Cepheid wins FDA clearance for 61-minute hemorrhagic fever panel
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.