The World Health Organization (WHO) has granted bioMérieux’s panel for detecting the Bundibugyo (BVD) virus an emergency use listing (EUL), making it the latest diagnostic to receive the designation amid an ongoing outbreak in Central Africa.
Manufactured by bioMérieux subsidiary BioFire Defense, the BioFire global fever special pathogens panel simultaneously tests for 16 pathogens, including Bundibugyo, from a single whole blood sample in approximately one hour. It can also detect other viruses including additional Ebola strains, Marburg virus, and Lassa virus. This allows clinicians to investigate several potential causes of acute febrile illness.
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With the EUL in hand, BioFire is the fifth diagnostic to receive and EUL from the WHO, with others including KH Medical’s RADIONE Ebola/Marburg detection kit and Cepheid’s GeneXpert Dx test for the detection and identification of nucleic acids of Ebola viruses.
WHO stated that the addition of BioFire “further strengthens” its EUL portfolio for emergency preparedness and response to Ebola and other viral haemorrhagic fever outbreaks.
Dr Charles Cooper, bioMérieux’s executive vice president and CMO, commented: “When an outbreak occurs, early and accurate diagnosis can make the difference between isolated cases and wider transmission. Expanding access to timely differential diagnostics helps healthcare professionals act more quickly, allocate resources more effectively and better protect communities.”
WHO accelerates Bundibugyo response
The WHO declared the current BVD outbreak a Public Health Emergency of International Concern on 17 May 2026. Since that time, various response initiatives have been set in motion. While figures fast become out of date, there have been 9,552 cases and 4,602 deaths reported in the Democratic Republic of Congo (DRC), the outbreak’s epicentre, as of 18 October.
Meanwhile, on 5 October 2026, WHO said it was informed about a “laboratory-confirmed” imported case of BVD in Kenya with travel history from the DRC. Also as of 18 October, there have been eight confirmed BVD cases in the east African country, suggesting the virus could be set for a wider spread across the continent.
There are currently no US Food and Drug Administration (FDA)-approved vaccines or antivirals for BVD, though the WHO has been accelerating R&D partnership efforts to investigate new options, alongside increasing accessibility of diagnostics to curb infection rates with its EUL protocol.
Efforts to create therapies for BVD include the WHO and international partners’ initiation of the PARTNERS trial in July 2026 to evaluate the potential of two antiviral therapies alone or in combination for treating the Ebola virus. These include Gilead Sciences’ Velkury (remdesivir), the first approved antiviral for Covid-19, and Mapp Biopharmaceutical’s investigational double antibody-based Ebola therapy, MBP134.
There is also a separate Phase I trial underway evaluating a vaccine candidate jointly developed by the University of Oxford and Pandemic Sciences Institute, though the WHO is not a direct sponsor of the trial unlike PARTNERS.
