The World Health Organisation (WHO) has achieved a significant milestone in the global fight against malaria by prequalifying the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.
This breakthrough promises to revolutionise the treatment of Plasmodium vivax (P. vivax) malaria by facilitating safer delivery of anti-relapse medications, such as the recently prequalified tafenoquine products.
A New Era in Malaria Treatment Malaria continues to claim an estimated 500,000 lives annually, with children disproportionately affected. P. vivax malaria, the second most common malaria strain, accounts for 9.2 million cases annually, predominantly outside sub-Saharan Africa.
The prequalification of the STANDARD G6PD System by SD Biosensor, Inc., paves the way for safer and more effective treatments, especially in regions where malaria is endemic.
Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, described the development as transformative, “The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries enhance access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria.”
The STANDARD G6PD System is designed for both laboratory and non-laboratory settings, delivering near-instant results on G6PD enzyme activity levels in the blood. Accurate diagnostics allow clinicians to tailor anti-relapse treatments, reducing the risk of acute haemolysis caused by G6PD deficiency.
Dr Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme, emphasised the broader impact, “A 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.”
WHO’s synchronised processes for product recommendations and prequalification are central to the organisation’s push for global health equity. By aligning these functions, WHO aims to reduce the time needed to introduce life-saving tools in low- and lower-middle-income countries.
As G6PD deficiency affects over 500 million people globally, the STANDARD G6PD System holds immense promise for improving malaria outcomes while expanding access to safe, effective treatments. WHO has also called on manufacturers to submit additional diagnostic tools for evaluation to ensure an even wider range of solutions.
