The World Health Organization (WHO) has granted Emergency Use Listing (EUL) to the first molecular diagnostic test for Bundibugyo virus (BDBV), marking a significant step in strengthening global efforts to detect and contain Ebola outbreaks caused by the virus.
The newly listed test detects Bundibugyo virus by identifying its genetic material in blood samples, enabling rapid and accurate confirmation of infection.
This is expected to improve early case detection, support timely clinical care, strengthen disease surveillance and enhance outbreak response.
Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, said, “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,” she added.
The listing comes amid the largest recorded outbreak of Ebola disease caused by Bundibugyo virus. On 17 May 2026, WHO Director-General Dr Tedros Adhanom Ghebreyesus declared the outbreak a public health emergency of international concern following widespread transmission in the Democratic Republic of the Congo (DRC), with cases also reported in Uganda.
Less than two weeks after the declaration, WHO invited manufacturers of in vitro diagnostics (IVDs) for the Bundibugyo virus to submit Expressions of Interest for Emergency Use Listing.
According to WHO, the outbreak continues to expand, with 1,406 laboratory-confirmed cases and 438 deaths reported in the Democratic Republic of the Congo alone.
Laboratory testing capacity has also increased significantly through support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC). Testing has expanded from a handful of laboratories in Kinshasa and Goma, which previously had a combined capacity of around 200–400 tests per day, to a network of 10 laboratories across affected provinces capable of performing more than 2,000 tests daily.
WHO said rapid and reliable diagnosis remains essential for identifying infections early, guiding patient care, interrupting transmission and bringing outbreaks under control.
The agency added that it is continuing to work with manufacturers, governments and international partners to expand access to safe, effective and quality-assured diagnostic tools. Additional applications for Bundibugyo virus diagnostic tests submitted under the EUL pathway are currently under review.
In parallel, WHO and Africa CDC, together with partners including PATH, FIND, Clinton Health Access Initiative (CHAI) and support from Unitaid, are establishing a joint validation platform to rapidly evaluate the performance of laboratory-based molecular tests, near-point-of-care molecular tests and antigen rapid diagnostic tests.
Bundibugyo virus disease is a severe and often fatal form of Ebola caused by one of the three Ebola virus species known to trigger large outbreaks in humans. The virus can spread from infected animals to humans and then from person to person through direct contact with infected individuals, bodily fluids or contaminated surfaces.
Photo: Laboratory technicians testing samples from suspected Bundibugyo virus disease cases in Bunia, Ituri Province, Democratic Republic of the Congo. Credit: WHO / Josua Mulala Raymond
