Roche has rapidly developed and is deploying a Research Use Only (RUO) molecular PCR test for the rare Ebola Bundibugyo virus, aiming to expand testing capacity in Ituri province, Democratic Republic of Congo. This initiative comes as the country's Ebola outbreak has become the largest and deadliest in its history, with over 3,000 deaths and 6,186 confirmed cases as of September 2. The outbreak, declared a Public Health Emergency of International Concern on May 17, has been particularly challenging due to the Bundibugyo species, which cannot be detected by some common frontline tests, leading to delayed diagnoses and increased transmission.
The new PCR test, developed by Roche's subsidiary TIB MOLBIOL within six days of the Bundibugyo genome sequence being published, allows laboratories to swiftly establish testing capabilities. This rapid response is crucial for surveillance and containing the spread of the virus, especially given that the current outbreak's fatality rates are around 30-50% for the Bundibugyo strain. Roche is working directly with public health laboratories and authorities in the affected regions to make these vital PCR tests accessible, strengthening laboratory capacity and ensuring faster detection in line with WHO guidance.
The urgency of this expansion is underscored by the current state of the epidemic; the Africa CDC reported that 60-70% of new cases are spreading within communities, indicating that contact tracing is not effectively containing the disease. The overall death toll has surpassed 3,000, making it the second-largest Ebola outbreak globally, trailing only the 2014-2016 West African outbreak that claimed over 11,000 lives. The outbreak was formally declared on May 15, but some health officials believe it may have started as early as January, exacerbating the need for rapid diagnostic tools like Roche's PCR test. Wider use of Merck & Co.'s Ebola vaccine and Gilead Sciences Inc.'s antiviral drug is also being considered to help blunt the outbreak.
