Image created by Dr. Michael J. Miller
Roche, through its subsidiary TIB MOLBIOL, has developed a Research Use Only (RUO) molecular PCR test for the rapid detection of the rare Ebola Bundibugyo virus. Created within six days of the Bundibugyo genome sequence being published, the assay is designed for use on the LightCycler® 480 Real-Time PCR System, the LightCycler® 480 Instrument II, the LightCycler® PRO System and the cobas® z 480 analyzer.
The test supports outbreak response efforts in Central and East Africa, including the Democratic Republic of Congo (DRC) and Uganda, and addresses the urgent need for early, accurate detection and surveillance of this emerging Ebola variant.
With no approved vaccines or specific treatments currently available for Bundibugyo virus disease, delays in detection can contribute to increased transmission and larger outbreaks. Rapid, accurate molecular testing is therefore a key component of effective outbreak control strategies.
The new RUO PCR assay targets the Bundibugyo virus, a rare species of Ebola. By enabling laboratories to swiftly establish testing capabilities, the assay is intended to help contain outbreaks and provide critical surveillance data to monitor any further spread.
TIB MOLBIOL’s rapid response library and assay design
TIB MOLBIOL operates at the frontline of outbreak response. The company maintains a rapid response library of 15,000 test pre-designs across a wide range of pathogens and more than 3,000 positive control materials. This extensive library, combined with expertise in oligonucleotide synthesis, enabled TIB MOLBIOL to evaluate multiple primer and probe combinations for the rare Ebola Bundibugyo virus within hours rather than weeks.
This off-the-shelf approach is supported by the immediate mobilization of TIB MOLBIOL’s workforce and facility resources as soon as outbreaks are identified. This model allows laboratories to access ready-to-use assay designs quickly, supporting faster deployment of testing during critical early phases of an outbreak.
Ahead of fully approved diagnostic availability, RUO tests are shipped directly to laboratories where they can be validated. This early access is essential for initial outbreak response, surveillance and research. Validation of a product as an in vitro diagnostic (IVD) or for emergency use can take months or even years, so RUO assays help bridge the gap between the emergence of a pathogen and the availability of fully approved diagnostic solutions.
Real-world performance evaluation using clinical samples
Using real clinical samples, the performance and specificity of the Bundibugyo assay were rapidly evaluated by TIB MOLBIOL’s network of independent reference laboratories. These evaluations provided critical real-time feedback on the assay’s ability to detect the Bundibugyo variant, supporting laboratories and public health authorities in making informed decisions about its use in outbreak settings.
Strengthening Ebola testing capacity in Africa
Roche is working directly with public health laboratories and authorities in affected regions to bring PCR testing for the Bundibugyo virus closer to the Ebola outbreak frontlines. This approach supports faster detection in line with WHO guidance to strengthen laboratory capacity and ensure rapid access to testing.
As a long-standing partner in healthcare infrastructure across the African continent, Roche leverages local partnerships and regional supply chains to make critical surveillance tools accessible to reference laboratories and public health institutions. These capabilities are particularly important during emergencies, when timely access to reliable testing can influence the trajectory of an outbreak.
Track record in rapid-response molecular diagnostics
The Bundibugyo virus test is the latest in a series of rapid-response molecular solutions for infectious diseases produced at scale by Roche. Previous responses include assays for Mpox in 2022, Covid-19 in 2020, ZIKA in 2015, Ebola (Zaire species) in 2014/15, MERS in 2012, H1N1 swine flu in 2009, H5N1 bird flu in 2005 and SARS in 2003.
Most recently, the team at TIB MOLBIOL developed and deployed an Andes virus test following a cruise ship outbreak of Hantavirus Disease. This history of rapid assay development demonstrates Roche’s and TIB MOLBIOL’s ongoing commitment to supporting global outbreak preparedness and response.
“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.”