Roche has announced the rapid development of a research-use-only (RUO) molecular polymerase chain reaction (PCR) test to detect the rare Ebola Bundibugyo virus.
The development follows a surge in cases that led the World Health Organization (WHO) to declare a Public Health Emergency of International Concern in the Democratic Republic of Congo and Uganda.
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The test was produced in six days by Roche’s subsidiary TIB MOLBIOL and is intended for use on the LightCycler 480 I & II Systems, LightCycler PRO System, and cobas z 480 analyser.
The Bundibugyo virus is a rare species of Ebola, and recent outbreaks in Central and East Africa have highlighted an urgent need for rapid, accurate diagnostic methods to support public health responses.
Roche stated that, before approval of fully validated diagnostics, its RUO assays can be dispatched directly to laboratories where they can then be validated for local use.
According to the company, formal in-vitro diagnostic (IVD) or emergency use validation can require significant time, often months or years.
TIB Molbiol developed the test using its extensive “rapid response” library, which includes 15,000 test pre-designs for a wide range of pathogens and more than 3,000 positive control materials.
The company indicates that this resource enabled it to quickly evaluate possible primer and probe combinations for the Bundibugyo virus.
Performance and specificity were tested using real clinical samples by TIB Molbiol’s network of independent reference laboratories to supply immediate feedback.
TIB Molbiol CEO Dr Marcus Droege said: “In outbreak situations, we recognise the ability to respond quickly is critical, and diagnostics are among the first vital tools needed.
“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.”
Roche is now working with public health laboratories and authorities in affected regions to support rapid access to testing.
The company’s previous RUO test releases have included assays for mpox, Covid-19, Zika, Middle East Respiratory Syndrome (MERS), and other infectious diseases.
Last month, Roche secured the CE mark for the Elecsys pTau217 blood test, developed alongside Eli Lilly, for detecting Alzheimer’s disease pathology.
