WHO's prequalification of the G6PD test boosts malaria treatment safety, cutting relapse and transmission risks globally.
(EPICSTORIAN) – On December 18, 2024, the World Health Organization (WHO) officially prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a critical advancement in the global efforts to manage malaria.
This diagnostic tool is key in ensuring the safe administration of treatments that prevent the relapse of Plasmodium vivax (P. vivax), a malaria parasite that continues to impact millions worldwide.
The prequalification of the G6PD diagnostic test marks a notable step in improving malaria care, especially in regions where P. vivax remains endemic. In 2023, the parasite caused approximately 9.2 million clinical cases worldwide.
Although P. vivax is not as prevalent in sub-Saharan Africa as Plasmodium falciparum, it is widespread across Southeast Asia, South America, and parts of Africa. Though treatable, P. vivax malaria often relapses, complicating its management and prolonging the disease burden.
At the core of this issue is G6PD deficiency, a genetic disorder that affects over 500 million people globally. For most individuals, the condition does not cause immediate harm, but in some cases, the administration of certain anti-relapse treatments can trigger hemolysis—destruction of red blood cells.
This can make it difficult for healthcare providers to safely use these essential therapies without a reliable diagnostic method to identify those at risk.
The prequalification of this G6PD diagnostic test is part of WHO’s broader strategy to enhance access to vital health products, particularly in low- and middle-income countries, where the availability of reliable testing and treatments is often limited.
By validating this tool, WHO aims to improve patient safety and accelerate the deployment of malaria treatments, particularly for vulnerable populations that lack access to modern healthcare infrastructure.
WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani, emphasized the importance of this development, noting, “The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries enhance access to quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria.”
She also pointed out the need for further diagnostic tools, adding, “Currently, no other prequalification applications are received for this type of tests. We encourage the submission of additional products to broaden the range of effective diagnostics for countries in need.”
The timing of this announcement coincides with the WHO’s prequalification of two new tafenoquine products, which are part of updated guidelines for preventing P. vivax relapse. This synchronized process reflects a more streamlined approach to the development and availability of essential health products, aiming to shorten the time it takes to introduce life-saving solutions to the world’s most affected regions.
Dr. Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme, stated, “Wider availability of the test can help strengthen the global malaria response by reducing the number of P. vivax infections due to relapse and, in turn, reduce onward transmission.”
The prequalified G6PD diagnostic tool, developed by SD Biosensor, Inc., is designed for use in a variety of settings, from laboratories to field locations. It measures G6PD enzyme activity in blood samples, providing results within minutes.
This near-patient solution enables healthcare providers to make quicker, more informed decisions regarding the appropriate treatment regimen for patients, including low- and high-dose primaquine and single-dose tafenoquine.
With this tool, WHO addresses a key barrier to effective malaria treatment—the need for accessible, reliable testing to avoid harmful drug reactions. The test is expected to contribute significantly to global malaria control efforts, reducing relapse rates and minimizing the transmission of the disease.
The prequalification of this G6PD diagnostic test underscores WHO’s continued focus on improving global health equity, particularly in regions heavily affected by malaria. By facilitating safer and more effective treatments, the WHO aims to reduce the impact of this deadly disease on millions of people worldwide.
