designed for use on GeneXpert Dx systems.
The US Food and Drug Administration (FDA) has cleared Cepheid‘s Xpert Hemorrhagic Fever Panel, a multiplex PCR test for the qualitative detection and identification of RNA from viruses that cause several viral hemorrhagic fevers, the company announced.
The panel detects Ebola virus, Marburg virus, Lassa virus, and Crimean-Congo hemorrhagic fever virus from a single sample. For Ebola, the test detects the Zaire, Sudan, Taï Forest, and Bundibugyo species but does not differentiate among them.
Results are available in approximately 61 minutes on Cepheid’s GeneXpert Dx systems. The test uses a closed-cartridge design intended to minimize the risk of cross-contamination between samples, and sample processing includes a viral inactivation step to support safe laboratory workflows, according to the company.
“When patients present symptoms that could signal a viral hemorrhagic fever, every hour matters to the patient and everyone around them,” says Connie Savor, chief medical officer, Cepheid, in a release. “Xpert Hemorrhagic Fever Panel gives healthcare professionals a rapid molecular result across several high-consequence viruses from a single sample.”
Outbreak and Disease Burden
Cepheid pointed to continuing spread of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo, Kenya, and Nigeria. Citing Associated Press reporting, the company said 10,351 confirmed cases and 5,026 deaths had been reported as of October 31, 2026.
Lassa fever is estimated to cause 100,000 to 300,000 infections and approximately 5,000 deaths annually in West Africa, according to the release. Marburg virus and Crimean-Congo hemorrhagic fever are estimated to cause 10,000 to 15,000 human infections annually.
Early symptoms of Ebola, Marburg, Lassa, and Crimean-Congo hemorrhagic fever are often nonspecific and difficult to distinguish from other febrile illnesses, the company noted, citing CDC guidance. Rapid detection can support timely patient isolation, infection prevention measures, and public health notification.
In September 2026, Cepheid received World Health Organization Emergency Use Listing for the test. The listing allows the company to expand its work with public health partners, laboratories, and healthcare providers to improve diagnostic access in response to the Bundibugyo Ebola outbreak. The FDA clearance further expands the role the GeneXpert platform can play in preparedness and response to emerging infectious disease threats, according to Cepheid.
The test is an in vitro diagnostic medical device and is not available in all countries.
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