On December 18, 2024, the World Health Organization (WHO) prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which is crucial for the safe administration of treatments recommended by WHO to prevent relapses of Plasmodium vivax (P. vivax) malaria. This prequalification represents a significant advancement in ensuring safe and effective treatment for P. vivax malaria, highlighting WHO’s commitment to equitable access to essential health solutions worldwide. 

 

Annually, malaria claims the lives of around 500,000 individuals, predominantly children. The prequalification of the G6PD diagnostic test occurred shortly after the prequalification of two new tafenoquine products for the anti-relapse treatment of P. vivax malaria in early December. These developments were part of updated WHO malaria guidelines released in late November.

 

WHO's recent alignment of its processes for developing health product recommendations and overseeing their prequalification aims to expedite the availability of vital health products in low- and middle-income countries, enhancing global health equity.

 

P. vivax malaria is prevalent in all WHO regions except Europe, with an estimated 9.2 million clinical cases reported in 2023. G6PD deficiency, a genetic condition affecting over 500 million people, can lead to acute hemolysis when certain drugs are administered for malaria relapse prevention. The lack of accessible and reliable G6PD testing has hindered the safe provision of anti-relapse treatments, limiting their widespread use.

 

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that the prequalification of the G6PD enzyme test will enhance access to quality-assured tests, enabling safe and effective treatment for P. vivax malaria. She encouraged the submission of more products to expand the range of diagnostic tools available.

 

Dr. Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme, noted that the availability of the test could strengthen the global malaria response by reducing P. vivax infections due to relapse and, consequently, decreasing transmission rates.

 

The STANDARD G6PD System diagnostic tool, manufactured by SD Biosensor, Inc., is a semi-quantitative, near-patient solution that measures G6PD enzyme activity in blood samples. It is designed for use in both laboratory and non-laboratory settings, providing results within minutes.