Roche has created a rapid molecular polymerase chain reaction test designed to detect the Bundibugyo variant of the Ebola virus. The research-use-only assay was developed by the company’s subsidiary, TIB MOLBIOL, in a six-day timeframe to assist with surveillance and response efforts in Central and East Africa.
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 diagnostic tool is intended for use on specific Roche platforms, including the LightCycler 480 I and II Systems, the LightCycler PRO System, and the cobas z 480 analyzer.
TIB MOLBIOL utilized a rapid-response library containing 15,000 test pre-designs and over 3,000 positive control materials to construct the assay. The company’s capabilities in oligonucleotide synthesis allowed for the evaluation of various primer and probe combinations for the Bundibugyo variant within hours.
Marcus Droege, chief executive officer of TIB MOLBIOL, stated that the ability to respond quickly is critical in outbreak situations and that diagnostics are among the first vital tools needed. He noted that research-use assays play a crucial role in the first phase of outbreak response and that the company focuses on working closely with laboratories to establish testing capability quickly.
The Bundibugyo virus is a rare species of Ebola historically associated with fatality rates ranging from 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.
Research-use-only 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. TIB MOLBIOL evaluated the performance and specificity of the assay using clinical samples through its network of independent reference laboratories.
