Roche develops Bundibugyo Ebola test in six days

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Roche's LightCycler PCR test
Roche

A PCR diagnostic developed by Roche for the Bundibugyo form of Ebola is being offered to health systems at the front lines of the current outbreak in central Africa.

The diagnostics giant said it developed the test within a week of the Bundibugyo genome sequence being identified, and while it is suitable only for research use at present, is being made available to laboratories to help them validate and establish their testing capacity.

The emergence of the rare Bundibugyo form of Ebola has prompted the WHO to declare the current outbreak a public health emergency of international concern, although it has scaled back some former estimates of its scale, saying some suspected cases are likely to be other infections.

The latest figures from the UN's health agency are 397 confirmed cases of the disease and 65 confirmed deaths, with a fatality rate of around 16%, and WHO Director General Tedros Adhanom Ghebreyesus has said the response is now "catching up" with the outbreak in the Democratic Republic of the Congo (DRC) and neighbouring Uganda.

He added, however, that there are still significant challenges in testing, surveillance, and vaccine development, as well as problems building community trust amid reports of attacks on teams assisting with the safe burial of people who have died from Ebola, whose bodies can remain highly infectious.

Roche said its PCR test – developed by its TIB Molbiol subsidiary – could assist with diagnostic challenges and help bring testing closer to outbreak settings where speed of response is critical to ensure effective quarantine to prevent transmission, as well as the speedy start of potentially life-saving supportive care and treatment.

That is even more important in outbreaks where there are no available vaccines or targeted treatments, and conventional control methods are the main form of defence. There are no approved medicines for Bundibugyo, although efforts are underway to accelerate the clinical development of likely candidates, including three vaccines.

PCR specialist TIB Molbiol 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, which allowed it to come up with a Bundibugyo test in just six days.

"In outbreak situations, we recognise the ability to respond quickly is critical, and diagnostics are among the first vital tools needed," said TIB Molbiol's chief executive, Dr Marcus Droege.

"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," he added.