Roche has developed a new PCR test for the rare Bundibugyo strain of Ebola just six days after the virus genome sequence became available, providing health authorities with a new surveillance tool during an ongoing outbreak in Central and East Africa. The test will serve as a first line of defence as health officials race to contain the outbreak.
Roche responds to a rare Ebola outbreak
Roche, through its subsidiary TIB MOLBIOL, developed the Research Use Only (RUO) molecular test following the emergence of the Bundibugyo virus, a rare Ebola species linked to the current outbreak in the Democratic Republic of the Congo and Uganda.
The World Health Organization declared the outbreak a Public Health Emergency of International Concern on May 17, 2026, underscoring concerns about the virus’s potential spread and the limited tools available to fight it.
Unlike the more widely known Zaire strain of Ebola, the Bundibugyo variant presents unique diagnostic challenges. According to Roche, some frontline Ebola tests may not reliably detect the strain, raising the risk of delayed diagnosis during the critical early stages of outbreak response.
The company credited TIB MOLBIOL’s outbreak preparedness infrastructure, including a library of 15,000 test pre-designs and thousands of control materials, for allowing scientists to rapidly evaluate and develop a working assay.
“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 tests fill a critical gap before formal approval
One of the biggest obstacles during emerging outbreaks is the time required to obtain full regulatory authorization for new diagnostic tools. While validated diagnostic tests can take months or years to reach approval, Research Use Only assays can be deployed much earlier to support surveillance and outbreak investigations.
Roche told Charity Journal that affected countries can import the tests through licenses issued by local health authorities, allowing qualified laboratories to begin using and validating them under existing regulatory frameworks.
“Rather than waiting for the multi-month or year-long process required for full in-vitro diagnostic or emergency use authorization, these tests are imported under specific import licenses granted by local health authorities on an as-needed basis,” the organization said.
The approach enables laboratories to establish testing capacity while regulators continue evaluating longer-term diagnostic solutions. Public health experts often view diagnostics as one of the most important tools during the early phase of an outbreak because identifying cases quickly can help health authorities isolate infections, trace contacts, and limit transmission.
Getting testing closer to the frontlines
Beyond developing the test itself, Roche says the challenge now is ensuring laboratories in affected regions can access it quickly. The company is working with public health authorities, reference laboratories, and regional partners across Africa to distribute the assay through existing healthcare infrastructure networks.
In an interview with Charity Journal, Roche noted that it is prioritizing access through public-sector channels rather than relying solely on commercial distribution pathways.
“Local partnerships and regional supply chains ensure that critical surveillance tools can be effectively accessible to the reference laboratories and public health institutions that urgently require them during this emergency,” the organization added.
The effort comes at a particularly important moment. There are currently no approved vaccines or targeted treatments specifically designed for the Bundibugyo strain, making early detection one of the strongest tools available to health authorities seeking to contain transmission.
For communities facing the outbreak, faster access to testing could mean earlier case identification, more effective surveillance, and a better chance of preventing the virus from spreading beyond affected regions.