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WHO Approves Breakthrough Diagnostic Test for Safer Malaria Treatment

The World Health Organisation (WHO) has recently prequalified a diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which is an important advancement for safely administering treatments for Plasmodium vivax malaria (P. vivax). On December 18, 2024, the WHO approved this test, making it easier to provide therapies recommended by the WHO to prevent P. vivax relapses. This milestone supports WHO’s goal to improve access to essential health solutions, especially in low- and middle-income countries, where malaria continues to be a significant public health issue. 

The action comes after two tafenoquine products were prequalified for treating P. vivax malaria in early December, and updated WHO malaria guidelines were released in late November. These actions show WHO's move towards streamlined processes for creating important health recommendations and managing their prequalification. WHO wants to make it faster to provide important health products in LMICs, showing its dedication to fairness in global health.

P. ViIn 2023, there were approximately 9.2 million clinical cases of vivax malaria in all WHO regions, with the exception of Europe.. vivax is different from other malaria strains because it can stay inactive in the liver, leading to relapses even after treatment. Tafenoquine and primaquine are effective for preventing relapses, but they can be risky for those with G6PD deficiency, a genetic condition that impacts more than 500 million people globally. People with this deficiency can experience sudden blood cell breakdown when taking specific malaria medications, making it important to have simple and reliable G6PD testing for safe treatment. 

“TIf the G6PD enzyme test is approved for people with P. vivax malaria, it can help countries get better access to quality-assured tests that are needed for safe and effective treatment and prevention of this type of relapsing malaria, said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.urrently, we are not receiving any other prequalification applications for these tests. We invite more products to be submitted to broaden the variety of useful diagnostic tools for countries that require them. 

This test will help improve global malaria control by reducing P. vivax relapses, leading to lower transmission rates. Dr. Daniel Ngamije Madandi, Director of WHO's Global Malaria Program, talked about the possible effects, saying, "More people being able to get the test can strengthen the global malaria response by stopping P. vivax infections from relapsing and then stopping further transmission." 

The STANDARD G6PD System from SD Biosensor, Inc. provides a simple, semi-quantitative way to test G6PD enzyme activity in blood samples at the point of care. The system works in labs and other places, featuring a hand-held analyser that provides results in just minutes. The test helps doctors figure out which anti-relapse drugs, such as low- and high-dose primaquine and single-dose tafenoquine, will work best for each patient by showing them which ones have normal or low G6PD activity levels. 

In LMICs, where access to effective diagnostic tools has often been restricted, the arrival of WHO-prequalified G6PD testing could bring significant changes. Lowering the risks associated with anti-relapse malaria treatments allows for the wider use of tafenoquine and primaquine, resulting in a more effective and long-lasting malaria elimination approach. 


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