The World Health Organisation (WHO) has prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a critical tool for safely administering WHO-recommended treatments to prevent relapse of Plasmodium vivax (P. vivax) malaria.
In a statement on Wednesday, WHO emphasised that the decision reflected updated processes designed to enhance efficiency and accessibility of life-saving health solutions globally.
“The prequalification of the G6PD diagnostic test is a significant milestone in ensuring safe and effective P. vivax malaria treatment, reaffirming WHO’s commitment to equitable access to essential health solutions worldwide.
“Each year, approximately 500,000 people die from malaria, with most of the fatalities occurring among children.’”
WHO highlighted that the prequalification of this test followed closely behind the prequalification of two new tafenoquine products for anti-relapse treatment of P. vivax malaria in early December, 2024.
It said the therapeutics were recommended in the updated WHO malaria guidelines released in late November 2024.
“This streamlined process is part of WHO’s recent adoption of synchronised and parallel processes for developing recommendations for essential health products and overseeing their prequalification.
“While independent, these aligned functions aim to significantly reduce the time needed to introduce vital health products to low- and lower-middle-income countries.
“P. vivax malaria, endemic in all WHO regions except the European Region, accounted for an estimated 9.2 million clinical cases in 2023.
“P. vivax is the most common malaria parasite outside of sub-Saharan Africa.
“G6PD deficiency, a genetic condition affecting over 500 million people globally, can cause acute hemolysis (destruction of red blood cells) when certain drugs used to prevent malaria relapse are administered to those affected.
“WHO’s prequalification of the G6PD test offers a solution to the challenge of safely administering anti-relapse treatments, which has been a barrier to widespread use of this effective therapy,’’it said.
Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, stated that the prequalification of the G6PD enzyme test would help countries enhance access to quality-assured tests.
Nakatani added this would enable safe and effective treatment and prevention of relapsing malaria.
“Currently, no other prequalification applications are received for this type of tests.”
Dr Daniel Madandi, Director of WHO’s Global Malaria Programme, encouraged the submission of additional products to expand the range of diagnostic tools available to countries.
“Wider availability of the test can strengthen the global malaria response by reducing P. vivax relapses and onward transmission,” Madandi said.
The STANDARD G6PD System diagnostic tool, manufactured by SD Biosensor, Inc., is a semi-quantitative, near-patient solution designed for measuring G6PD enzyme activity in whole blood.
It is intended for use in both laboratory and non-laboratory settings and delivers results in minutes, providing critical information to clinicians in selecting the most appropriate anti-relapse treatment regimens.
Through this initiative, WHO aims to ensure safer administration of treatments for P. vivax malaria, reducing the risk of relapse and improving global health outcomes.
