Cepheid Receives FDA Clearance for Xpert® Hemorrhagic Fever Panel Test

Original from: PR Newswire 

Cepheid, a Danaher operating company, today announced that the U.S. Food and Drug Administration (FDA) has cleared Xpert Hemorrhagic Fever Panel, a multiplex PCR test designed for the qualitative detection and identification of RNA from viruses that cause several viral hemorrhagic fevers from a single sample.

Xpert Hemorrhagic Fever Panel detects and identifies nucleic acids of the following viruses: Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo, not differentiated), as well as Marburg virus, Lassa virus, and Crimean-Congo hemorrhagic fever (CCHF) virus.

Xpert Hemorrhagic Fever Panel delivers results in approximately 61 minutes on Cepheid's GeneXpert® Dx systems. Its closed-cartridge design minimizes the risk of cross-contamination between samples, and the sample processing step includes viral inactivation to support safe laboratory workflows.

The global need remains significant. Ebola disease caused by Bundibugyo virus (BDBV) continues to spread geographically in the Democratic Republic of the Congo, Kenya, and Nigeria. As of October 31, 2026, there are 10,351 confirmed cases and 5,026 deaths reported.1 Lassa fever is estimated to cause 100,000–300,000 infections and approximately 5,000 deaths annually in West Africa while Marburg virus and Crimean-Congo hemorrhagic fever (CCHF) are estimated to cause 10,000-15,000 human infections annually.

Importantly, early symptoms of Ebola, Marburg, Lassa, and CCHF are often non-specific and difficult to distinguish from other febrile illnesses. Therefore, rapid detection can support timely patient isolation, infection prevention measures, and public health notification.

"When patients present symptoms that could signal a viral hemorrhagic fever, every hour matters to the patient and everyone around them," said Connie Savor, Chief Medical Officer, Cepheid, a Danaher company. "Xpert Hemorrhagic Fever Panel gives healthcare professionals a rapid molecular result across several high-consequence viruses from a single sample. This FDA clearance advances our commitment to making critical diagnostics accessible where and when they are needed. By accelerating ideas to impact, we're helping provide healthcare and public health teams with timely diagnostic information to support decision-making."

In September 2026, Cepheid received World Health Organization Emergency Use Listing for the Xpert Hemorrhagic Fever Panel test, enabling Cepheid to expand its work with public health partners, laboratories, and healthcare providers to improve diagnostic access in response to the Ebola Bundibugyo (BDBV) outbreak. FDA clearance further expands the role the GeneXpert platform can play in preparedness and response to emerging infectious disease threats.

Source: Cepheid Receives FDA Clearance for Xpert® Hemorrhagic Fever Panel Test