Multiplex PCR Panel Gains FDA Clearance for Viral Hemorrhagic Fever Detection

As of October 31, 2026, 10,351 confirmed cases and 5,026 deaths had been reported from Ebola disease caused by Bundibugyo virus, while Lassa fever causes an estimated 100,000–300,000 infections and approximately 5,000 deaths annually in West Africa. 

Cepheid, a Danaher operating company, has received U.S. Food and Drug Administration (FDA) clearance for Xpert Hemorrhagic Fever Panel. The multiplex PCR test is designed for qualitative detection and identification of RNA from viruses that cause several viral hemorrhagic fevers. It detects and identifies nucleic acids from Ebola virus, including Zaire, Sudan, Taï Forest and Bundibugyo without differentiation, as well as Marburg virus, Lassa virus and Crimean-Congo hemorrhagic fever (CCHF) virus.

The test runs on Cepheid’s GeneXpert Dx systems and delivers results in approximately 61 minutes. Its closed-cartridge design minimizes the risk of cross-contamination between samples. The sample processing step also includes viral inactivation to support safe laboratory workflows.

In September 2026, Cepheid received World Health Organization (WHO) Emergency Use Listing for the Xpert Hemorrhagic Fever Panel. The listing enabled work with public health partners, laboratories and healthcare providers to improve diagnostic access in response to the Ebola Bundibugyo outbreak. The FDA clearance further expands the role that the GeneXpert platform can play in preparedness and response to emerging infectious disease threats. The test is an in vitro diagnostic medical device and is not available in all countries.

"When patients present symptoms that could signal a viral hemorrhagic fever, every hour matters to the patient and everyone around them. 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," said Connie Savor, Chief Medical Officer, Cepheid, a Danaher company.