WHO Lists First Molecular Test for Bundibugyo Virus on Emergency Use Listing

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The World Health Organization (WHO) has included the first molecular diagnostic test for Bundibugyo virus (BDBV) in its Emergency Use Listing (EUL), marking a critical step in enhancing rapid and accurate detection of the virus. This test identifies BDBV genetic material in blood samples, enabling swift confirmation of infections. The EUL process evaluates health products for quality, safety, and performance, ensuring they meet international standards while addressing needs in low- and middle-income countries.

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The EUL aims to accelerate access to reliable diagnostic tools, facilitating early case detection, timely clinical care, disease surveillance, and outbreak response. Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized that “timely access to quality-assured diagnostic tests can make a critical difference in containing transmission.” She highlighted the importance of balancing speed with confidence in product standards during public health emergencies.

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On 17 May 2026, WHO declared a public health emergency of international concern over an Ebola outbreak caused by BDBV in the Democratic Republic of the Congo (DRC) and Uganda. Less than two weeks later, the organization initiated a call for manufacturers of in vitro diagnostic (IVD) tests for BDBV to submit Expressions of Interest for EUL. The listing arrives as the DRC faces its largest recorded BDBV outbreak, with 1,406 laboratory-confirmed cases and 438 deaths reported as of the date of the announcement.

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Expanding laboratory testing capacity has been a priority. Initially, testing was limited to two sites—Institut National de Recherche Biomédicale in Kinshasa and Goma—with a combined daily capacity of 200–400 tests. Now, 10 laboratories across affected provinces can process over 2,000 tests per day. This expansion, supported by WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), aims to improve early case identification and outbreak control.

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WHO continues to collaborate with manufacturers, global partners, and countries to increase access to safe, effective, and quality-assured health products. Additional applications for BDBV IVDs under the EUL procedure are currently under review. Concurrently, WHO and Africa CDC, alongside partners like PATH, FIND, and CHAI, with support from Unitaid, are establishing a joint validation platform. This platform will rapidly assess diagnostic products, including molecular tests and antigen rapid tests, to generate clinical evidence on their performance in outbreak settings.

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Bundibugyo virus disease, caused by one of three Ebola virus species, is a severe, often fatal illness. Transmission occurs through contact with infected bodily fluids or contaminated surfaces. The virus can jump from animals to humans and spread between people. The WHO’s EUL for the diagnostic test is part of broader efforts to strengthen preparedness for such outbreaks.

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The EUL process ensures that diagnostic tools meet minimum international standards while addressing urgent public health needs. By prioritizing rapid deployment, the WHO aims to empower countries to respond effectively to outbreaks. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, underscored the importance of science and global cooperation in protecting health.

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As of 2026, the WHO’s mission remains focused on promoting, providing, and protecting health worldwide. The organization’s work during the BDBV outbreak reflects its commitment to equitable access to health technologies. The joint validation platform and EUL mechanism exemplify how science and collaboration can enhance outbreak response.

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The WHO’s Emergency Use Listing process has been instrumental in addressing public health emergencies. By streamlining approval for critical tools, the organization helps bridge gaps in resource-limited settings. This latest addition to the EUL underscores the importance of diagnostic innovation in controlling viral outbreaks.

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Public health emergencies demand swift, evidence-based action. The inclusion of the BDBV diagnostic test in the EUL demonstrates the WHO’s role in ensuring that health products are both effective