en.Wedoany.com Reported - Roche has announced the rapid development of a research-use-only (RUO) molecular polymerase chain reaction (PCR) test for detecting the rare Ebola Bundibugyo virus.
Roche initiated development of the test after the World Health Organization (WHO) declared a Public Health Emergency of International Concern in the Democratic Republic of the Congo and Uganda.
The test, developed by Roche subsidiary TIB MOLBIOL in six days, is designed for use on the LightCycler 480 I and II systems, the LightCycler PRO system, and the cobas z 480 analyzer.
The Bundibugyo virus is a rare Ebola virus, and recent outbreaks in Central and East Africa have highlighted the importance of rapid, accurate diagnostic methods for public health response.
Roche stated that until a fully validated diagnostic test is approved, its RUO test can be shipped directly to laboratories, which can validate it locally for use. The company noted that formal in vitro diagnostic (IVD) or emergency use validation can take months or years.
TIB Molbiol developed the test using its "Rapid Response" library, which contains 15,000 pre-designed test items and over 3,000 positive control materials for various pathogens. The company said this resource enables it to quickly evaluate primer and probe combinations for the Bundibugyo virus.
TIB Molbiol's network of independent reference laboratories tested the performance and specificity of the test using real clinical samples to provide immediate feedback.
Dr. Marcus Droege, CEO of TIB Molbiol, stated that rapid response capability is critical in outbreak situations, and diagnostic methods are among the first key tools. Research-use tests play a crucial role in the first phase of outbreak response, and the company is working closely with laboratories to quickly establish testing capacity to support surveillance and response efforts.
Roche is currently collaborating with public health laboratories and authorities in affected regions to support rapid access to testing. The company's previously released RUO tests include those for monkeypox, Covid-19, Zika virus, Middle East Respiratory Syndrome (MERS), and other infectious diseases.
Last month, the Elecsys pTau217 blood test, co-developed by Roche and Eli Lilly, received CE marking for detecting Alzheimer's disease pathology.
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