South Korean in vitro diagnostics firm SD Biosensor has collaborated with the nonprofit organization PATH to advance the development and availability of new diagnostic test for malaria treatment.
The partnership has developed Standard G6PD test to guide appropriate clinical care of patients with Plasmodium vivax malaria who also have a hereditary enzyme deficiency, which can lead to severe anemia if the patient secures treatment with 8-aminoquinoline-based drugs to cure the infection.
According to PATH, Plasmodium vivax malaria is common in Asia, Latin America and Africa, and the World Health Organization (WHO) estimates two and a half billion people across the globe are at risk of infection.
WHO suggested that patients need to be tested for G6PD deficiency before radical cure is administered.
SD Biosensor’s Standard G6PD test is a handheld device, which delivers results in two minutes. It offers a quantitative measure of G6PD activity, including in heterozygous women.
Standard G6PD test utilizes a small sample of blood that is laid on a disposable strip and inserted into the reusable device, a process similar to a blood glucose meter.
The test provides a quantitative measurement of both G6PD levels and total hemoglobin, allowing health workers to determine if radical cure with an 8-aminoquinoline-based drug is appropriate for patients.
PATH malaria diagnostics lead and scientific director Dr Gonzalo Domingo said: “The STANDARD test fills a critical need by improving the ability for health care providers to determine the G6PD status of a patient when it is most needed.
“The strength of the partnership resides in SD BIOSENSOR’s commitment to making the test available and affordable for malaria-endemic settings.”
SD Biosensor secured CE mark approval for Standard G6PD test, and is presently undergoing further clinical evaluations through studies in Brazil, Ethiopia, and India.
PATH will assist and guide South Korean firm in the registration, manufacture, and sale of the new test in countries where Plasmodium vivax is endemic.