By Muhammad Amaan
The World Health Organisation (WHO) has prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase deficiency, a vital tool for safely administering treatments that prevent Plasmodium vivax (P. vivax) malaria relapse.
In a statement on Wednesday, WHO highlighted that the prequalification marks a significant step in improving global access to life-saving health solutions.
The G6PD diagnostic test is crucial for ensuring safe administration of WHO-recommended therapies for P. vivax malaria, a major cause of malaria-related deaths worldwide.
Each year, malaria claims approximately 500,000 lives, with the majority of fatalities affecting children.
WHO noted that the test’s prequalification follows the earlier approval of two tafenoquine-based treatments for preventing P. vivax malaria relapse, which were included in updated WHO guidelines released in late November 2024.
“This prequalification is a part of WHO’s streamlined process for rapidly developing and approving essential health products,” the health body said.
The new system aims to expedite the introduction of crucial treatments to low- and middle-income countries, where the burden of malaria is highest.
P. vivax malaria is endemic in nearly all WHO regions except Europe, and it accounted for an estimated 9.2 million cases in 2023.
It is the second most common malaria parasite globally, especially outside sub-Saharan Africa.
G6PD deficiency, a genetic condition affecting more than 500 million people worldwide, can lead to acute haemolysis (destruction of red blood cells) if certain drugs used to prevent malaria relapse are administered.
The prequalification of the G6PD test addresses a critical barrier to the safe use of effective anti-relapse treatments.
WHO Assistant Director-General for Access to Medicines and Health Products, Yukiko Nakatani, explained that the prequalification would help countries increase access to quality-assured tests, enabling safer and more effective malaria treatment.
She added that no other applications for prequalification of this type of diagnostic test had been received so far.
“Currently, no other prequalification applications are received for this type of tests,” she said.
The Director of WHO’s Global Malaria Programme, Daniel Madandi, encouraged the submission of additional products to expand the range of diagnostic tools available to countries.
Madandi said wider availability of the test can strengthen global malaria response by reducing P. vivax relapses and onward transmission.
The Standard G6PD System diagnostic tool, manufactured by SD Biosensor, is a semi-quantitative, near-patient solution for measuring G6PD enzyme activity in whole blood.
The test can be used in both laboratory and non-laboratory settings, delivering results in minutes and helping clinicians select the most appropriate treatment for patients.
With this new development, WHO aims to enhance the safety and effectiveness of anti-relapse treatments for P. vivax malaria, ultimately reducing the global burden of the disease.
