Cepheid receives FDA clearance for multiplex viral hemorrhagic fever test
The U.S. FDA has cleared Cepheid’s Xpert Hemorrhagic Fever Panel, a PCR-based test capable of detecting four major viral hemorrhagic fever pathogens in approximately 61 minutes.
Cepheid, a subsidiary of Danaher, announced that the U.S. Food and Drug Administration (FDA) has cleared its Xpert Hemorrhagic Fever Panel. The multiplex PCR test is designed to identify RNA from Ebola, Marburg, Lassa, and Crimean-Congo hemorrhagic fever viruses from a single clinical sample.
The test runs on Cepheid’s GeneXpert systems, producing results in roughly 61 minutes. To maintain safety in laboratory settings, the system utilizes a closed-cartridge design that minimizes the risk of cross-contamination and incorporates a viral inactivation step during processing.
Viral hemorrhagic fevers often present with non-specific symptoms, making clinical differentiation from other febrile illnesses difficult. By providing rapid diagnostic results, the test aims to assist healthcare providers in implementing infection control measures and patient isolation protocols sooner. "Every hour matters to the patient and everyone around them," said Connie Savor, Chief Medical Officer at Cepheid.
This regulatory milestone follows the World Health Organization’s granting of an Emergency Use Listing in September 2026. The test is intended to bolster diagnostic preparedness in regions affected by ongoing viral outbreaks.