The research-use test was developed in six days to support surveillance and outbreak response in Central and East Africa.
Roche has developed a research-use-only (RUO) molecular PCR test to detect the rare Ebola Bundibugyo virus through its subsidiary, TIB MOLBIOL. The test was developed in six days to support response efforts in Central and East Africa following an outbreak declaration.
The World Health Organization declared the outbreak in the Democratic Republic of Congo and Uganda a Public Health Emergency of International Concern on May 17, 2026. The new assay is designed for use on the LightCycler 480 I & II Systems, LightCycler PRO System, and the cobas z 480 analyzer.
TIB MOLBIOL utilized its rapid-response library of 15,000 test pre-designs and more than 3,000 positive control materials to create the test. This library and the company’s expertise in oligonucleotide synthesis allowed for the evaluation of multiple primer and probe combinations for the Bundibugyo variant within hours.
“In outbreak situations, we recognize the ability to respond quickly is critical, and diagnostics are among the first vital tools needed,” says Marcus Droege, CEO of TIB MOLBIOL, in a release. “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.”
The Bundibugyo virus is a rare species of Ebola that has historically been associated with fatality rates of 30% to 50%. It can go undetected by some standard frontline tests, which increases the risk of delayed diagnosis and further transmission. There are currently no approved vaccines or specific treatments available for this variant.
RUO tests are shipped directly to laboratories for validation during the early stages of an outbreak. This process is essential for surveillance, response, and research, while the validation of a product as an in vitro diagnostic or for emergency use can take months or years, according to a release from the company. TIB MOLBIOL evaluated the performance and specificity of the assay using clinical samples through its network of independent reference laboratories.
Roche is working with public health laboratories and authorities in the affected regions to bring PCR testing closer to the frontlines of the outbreak. The company has previously developed rapid-response molecular solutions for other infectious diseases, including mpox, COVID-19, and the Andes virus.
During the 2014-2016 West Africa epidemic, PCR-based technologies, including Roche LightCycler systems, were used in field laboratories under Emergency Use Authorization to confirm infections and limit the spread of the virus.
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