The World Health Organization (WHO) has prequalified the first-ever diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, marking a pivotal advancement in the safe administration of treatments for Plasmodium vivax (P. vivax) malaria. This groundbreaking development ensures safer delivery of anti-relapse therapies such as tafenoquine and primaquine, both key to preventing malaria recurrence.
G6PD deficiency, a genetic condition affecting over 500 million people globally, poses a significant challenge to the widespread use of anti-relapse malaria medications. Without proper testing, certain treatments can cause acute haemolysis, a severe condition involving the destruction of red blood cells.
The STANDARD G6PD System, developed by SD Biosensor, Inc., offers a semi-quantitative, near-patient solution for detecting G6PD activity in capillary or venous blood. This portable tool delivers rapid results and is suited for both laboratory and non-laboratory settings, empowering clinicians to tailor treatment safely and effectively.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the impact of this milestone: “The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries in enhancing access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria.”
This achievement coincides with the recent WHO prequalification of two tafenoquine products for P. vivax malaria, following updated guidelines in November 2024. By synchronizing processes for developing product recommendations and prequalification, WHO aims to accelerate the availability of life-saving health solutions in low- and middle-income countries.
As P. vivax remains endemic in most regions outside sub-Saharan Africa, with over 9.2 million clinical cases reported in 2023, wider access to G6PD testing is expected to strengthen global malaria response efforts. This includes reducing infections caused by relapse and curbing onward transmission, reinforcing the fight against this relapsing malaria.
Key Highlights for Doctors:
• WHO prequalified the STANDARD G6PD System for safer malaria treatments.
• Device allows rapid and accurate testing of G6PD levels for informed clinical decisions.
• Supports safe administration of tafenoquine and primaquine in P. vivax malaria cases.
This synchronized approach reflects WHO’s commitment to improving global health equity, saving lives through innovation, and expediting access to essential diagnostic tools.
