Roche has announced that it developed a Research Use Only (RUO) molecular PCR test, via its subsidiary TIB MOLBIOL, to detect the rare Ebola Bundibugyo virus. The test was developed within just six days.
The PCR test is for use on the LightCycler 480 I & II Systems, LightCycler PRO System and the cobas z 480 analyzer. Created as part of Roche’s outbreak preparedness and surveillance expertise, this test supports response efforts in Central and East Africa and helps address critical needs identified during the ongoing outbreak.
The World Health Organization (WHO) declared the outbreak in the Democratic Republic of Congo (DRC) and Uganda a Public Health Emergency of International Concern on 17 May 2026.
TIB MOLBIOL is dedicated to PCR diagnostics and sits at the frontline of outbreak response, maintaining a ‘rapid response’ library of 15,000 test pre-designs across a wide range of pathogens and more than 3,000 positive control materials. This extensive library and expertise in oligonucleotide synthesis allowed TIB MOLBIOL to evaluate multiple primer and probe combinations for the rare Ebola Bundibugyo virus within hours rather than weeks. The off-the-shelf approach is also supported by the immediate mobilisation of TIB MOLBIOL's workforce and facility resources to address outbreaks as soon as they are identified.
"In outbreak situations, we recognize the ability to respond quickly is critical, and diagnostics are among the first vital tools needed," said Dr Marcus Droege, CEO of TIB MOLBIOL. "Research-use assays play a crucial role in the first phase of the outbreak response, and our focus is on working closely with laboratories to establish testing capability quickly, support surveillance and response efforts, and enable faster, more informed decision-making when it matters most."
Ahead of fully approved diagnostic availability, RUO tests are shipped directly to laboratories where they can be validated, which is essential for early-stage outbreak response, surveillance and research. Validation of a product as an in-vitro diagnostic (IVD) or for emergency use can take months or even years.
Using real clinical samples, the assay's performance and specificity for the Bundibugyo variant were expeditiously evaluated by TIB MOLBIOL's network of independent reference laboratories, providing critical real-time feedback.
Roche is now working directly with public health laboratories and authorities in affected regions to bring vital PCR testing closer to the Ebola outbreak frontlines to support faster detection in line with WHO guidance to strengthen laboratory capacity and ensure rapid testing access. As a long-standing partner in healthcare infrastructure across the African continent, Roche's local partnerships and regional supply chains ensure that critical surveillance tools can be effectively made accessible to the reference laboratories and public health institutions that urgently require them during this emergency.
Ebola is a severe and often fatal illness, with average case fatality rates of around 50%, ranging from 25% to 90% depending on the outbreak and availability of care. This current outbreak has been particularly challenging because it is caused by the rare Bundibugyo virus, which has historically been associated with fatality rates of approximately 30–50%, and can't be detected by some commonly used frontline tests. This has increased the risk of delayed diagnosis at a critical stage in the response because, with no approved vaccines or specific treatments currently available, delays in detection can contribute to increased transmission and larger outbreaks.
Ebola is caused by viruses that belong to the Orthoebolavirus genus of the filoviridae family7. Six species of Orthoebolaviruses have been identified to date, with three known to cause large outbreaks Ebola virus (EBOV) causing