Effective 2 July 2026, the World Health Organization (WHO) added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL), according to a WHO statement. The test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately.
What Changed: WHO Emergency Use Listing for BDBV Diagnostic
WHO’s EUL procedure assesses the quality, safety, and performance of essential health products based on the available evidence, while ensuring they meet minimum international standards and address the needs of low- and middle-income countries, the organization reported. Through this mechanism, WHO aims to accelerate access to reliable diagnostic tools for early case detection, timely clinical care, disease surveillance, and effective outbreak response. The EUL also supports United Nations procurement agencies and governments in making informed decisions about the procurement and use of these products in public health emergency settings.
Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, stated: "Public health emergencies require not only speed, but also confidence that the health products being used meet standards for quality, safety and performance. During a fast-moving outbreak, timely access to quality-assured diagnostic tests can make a critical difference in containing transmission. Through this Emergency Use Listing, WHO is helping countries access trusted diagnostic tools more rapidly so that they can respond more effectively."
Scope and Significance for Trade and Regulatory Compliance
The listing applies to the first molecular diagnostic test for BDBV, a species of Ebola virus. While the specific manufacturer of the listed test is not named in the WHO announcement, the EUL procedure is open to all manufacturers of in-vitro diagnostics (IVDs) for BDBV. WHO noted that additional applications for BDBV IVDs submitted through the EUL procedure are currently under review.
For trade compliance professionals, the EUL designation signals that the diagnostic product meets WHO quality, safety, and performance standards, which may facilitate import and export approvals in countries recognizing WHO EUL. The EUL supports UN procurement agencies and governments in procurement decisions, potentially influencing customs clearance and regulatory acceptance in emergency settings.
Compliance Obligations and Deadlines
The listing follows a WHO Director-General declaration on 17 May 2026 of a public health emergency of international concern over the outbreak of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo (DRC), with cases in Uganda. Less than two weeks later, WHO launched a call for manufacturers of IVDs for Bundibugyo virus to submit Expressions of Interest for Emergency Use Listing. Manufacturers seeking EUL for their BDBV diagnostic products must submit applications through the WHO EUL procedure, with information on active applications available on WHO webpages.
Outbreak Context and Laboratory Capacity
The listing comes at a critical time as countries respond to the largest recorded outbreak of Ebola disease caused by BDBV, which continues to expand. As of 2 July 2026, 1406 laboratory-confirmed cases and 438 deaths had been reported in the DRC alone, according to WHO. With support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), laboratory testing capacity has expanded from a limited number of sites – primarily Institut National de Recherche Biomédicale in Kinshasa and Goma, with an estimated combined capacity of approximately 200–400 tests per day – to a broader network of 10 laboratories across affected provinces, with a reported capacity of over 2000 tests per day. Rapid and reliable diagnosis remains essential to identify cases early, guide timely patient care, and help bring outbreaks under control.
Future Steps: Joint Validation Platform
In parallel, WHO and Africa CDC, with partners including PATH, FIND, and CHAI, and with support from Unitaid, are establishing a joint validation platform to rapidly evaluate the performance of a selection of diagnostic products, including laboratory-based molecular tests, near-point-of-care molecular tests, and antigen rapid diagnostic tests. The platform will generate critically needed clinical evidence on the performance of these products in outbreak settings.
Bundibugyo virus disease is a severe, often life-threatening disease caused by BDBV, one of three Ebola virus species known to cause large outbreaks in humans. The virus can spread from animals to humans and then from person to person through contact with a person sick or deceased and their infected bodily fluids or surfaces or items contaminated by these fluids.
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