WHO emergency use listing expands access to BIOFIRE Global Fever Panel for Ebola diagnostics

Summary: bioMérieux’s BIOFIRE^® Global Fever Special Pathogens Panel has received World Health Organization Emergency Use Listing, expanding access to rapid differential diagnostic testing for the ongoing Ebola Bundibugyo outbreak in the Democratic Republic of the Congo and neighbouring countries.

The molecular diagnostic test can detect 16 pathogens, including multiple Ebola viruses, malaria parasites, Marburg virus, West Nile virus and Lassa virus, from a single whole blood sample in approximately one hour, helping healthcare professionals identify suspected cases, guide patient management and strengthen outbreak response.

bioMérieux, a world leader in in vitro diagnostics, has announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the BIOFIRE^® Global Fever Special Pathogens Panel, strengthening access to differential diagnostic testing in support of the ongoing Ebola Bundibugyo outbreak affecting the Democratic Republic of the Congo (DRC) and neighboring countries.

The WHO listing comes as national health authorities, international organizations and local partners continue efforts to contain one of the largest outbreaks ever recorded of Ebola virus. While no specific treatment or licensed vaccine has been developed against the Bundibugyo strain, fast and accurate diagnostic testing exists and remains the first line of public health action to identify suspected cases, guide patient management, support contact tracing and help limit disease transmission.

Manufactured by BioFire Defense, LLC, a bioMérieux company, the BIOFIRE^® Global Fever Special Pathogens Panel enables healthcare professionals to simultaneously test for 16 pathogens from a single whole blood sample in approximately one hour, including multiple Ebola viruses, malaria parasites, Marburg virus, West Nile virus and Lassa virus.

By helping differentiate Ebola from other causes of acute febrile illness with similar symptoms, the panel supports faster clinical decision making and more effective use of limited healthcare resources.

The WHO Emergency Use Listing serves as an international reference providing an additional accelerated pathway for health authorities, international organizations and procurement partners to consider the panel as part of the response to the current outbreak and future preparedness efforts.

“The WHO Emergency Use Listing is an important milestone for public health preparedness and outbreak response," said Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux.

"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."

Importantly, the panel includes detection of Bundibugyo ebolavirus, the strain responsible for the current outbreak. This capability was developed years before the emergence of the current epidemic as part of BioFire Defense's long-term commitment to protecting against biothreats and emerging infectious diseases.

Supporting health authorities to reinforce diagnostics capabilities

Since the beginning of the outbreak, bioMérieux has worked alongside Ministries of Health, public health agencies and local partners to assess diagnostic needs, strengthen laboratory capacity and support deployment of testing resources across affected regions.

The company has expanded manufacturing capacity, accelerated deliveries of instruments and tests, and provided training and on-site support to laboratory professionals to help ensure rapid implementation and sustainable diagnostic capabilities.

bioMérieux has already delivered instruments and reagents to the Rwanda Biomedical Centre in June, together with training and implementation support for laboratory teams. bioMérieux also supported Uganda preparedness by delivering Instruments and reagents to the Uganda National Health Laboratory Services.

In the Democratic Republic of the Congo, bioMérieux is working with the National Institute for Biomedical Research (INRB) and health authorities to provide additional instruments and tests. These contributions are intended to complement existing diagnostic capabilities and support the use of molecular differential testing when further investigation of suspected cases is required.

"Outbreak response is about more than delivering tests," stated Vanina Laurent-Ledru Chief Public Health and Government Affairs Officer, bioMérieux. "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.”

The BIOFIRE^® Global Fever Special Pathogens Panel is FDA-cleared. It is also recommended by the U.S. Centers for Disease Control and Prevention (CDC) for response to the current outbreak.

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>