New PCR Assay Supports Bundibugyo Ebola Outbreak Surveillance

The current outbreaks in the Democratic Republic of the Congo and Uganda are driven by Bundibugyo virus, which some frontline tests may fail to detect. With no approved vaccines or specific treatments, timely laboratory confirmation remains critical. A new research-use PCR test now targets Bundibugyo virus to support faster detection and outbreak response.

Roche (Basel, Switzerland) has developed a Research Use Only (RUO) molecular polymerase chain reaction (PCR) assay, via its subsidiary TIB MOLBIOL, to detect the Ebola Bundibugyo virus. The assay is designed for the LightCycler 480 I & II Systems, the LightCycler PRO System, and the cobas z 480 analyzer. Development was completed within six days of the Bundibugyo genome sequence being published to enable laboratories to establish targeted testing capabilities rapidly.

TIB MOLBIOL’s rapid-response library of 15,000 assay pre-designs and more than 3,000 positive control materials enabled rapid evaluation of multiple primer and probe combinations for this variant. Using real clinical samples, a network of independent reference laboratories expeditiously assessed performance and specificity, providing real-time feedback during optimization. An off-the-shelf approach, supported by immediate mobilization of workforce and facility resources, was used to speed availability.

The test is labeled for research use only and is not for use in diagnostic procedures. Roche is working with public health laboratories and authorities in affected regions to position PCR testing closer to outbreak frontlines, in line with World Health Organization (WHO) guidance to strengthen laboratory capacity and ensure rapid testing access. RUO tests are shipped directly to laboratories where they can be validated to support early-stage outbreak response, surveillance, and research.

Ebola’s average case fatality rate is around 50% across outbreaks, while the Bundibugyo virus has historically been associated with rates of approximately 30–50%. Some commonly used frontline tests cannot detect the Bundibugyo variant, increasing the risk of delayed diagnosis when no approved vaccines or specific treatments are available. The Bundibugyo assay extends a series of rapid-response molecular solutions produced at scale for pathogens including Mpox, Covid-19, Zika, Ebola (Zaire), MERS, H1N1, H5N1, and SARS.

“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.”