Point-of-care diagnostics for G6PD deficiency, a common hereditary condition, play a critical role in supporting the appropriate treatment of Plasmodium vivax malaria
PATH and Wondfo will be partnering to create a new point-of-care (POC) glucose-6-phosphate dehydrogenase (G6PD) deficiency test using instrumentation technology and reagents developed by PATH through collaborations with pharmaceutical and diagnostics industry leaders.
The new test aims to guide the appropriate clinical care of patients with P. vivax malaria who also have a hereditary enzyme deficiency. P. vivax malaria, a disease that puts up to 2.85 billion people at risk worldwide, is mainly in Southeast Asia and Latin America. With 2 to 3 million confirmed cases globally, P. vivax is especially difficult to eliminate because the parasite can lie dormant in the liver and go on to cause relapsing and chronic illness long after the symptoms from the initial infection are resolved. Relapse prevention using a class of 8-aminoquinolines, such as primaquine and tafenoquine, is the only effective means of killing the liver form of the parasite. In patients with G6PD deficiency, however, 8-aminoquinoline drugs can lead to severe anemia, a potentially life-threatening condition. G6PD deficiency is a hereditary enzyme deficiency that affects up to 400 million people worldwide and is prevalent in places where malaria is endemic. To avoid administering 8-aminoquinoline drugs inappropriately to G6PD deficient individuals, the World Health Organization (WHO) recommends conducting a G6PD deficiency test prior to treatment.
This new partnership between Wondfo and PATH will facilitate product development and future market entry of a POC G6PD deficiency test that provides a numerical output of G6PD activity normalized for hemoglobin, thus enabling health workers to determine if radical cure with an 8-aminoquinoline-based drug is an appropriate treatment. PATH will be responsible for providing technical support and conducting laboratory evaluation of the POC G6PD test prototypes and will continue to assist in the verification, clinical validation, and commercialization of the test upon successful development.
“We are delighted to work with Wondfo, a globally recognized and fast-growing POC test developer,” states Dr. Gonzalo Domingo, Senior Scientific Director and malaria diagnostics lead in the Diagnostics Program at PATH. “After a comprehensive selection process, it became evident that Wondfo is the right partner for this project due to their product development and manufacturing capabilities, global sales and distribution networks, and mission to improve lives.”
“A low-cost POC diagnostic to test for G6PD deficiency is still needed to defeat P. vivax malaria,” states Dr. Karen Kang, CEO of Wondfo. “This collaboration between PATH and Wondfo will make it possible to provide alternative POC G6PD tests and increase supply security in the future.”
Funding to support the development of a POC G6PD test has been provided to PATH by the Bill & Melinda Gates Foundation. Development of this test will leverage development previously funded by the Bill & Melinda Gates Foundation and the Foreign, Commonwealth, and Development Office.
PATH is a global organization that works to end health inequity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including diagnostics, vaccines, drugs, devices and innovative approaches to strengthening health systems worldwide.
Wondfo is a globally recognized, fast-growing POC test leader based in China that specializes in R&D, manufacture and sales of rapid diagnostic reagents and related equipment. With more than 2000 employees, Wondfo is dedicated to making the world a better place by providing people with high quality products and services.