On Nov. 3, 2026, Cepheid announced that the U.S. FDA cleared its Xpert Hemorrhagic Fever Panel, a multiplex PCR test for detecting viral RNA from a single sample.
The panel detects Ebola virus—including Zaire, Sudan, Taï Forest and Bundibugyo species, without distinguishing between them—plus Marburg, Lassa and Crimean-Congo hemorrhagic fever viruses.
Cepheid says results are available in about 61 minutes on its GeneXpert Dx systems. The closed-cartridge design is intended to reduce cross-contamination risk, and sample processing includes viral inactivation.
The clearance follows the WHO’s Emergency Use Listing for the panel in September 2026, announced in connection with the Ebola Bundibugyo outbreak response in the Democratic Republic of the Congo.
The test is intended to aid diagnosis; results should be considered alongside clinical and other relevant information. It is not available in all countries.
Sources:
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