New PCR Test Targets Rare Ebola Bundibugyo Virus
Berlin, announced that it developed a Research Use Only (RUO) molecular PCR test, via its subsidiary TIB MOLBIOL, for use on the LightCycler® 480 I & II Systems, LightCycler® PRO System and the cobas® z 480 analyzer to detect the rare Ebola Bundibugyo virus. Developed within just six days as part of its 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 mobilization 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 labs, 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 guidance2 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.
This test for the Bundibugyo virus is the latest in a series of rapid-response molecular solutions for infectious diseases produced at scale by Roche, including Mpox in 2022, Covid-19 in 2020, ZIKA in 2015, Ebola (Zaire species) in 2014/15, MERS in 2012, H1N1 swine flu in 2009, H5N1 bird flu in 2005 and SARS in 2003. Most recently, the team at TIB MOLBIOL also developed and deployed an Andes virus test following the cruise ship outbreak of Hantavirus Disease.
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