Roche accelerates development of rapid PCR test for Ebola Bundibugyo virus

USA—Roche has developed a research-use-only (RUO) PCR test for the rare Bundibugyo strain of the Ebola virus, providing public health authorities with a vital diagnostic tool amid ongoing outbreaks in the Democratic Republic of the Congo (DRC) and Uganda.

The test, developed through Roche subsidiary TIB Molbiol, was created in just six days after scientists published the Bundibugyo virus genome sequence.

The company said the assay is intended for use on the LightCycler 480 I & II Systems, LightCycler PRO System, and cobas z 480 analyzer, enabling laboratories to establish testing capabilities quickly during the early stages of an outbreak.

Responding to an urgent public health need

The launch comes amid growing concern over the ongoing Bundibugyo Ebola outbreak in the DRC and Uganda.

In May, the World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern, citing the increasing number of infections and the risk of further regional spread.

The Bundibugyo strain remains particularly challenging because no approved vaccine or specific treatment is currently available.

Unlike conventional diagnostic products that require extensive validation before deployment, Roche’s RUO assay can be distributed directly to laboratories for local validation and use.

The company noted that obtaining full in-vitro diagnostic (IVD) approval or emergency-use authorization often takes months or even years, making research-use assays an important first-line resource during public health emergencies.

Leveraging a rapid-response diagnostic platform

According to Roche, the accelerated development was made possible by TIB Molbiol’s extensive outbreak-response infrastructure.

The company maintains a library of approximately 15,000 pre-designed diagnostic tests covering a wide range of pathogens, along with more than 3,000 positive control materials.

This resource enabled scientists to evaluate multiple primer and probe combinations for the Bundibugyo virus within hours rather than weeks.

TIB Molbiol also mobilized its laboratory teams and manufacturing resources immediately after the outbreak was identified, significantly shortening development timelines.

To ensure reliability, the assay underwent performance and specificity testing using clinical samples analyzed through a network of independent reference laboratories.

The resulting feedback helped refine the test before deployment to affected regions.

Dr. Marcus Droege, chief executive officer of TIB Molbiol, said rapid diagnostics are among the first essential tools required during infectious disease outbreaks.

He explained that research-use assays play a vital role in the initial response phase by helping laboratories establish testing capacity, strengthen surveillance efforts, and support faster public health decision-making.

Expanding global diagnostic preparedness

Roche said it is now collaborating with public health laboratories and health authorities across affected regions to accelerate access to the new test.

The company joins a growing number of diagnostic developers working to address testing gaps identified during the Bundibugyo outbreak, which health experts say has highlighted the urgent need for fit-for-purpose diagnostic solutions.

The latest assay adds to Roche’s portfolio of outbreak-response diagnostics, which have previously included rapid test development for mpox, COVID-19, Zika virus, Middle East Respiratory Syndrome (MERS), and other emerging infectious diseases.

The announcement follows another recent milestone for the company.

Last month, Roche secured CE mark approval for the Elecsys pTau217 blood test, developed in collaboration with Eli Lilly, designed to detect Alzheimer’s disease pathology through a minimally invasive, blood-based approach.

The company has also continued to strengthen its diagnostics portfolio by advancing technologies for infectious disease screening and surveillance, reinforcing its focus on rapid detection and public health preparedness.