The World Health Organization (WHO) has officially prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a breakthrough that could significantly improve the safe administration of treatments to prevent the relapse of Plasmodium vivax (P. vivax) malaria.
This critical prequalification, announced on 18 December 2024, comes just weeks after the WHO’s prequalification of two new tafenoquine products, which are recommended for use in the treatment of P. vivax malaria relapse.
These actions align with the WHO’s recent efforts to streamline the processes of product recommendation and prequalification, ensuring more efficient access to life-saving health solutions, particularly in low- and lower-middle-income countries.
P. vivax malaria remains a significant global health issue, with an estimated 9.2 million clinical cases in 2023 alone.
The parasite is prevalent in many parts of the world outside of sub-Saharan Africa, and while effective treatments exist, their use has been hindered by the need for G6PD testing.
G6PD deficiency is a genetic condition that affects more than 500 million people globally.
When patients with this deficiency are given certain anti-relapse medications for P. vivax, they can suffer severe side effects, including the destruction of red blood cells (hemolysis), which can be life-threatening.
The newly prequalified G6PD test will enable healthcare providers to accurately determine whether patients can safely receive anti-relapse treatments like tafenoquine or primaquine.
By identifying individuals with normal G6PD enzyme activity, clinicians can make informed decisions about which treatment regimen is safest, thus minimizing the risk of adverse reactions.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the importance of this development, stating, “The prequalification of this G6PD enzyme test can help enhance access to quality-assured tests, enabling safer and more effective malaria treatment and prevention.”
She also urged for the submission of additional diagnostic products to further expand the range of tools available to countries battling malaria.
The STANDARD G6PD System, developed by SD Biosensor, Inc., is a semi-quantitative, near-patient diagnostic tool that can deliver results within minutes.
It is designed for use in both laboratory and non-laboratory settings, increasing its accessibility for health workers in remote areas.
With this new diagnostic tool, the WHO aims to strengthen the global response to malaria by reducing the number of P. vivax relapses and, ultimately, minimizing malaria transmission.