PATH partners with SD Biosensor for malaria treatment diagnostics

PATH plans to guide SD Biosensor through the registration, manufacture and sale of the test in endemic countries. (Pixabay)

International healthcare nonprofit PATH is partnering up with SD Biosensor to develop and commercialize an in vitro diagnostic that screens out patients who may have serious adverse reactions to a class of common malaria treatments.

Patients with malaria caused by Plasmodium vivax parasites—who also have a hereditary deficiency of the enzyme G6PD—can develop severe anemia if treated with drugs known as 8-aminoquinolines, including primaquine, pamaquine and GlaxoSmithKline’s investigational tafenoquine.

Known as relapsing malaria, P. vivax malaria is common in Asia, Latin America and the horn of Africa, with the World Health Organization estimating 2.5 billion people worldwide at risk of infection.

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The disease can recur and be transmitted unless patients receive treatment to kill parasites remaining in the liver, known as radical cure. The WHO recommends that patients be tested for G6PD deficiency before such treatment is administered.

According to Seattle-based PATH, currently available tests cannot adequately determine G6PD status of women who carry the gene for deficiency on only one X chromosome, and have intermediate G6PD activity levels. Other tests are too expensive or complex to use in low-resource settings where P. vivax is endemic, the organization said in a statement.

SD Biosensor, based in Suwon, South Korea, has developed a reusable handheld device similar to a blood glucose meter, which can deliver results in two minutes.

It measures total hemoglobin and G6PD activity, including in heterozygous women, to determine if the treatment is appropriate. The test is currently undergoing clinical evaluations, with results from studies in Brazil, Ethiopia and India expected by mid-2019.

PATH plans to guide SD Biosensor through the registration, manufacture and sale of the test in countries where P. vivax is endemic. With funding support from the Bill & Melinda Gates Foundation and the U.K.’s Department for International Development, PATH will work with the company to provide the test at favorable pricing terms to priority countries so that cost does not become a barrier to access.

Meanwhile, GSK, in collaboration with Medicines for Malaria Venture, submitted regulatory filings for single-dose tafenoquine at the FDA and the Australian Therapeutic Goods Administration late last year, following positive phase 3 results.

The TGA will serve as the reference authority for facilitating marketing authorizations in the Indo-Pacific region, and in countries where the disease is endemic. An FDA decision is expected in July. According to GSK, tafenoquine would be the first new medicine approved for the prevention of relapses of P. vivax malaria in more than 60 years.