Roche has developed a research-use-only (RUO) molecular PCR test designed to detect Ebola Bundibugyo virus, a rare and high-consequence strain driving an ongoing outbreak in the Democratic Republic of the Congo (DRC) and Uganda.
According to a press release, the assay was developed by Roche subsidiary TIB MOLBIOL and created within six days of the Bundibugyo virus genome sequence being published, according to the company. It is intended to support outbreak response efforts by enabling laboratories to establish rapid molecular testing capability for detection and surveillance.
The World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern on 17 May 2026, underscoring the urgency of strengthening diagnostic capacity in affected regions.
Rapid response diagnostic development
Roche said the accelerated development was enabled by its outbreak response infrastructure, including TIB MOLBIOL’s “rapid response” library of approximately 15,000 pre-designed tests and more than 3,000 positive control materials. This system allows for rapid evaluation of primer and probe combinations, shortening development timelines from weeks to hours in outbreak situations.
“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 in the press 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.”
Addressing diagnostic gaps in outbreak settings
According to Roche, RUO assays are shipped directly to laboratories for early validation, supporting initial outbreak response and surveillance activities before fully approved in vitro diagnostic (IVD) or emergency use authorization pathways, which can take months or years.
The company is working with public health laboratories and authorities in affected regions to expand access to PCR testing closer to outbreak “frontlines,” supporting faster detection in line with WHO guidance to strengthen laboratory capacity.
Experts have highlighted that the Bundibugyo strain can be more difficult to detect using some frontline tests, increasing the risk of delayed diagnosis at a critical stage of outbreak control.
Role of PCR in Ebola surveillance
PCR-based molecular testing has been a cornerstone of Ebola outbreak response, enabling rapid confirmation of infection and supporting containment measures such as isolation and contact tracing. Roche notes that its LightCycler® systems and related PCR platforms have previously been deployed in multiple viral outbreaks, including Ebola Zaire, COVID-19, Zika, and influenza-related emergencies.
As outbreaks continue in Central and East Africa, laboratory access to rapid, validated molecular assays remains a key factor in improving detection speed and strengthening surveillance efforts.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
