NEW YORK — The World Health Organization (WHO) said Wednesday that it has prequalified a point-of-care assay that can be used to help guide the treatment of Plasmodium vivax malaria.
The Standard G6PD System, developed by South Korea's SD Biosensor in collaboration with the nonprofit organization PATH, is designed to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency, which can lead to severe anemia in patients taking 8-aminoquinoline-based drugs for P. vivax malaria.
The test is CE marked and was approved by the Australian Therapeutic Goods Administration in 2021.
The WHO's prequalification program is designed to ensure that health products for high-burden diseases meet global standards of quality, safety, and efficacy.
The WHO said the prequalification of the test comes less than a month after it prequalified two tafenoquine-based drugs from GlaxoSmithKline for the treatment of P. vivax malaria, which is also known as relapsing malaria.
"The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries in enhancing access to much-needed quality-assured tests," Yukiko Nakatani, assistant director-general for access to medicines and health products at the WHO, said in a statement. "Currently, no other prequalification applications are received for this type of tests. We encourage the submission of additional products to expand the range of effective diagnostic tools available to countries in need."