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WHO prequalifies diagnostic test to support safer treatment of P. vivax malaria
On December 18, 2024, the World Health Organization (WHO) requalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency that can help safely implement WHO-recommended treatments to prevent relapse Plasmodium vivax (P. vivax) infection.
The prequalification of this G6PD diagnostic test marks a significant milestone in enabling safe and effective P. vivax malaria treatment, reaffirming WHO's commitment to ensuring equitable access to life-saving health solutions globally. Approximately 500,000 people die from malaria each year, most of them children.
The pre-qualification of this test followed immediately after prequalification, at the beginning of December, of two new tafenokin products for the treatment of relapse P. vivax malaria, and these therapeutics are recommended in the updated World Health Organization Malaria Guidelines published a few days earlier, at the end of November.
This package of WHO actions reflects the recent adoption of synchronized and parallel processes for two key functions: developing recommendations for essential health products and overseeing their pre-qualification.
While these processes remain completely independent, their alignment aims to significantly reduce the time it takes to deliver vital health products to low- and lower-middle-income countries. This streamlined approach underscores WHO's commitment to improving global health equity by accelerating access to life-saving products.
P. vivax malaria is endemic in all WHO regions except the European region, with an estimated 9.2 million clinical cases occurring in 2023. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa.
G6PD deficiency, a genetic condition, affects more than 500 million people. While most people are unaware of their G6PD deficiency and go through life unharmed, certain drugs given to prevent relapse of malaria caused by P. vivax can lead to acute hemolysis (destruction of red blood cells). Without available and reliable G6PD testing, it has been challenging to provide safe treatment against relapse, limiting the widespread use of this effective therapy.
“Prequalification of this G6PD enzyme assay for patients with P. vivax malaria can help countries improve access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of malaria recurrence,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Currently, no other pre-qualification applications are being received for this type of tests. We encourage submissions of additional products to expand the range of effective diagnostic tools available to countries in need.”
“Wider availability of the test can help strengthen the global response to malaria by reducing numbers P. vivax infections due to relapse and in turn reduce further transmission,” said dr. Daniel Ngamije Madandi, Director of the WHO Global Malaria Programme.
Testing devices that can accurately distinguish between patients with G6PD activity levels above and below normal levels provide critical information for clinicians to decide which of P. vivax antirelapse regimens are most appropriate, including low- and high-dose primaquine and a single dose of tafenoquine.
Diagnostic tool STANDARD G6PD System manufactured by SD Biosensor, Inc. is a semi-quantitative near-patient solution designed to measure G6PD enzyme activity in capillary or venous whole blood. The device is intended for use in laboratory and non-laboratory settings and works with the STANDARD G6PD analyzer, a handheld device, which provides results in minutes.
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Sources 2/ https://www.who.int/news/item/08-01-2025-who-prequalifies-diagnostic-test-to-support-safer-administration-of-p.-vivax-malaria-treatments The mention sources can contact us to remove/changing this article |
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