WHO grants emergency listing to bioMérieux’s Ebola Bundibugyo diagnostic panel
Manufactured by BioFire Defense, a bioMérieux subsidiary, the panel tests for 16 pathogens from a single whole blood sample in approximately one hour.
DRC—The World Health Organization (WHO) has granted emergency use listing (EUL) to bioMérieux’s BioFire Global Fever Special Pathogens Panel, expanding access to diagnostic testing as the Ebola Bundibugyo outbreak spreads across Central and East Africa.
Manufactured by BioFire Defense, a bioMérieux subsidiary, the panel tests for 16 pathogens from a single whole blood sample in approximately one hour.
It targets multiple Ebola virus species, Marburg virus, Lassa virus, and malaria parasites, helping clinicians investigate several possible causes of acute febrile illness.
However, the WHO listing specifically covers detection of Bundibugyo virus.
WHO expands emergency diagnostic options
The listing adds the BioFire panel to the WHO’s emergency use portfolio for Ebola response.
Other listed diagnostics include KH Medical’s RADIONE Ebola/Marburg detection kit and Cepheid’s GeneXpert Dx test for Ebola virus nucleic acid detection.
The WHO said the addition strengthens its diagnostic portfolio for emergency preparedness and response to Ebola and other viral haemorrhagic fever outbreaks.
The EUL process assesses medical products against essential quality, safety and performance requirements to support access during public health emergencies.
Dr Charles Cooper, Executive Vice President and Chief Medical Officer at bioMérieux, said early and accurate diagnosis can help contain outbreaks.
He added that timely differential testing enables healthcare professionals to make faster clinical decisions, allocate resources more effectively and protect communities.
Bundibugyo outbreak drives demand for testing
The WHO declared the Bundibugyo virus disease outbreak a Public Health Emergency of International Concern in May 2026.
The Democratic Republic of Congo remains the outbreak’s epicentre, while Kenya has also reported outbreak-linked infections.
As of 18 October, the DRC had reported 9,552 cases and 4,602 deaths, according to figures cited in the original report.
By 20 October, Kenyan authorities had reported nine cases, highlighting the need for continued surveillance and rapid diagnosis.
The diagnostic listing comes as health authorities work to strengthen laboratory capacity and expand access to testing.
Rapid identification of suspected infections can support isolation, contact tracing and appropriate patient management, although test availability alone does not guarantee outbreak containment.
Research continues into potential treatments
No vaccine or specific antiviral treatment has been approved for Bundibugyo virus disease.
The WHO and international partners are therefore pursuing clinical research alongside efforts to improve diagnostic access.
The PARTNERS clinical trial, launched in the DRC in July 2026, is evaluating remdesivir, marketed by Gilead Sciences as Veklury, and MBP134, an investigational antibody-based therapy developed by Mapp Biopharmaceutical.
Researchers are assessing the treatments individually and in combination to determine whether they improve patient survival.
Separately, researchers are conducting a Phase I trial of a Bundibugyo vaccine candidate developed by the University of Oxford and its Pandemic Sciences Institute.
The study represents a separate research effort from the WHO-sponsored PARTNERS trial.
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