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PATH, SD Biosensor Collaborate on Malaria Diagnostic

NEW YORK (360Dx) – Nonprofit organization PATH said on Wednesday it is partnering with SD Biosensor to further develop a diagnostic test in support of efforts to eliminate malaria.

The two entities have developed the Standard G6PD test to guide clinical care of patients with Plasmodium vivax malaria who also have a hereditary enzyme deficiency that can result in severe anemia if they are treated with 8-aminoquinoline-based drugs for the infection. The deficiency is known as glucose-6-phosphate-dehydrogenase (G6PD) deficiency.

The World Health Organization recommends patients be tested for G6PD deficiency before the start of radical treatment, PATH said, but currently available rapid tests for the condition fails to adequately determine the G6PD status of woman who carry the gene for G6PD deficiency on only one X chromosome and have intermediate G6PD activity levels.

Additionally, current tests that can sufficiently determine G6PD activity in women are too expensive and complex to be used at the point-of-care in low-resource countries where P. vivax is endemic, PATH said.

It is developing a portfolio of novel rapid tests for P. vivax that is inexpensive, simple to use, and meets specifications to improve treatment of patients and support programs to eliminate the infection. PATH is partnering with South Korea-based SD Biosensor to evaluate the Standard G6PD test for G6PD deficiency.

The test is a handheld device that provides a quantitative measurement of G6PD activity, including in heterozygous women. A small sample of blood is placed on a disposable strip and inserted into the device, similar to how a blood glucose meter is used, PATH said, adding results can be achieved in two minutes. Quantitative measurements of total hemoglobin, as well as G6PD levels, are provided, allowing health workers to determine if radical treatment with an 8-aminoquinoline-based drug is appropriate for a patient.

The CE-marked test is currently undergoing further clinical evaluations, with studies in Brazil, Ethiopia, and India expected by the middle of next year.

PATH will provide support and guidance to SD Biosensor in registering, manufacturing, and selling the test in countries where P. vivax is endemic and where the test would be most impactful. PATH will also work with SD Sensor to make the test available at favorable prices to priority countries.

PATH noted that P. vivax, sometimes called relapsing malaria, is common in Asia, Latin America, and the horn of Africa. WHO estimates that 2.5 billion people globally are at risk of being infected.

The Bill & Melinda Gates Foundation and UK Department for International Development through UKAid provided funding to support advancement of new G6PD diagnostic tools from PATH.