WHO approves G6PD diagnostic test, advancing malaria relapse prevention

The World Health Organisation (WHO) has officially prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a key tool for safely administering treatments that prevent Plasmodium vivax (P. vivax) malaria relapse.

In a statement on Wednesday, WHO emphasized that this prequalification marks a major step toward improving global access to essential health solutions. The G6PD test is vital for ensuring the safe use of WHO-recommended therapies for P. vivax malaria, a leading cause of malaria-related deaths globally.

Malaria claims about 500,000 lives annually, predominantly affecting children. WHO noted that this prequalification follows the approval of tafenoquine-based treatments for preventing P. vivax relapse, included in updated WHO guidelines released in November 2024.

“This prequalification is part of WHO’s streamlined process to rapidly develop and approve life-saving health products,” the organization stated. This new system aims to speed up the introduction of vital treatments in low- and middle-income countries, where malaria is most prevalent.

P. vivax malaria is endemic in nearly all WHO regions except Europe, and it accounted for 9.2 million cases in 2023. The parasite is the second most common globally, especially outside sub-Saharan Africa.

G6PD deficiency, a genetic disorder affecting over 500 million people worldwide, can cause hemolysis (destruction of red blood cells) when certain anti-relapse malaria treatments are administered.

The prequalification of the G6PD test overcomes a critical barrier to the safe use of these effective treatments. WHO’s Assistant Director-General for Access to Medicines and Health Products, Yukiko Nakatani, explained that the prequalification would increase access to quality-assured tests, enabling safer malaria treatment.

Currently, no other prequalification applications for similar diagnostic tests have been received. WHO’s Global Malaria Programme Director, Daniel Madandi, urged further submissions to expand diagnostic tool availability and strengthen global malaria efforts.

Manufactured by SD Biosensor, the Standard G6PD System is a semi-quantitative diagnostic tool that measures G6PD enzyme activity in whole blood. It delivers results in minutes and can be used in both laboratory and non-laboratory settings, aiding clinicians in selecting appropriate treatment.

This development will help improve the safety and effectiveness of anti-relapse therapies for P. vivax malaria, contributing to a reduction in the global malaria burden.