PATH to collaborate with GlaxoSmithKline to develop a test critical to malaria care

PATH announced a US$9.13 million grant from the Bill & Melinda Gates Foundation to support the development of point-of-care diagnostics for glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency through a collaboration with GlaxoSmithKline (GSK). G6PD deficiency is a common hereditary condition that can result in severe reactions if patients are treated with 8-aminoquinolines, a type of drug used to cure Plasmodium vivax (P. vivax) malaria. The work under this grant will complement activities initially funded by the UK Department for International Development designed to accelerate access to testing for G6PD deficiency in support of radical cure of P. vivax infections.

Malaria is a deadly infectious disease spread by mosquitoes. P. vivax malaria (also known as relapsing malaria) is the most common form found in Asia and Latin America. It is especially difficult to cure because the parasite that causes the disease can lie dormant in the liver and can relapse, causing illness weeks or months after infection. Patients with this kind of malaria can, therefore, continue to spread malaria without effective treatment that completely–or radically–cures the infection by killing all parasites in the body, including those in the liver.

The only current and widely used medical treatment that provides radical cure for P. vivax is primaquine, which belongs to a class of drugs known as 8-aminoquinolines. However, these drugs can cause potentially lethal hemolytic anemia in patients with severe G6PD deficiency, a hereditary condition which commonly occurs in places where P. vivax malaria is endemic.

In some parts of the world, malaria is targeted for elimination, defined as the interruption of transmission and the reduction to zero the number of new cases of malaria in a geographic area. Eliminating P. vivax malaria is complicated in part by the inability to provide radical cure to patients diagnosed with infections, owing to the absence of a point-of-care test for G6PD deficiency.

"In order to provide patients with P. vivax malaria the best available care and accelerate elimination efforts of this disease, testing of G6PD levels must become a routine part of clinical care," says project lead Dr. Gonzalo Domingo. "However, simple and rapid tests for G6PD deficiency are not widely available. With the support of the Bill & Melinda Gates Foundation, PATH aims to advance the availability of a quality point-of-care test for G6PD deficiency to address this need."

GSK and the Medicines for Malaria Venture are collaborating in the development of tafenoquine, an investigational 8 aminoquinoline-based drug that targets P. vivax, including the form of the parasite that lies dormant in the liver. Patients should be tested for G6PD deficiency before tafenoquine is administered. PATH and GSK will collaborate to expedite the development of at least one point-of-care diagnostic test for G6PD deficiency for use in malaria-endemic countries prior to tafenoquine administration.

PATH has completed a comprehensive landscape analysis of the commercial and research marketplace to identify candidate G6PD deficiency tests for evaluation and conducted prospective comparative studies of G6PD assays. Key components of this work include evaluating demand-side readiness, strengthening the market, developing products based on target product profiles, and conducting demonstration studies.

PATH will work with GSK and diagnostic companies to accelerate the development, introduction, and scale-up of quality G6PD tests. The goal is to have at least one diagnostic test ready for launch in early 2018.

PATH works in partnership with national governments, the private sector, and global stakeholders to make a malaria-free world a reality. PATH pursues this goal by expanding the use of lifesaving tools and developing new strategies to create malaria-free communities; working to ensure a steady, affordable, and high-quality supply of drugs and diagnostics; and bringing together public- and private-sector partners to accelerate the development of malaria vaccines. Read more about PATH's work in malaria here.

Posted on November 3, 2014.