Cepheid’s haemorrhagic fever panel has become the fourth diagnostic for detecting the Bundibugyo (BVD) Ebola virus strain to receive an emergency use listing (EUL) from the World Health Organization (WHO) amid an ongoing outbreak in Central Africa.
The development means healthcare providers in the region, along with public health authorities, will be able to use Cepheid’s rapid molecular testing technology to help identify suspected BVD cases and support outbreak containment efforts.
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The WHO declared the current BVD outbreak a Public Health Emergency of International Concern on 17 May 2026, and since that time, various response initiatives have been set in motion. 6,186 cases and 3,007 deaths have been reported in the Democratic Republic of Congo (DRC), the outbreak’s epicentre, as of 31 August.
Joining three other diagnostics to receive an EUL listing, including KH Medical’s RADIONE Ebola/Marburg detection kit, Cepheid’s GeneXpert Dx test detects and identifies nucleic acids of Ebola viruses, including BVD, Zaire, and Sudan, yielding results within an hour.
Cepheid’s CMO, Connie Savor, commented: “With an established footprint already serving communities across Central and East Africa, we are well positioned to support healthcare providers and public healthcare authorities with timely access to reliable diagnostic information.
“This listing reinforces our commitment to partnering with global health organisations to expand access to critical diagnostics where and when they are needed most – and is an example of how we solve the hardest problems together.”
As there are currently no US Food and Drug Administration (FDA)-approved vaccines for BVD, the WHO has also been accelerating R&D partnership efforts to explore antiviral therapies alone or in combination for BVD treatment, as well as increasing accessibility of diagnostics to curb infection rates.
WHO, alongside international partners, initiated the PARTNERS trial in July to evaluate the potential of two antiviral therapies alone or in combination for treating BVD. These include Gilead Sciences’ Velkury (remdesivir), the first approved antiviral for Covid-19, and Mapp Biopharmaceutical’s investigational double antibody-based Ebola therapy, MBP134.
Meanwhile, the European Medicines Agency’s (EMA’s) emergency task force (ETF) is engaging with the African Medicines Agency (AMA) to plan clinical trials for potential vaccine candidates, including a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine using the ChAdOx1 modified adenovirus platform, and an mRNA vaccine. The University of Oxford is also developing the ChAdOx1 vaccine candidate, with a Phase I trial underway.
Moderna initiated a Phase I trial (NCT07737717) for its mRNA-1469 candidate in August. Designed to prevent Bundibugyo Ebola virus disease, the candidate is being developed using the company’s mRNA platform that was used to build its successful vaccine during the Covid-19 pandemic.
