The molecular test can identify multiple causes of fever from a single blood sample in about an hour, helping healthcare workers diagnose infections and respond to outbreaks more quickly.
The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the BIOFIRE Global Fever Special Pathogens Panel, expanding international access to differential diagnostic testing amid an ongoing Ebola Bundibugyo outbreak affecting the Democratic Republic of the Congo (DRC) and neighboring countries.
Manufactured by BioFire Defense, a bioMérieux company, the panel enables clinical laboratories and healthcare personnel to simultaneously test for 16 pathogens from a single whole blood sample in approximately one hour. Targets include multiple Ebola viruses—including Bundibugyo ebolavirus—as well as malaria parasites, Marburg virus, West Nile virus, and Lassa virus.
Because no specific treatment or licensed vaccine currently exists for the Bundibugyo strain, rapid diagnostic confirmation serves as a primary frontline measure to confirm suspected cases, direct patient management, support contact tracing, and curb viral transmission. By distinguishing Ebola from other causes of acute febrile illness presenting with overlapping clinical symptoms, the multiplex panel assists clinicians in expediting decision-making and optimizing healthcare resources.
“The WHO Emergency Use Listing is an important milestone for public health preparedness and outbreak response,” says Dr Charles K. Cooper, executive vice president and chief medical officer, bioMérieux, in a release. “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.”
Expanding Global Diagnostics Capabilities
The WHO listing provides an accelerated procurement pathway for national health authorities, non-governmental organizations, and international procurement agencies evaluating diagnostic tools for active outbreak mitigation and future preparedness.
The BIOFIRE Global Fever Special Pathogens Panel is FDA-cleared and is also recommended by the US Centers for Disease Control and Prevention (CDC) for response efforts in the current epidemic.
In response to the regional outbreak, bioMérieux has scaled up manufacturing output, accelerated shipments of analyzers and test kits, and deployed field support and technical training for laboratory personnel. The company delivered testing systems and reagents to the Rwanda Biomedical Centre in June and supplied diagnostic materials to the Uganda National Health Laboratory Services. In the DRC, the manufacturer is collaborating with the National Institute for Biomedical Research (INRB) and local health agencies to provide supplemental systems and molecular testing supplies to assist ongoing clinical investigations.
“Outbreak response is about more than delivering tests,” says Vanina Laurent-Ledru, chief public health and government affairs officer, bioMérieux, in a release. “It requires strong partnerships, trained healthcare professionals, laboratory capacity and sustained surveillance systems. Our goal is to support health authorities not only in addressing today’s outbreak, but also in strengthening preparedness for future health threats.”
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