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WHO puts first molecular test for Bundibugyo virus in Emergency Use Listing: what it means

WHO puts first molecular test for Bundibugyo virus in Emergency Use Listing: what it means

Posted on July 4, 2026 By admin


The story so far 

On July 2, 2026, the World Health Organization (WHO) announced that it had added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL). The test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately. 

Why is this significant? 

On May 17, 2026, soon after local governments in Africa announced an outbreak of the Bundibugyo strain of the Ebola virus, the WHO declared a Public Health Emergency of International Concern (PHEIC) over the outbreak in the Democratic Republic of Congo (DRC), with cases spilling into Uganda. Since then, the global organisation has categorised this epidemic as the largest —and possibly most brutal — in the region.  

As of July 1, a total of 1,460 confirmed cases, including 452 deaths, have been reported from the DRC, and as of July 2, Uganda reported 20 confirmed cases, including two deaths and one person who probably died of the virus. At least 229 patients have recovered from the disease — 213 patients from the DRC and 16 patients from Uganda — while others remain on treatment. 

While Africa is no stranger to Ebola, having witnessed a few outbreaks in the past, the Bundibugyo Virus Disease (BVD) is comparatively rare, has occurred only twice before and offers challenges in terms of diagnosis and treatment. The WHO says “differentiating BVD from other endemic febrile illnesses such as malaria is challenging without laboratory confirmation using PCR or antigen/antibody-based assays”.  

So far, outbreak control has relied on rapid case identification, isolation and care, contact tracing, safe burials and strong community engagement. No approved vaccines or specific treatments also currently exist for BVD. 

What does the WHO listing mean? 

Less than two weeks after it declared the outbreak a PHEIC, the WHO called on manufacturers of in vitro diagnostics (IVD) for the Bundibugyo virus to submit Expressions of Interest for EUL. 

The WHO’s recent listing of a test for EUL brings to the table a quality-assured, emergency-cleared molecular test for Bundibugyo virus to speed up confirmation of cases during an outbreak. Rapid diagnosis, after all, is central to isolating cases, guiding treatment, improving surveillance and interrupting transmission to control outbreaks. The organisation has said the test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately. 

Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, said in a statement: “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.” 

What is the EUL procedure? 

The 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. 

It is a “risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in-vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency”. In the recent past, it was used to enlist vaccine candidates for the COVID-19 virus during the pandemic.  

The situation in Africa 

According to the WHO, it has supported, along with the Africa Centres for Disease Control and Prevention (Africa CDC), the expansion of laboratory testing capacity to a broader network of 10 laboratories across affected provinces, with a reported capacity of over 2,000 tests per day. Additional applications for the BDV IVDs submitted through the EUL procedure are currently under review. 

Meanwhile, the WHO and Africa CDC, with partners including PATH, FIND and CHAI, with support from Unitaid, are also 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 for BDV. The platform will generate critically needed clinical evidence on the performance of these products in outbreak settings, according to the WHO.  

Additionally, on July 2, 2026, a treatment trial for the Bundibugyo Ebola outbreak in the DRC enrolled its first patient. The trial, which could take months to complete and includes more than 1,000 patients, ‌will evaluate Mapp Biopharmaceutical’s experimental MBP134 antibody as a standalone treatment for Bundibugyo Ebola, as well as in combination with Gilead Sciences’ antiviral drug remdesivir, according to the WHO. 

Published – July 04, 2026 04:01 pm IST



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