PATH and Mologic partner to advance new rapid diagnostic test for G6PD

International nonprofit organization, PATH, and UK-based test developer, Mologic, have entered into an agreement to advance a new rapid diagnostic test to support treatment and elimination of Plasmodium vivaxor relapsing malaria.

Currently, the only treatment to kill the form of P. vivax parasite that lies dormant in the liver, re-emerging to cause bouts of illness, is a class of drugs called 8-aminoquinolines, which includes primaquine. However, these drugs can cause serious side effects in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition common to areas where malaria is found.

As such, the World Health Organisation (WHO) recommends patients are tested before treatment to check if they have the condition.

PATH is advancing a portfolio of tests for G6PD deficiency that meet requirements for use in settings where P. vivaxmalaria is close to elimination. As part of this effort, PATH is working with Mologic to develop a novel qualitative point-of-care G6PD rapid diagnostic test (RDT). This new RDT has the potential to improve access to G6PD testing to support appropriate administration of primaquine. PATH and Mologic optimised the Mologic RDT for use in environmental conditions typical in malaria-endemic countries, resulting in a test that is designed for use including at the community level, where malaria is commonly diagnosed and treated.

“This test will be a significant addition to the G6PD testing options available to healthcare providers to inform case management of patients with P. vivaxmalaria,” explained Dr Gonzalo Domingo, scientific director and malaria diagnostics lead at PATH. “It will help to fill critical gaps in G6PD testing experienced by elimination programmes and will complement quantitative tests for G6PD deficiency being advanced by PATH and partners.”

“We are honoured to have developed this new rapid diagnostic test technology for G6PD deficiency that combines the direct measurement of enzyme activity into the simple lateral flow line format similar to that used in home pregnancy testing, based on Mologic’s enzyme activity detection format,” added Paul Davis, Mologiccofounder and chief scientific officer. “We would like to thank PATH for driving the development of this key test to support malaria treatment and leading efforts to bring the test to market. Mologic looks forward to continuing this partnership with PATH in advancing essential diagnostic technology to address important health issues.”

The first product variant is expected to come to market in 2019. PATH is supporting Mologic to commercialise the RDT and obtain key regulatory approvals.

Funding to PATH to support advancement of new G6PD diagnostic tools has been provided by UKAid from the UK Department for International Development and the Bill & Melinda Gates Foundation.