WHO Prequalifies First G6PD Diagnostic Test to Enhance Safe Treatment of P. vivax Malaria

The STANDARD G6PD System, developed by SD Biosensor, Inc., is a semi-quantitative diagnostic tool designed to measure G6PD enzyme activity in blood samples.

On December 18, 2024, the World Health Organization (WHO) announced the prequalification of the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a critical step in ensuring the safe administration of treatments to prevent relapses of Plasmodium vivax (P. vivax) malaria. This breakthrough complements WHO’s earlier prequalification of two tafenoquine-based therapies in December and the release of updated malaria treatment guidelines in late November.

These synchronized milestones represent WHO’s commitment to accelerating the availability of essential health products, especially for low- and lower-middle-income countries, where malaria remains a significant public health threat.

G6PD Deficiency: A Barrier to Effective Treatment

G6PD deficiency, a genetic condition affecting over 500 million people worldwide, can lead to acute haemolysis (red blood cell destruction) when exposed to certain anti-relapse drugs for P. vivax malaria. This risk has historically limited the widespread use of these effective treatments.

The STANDARD G6PD System, developed by SD Biosensor, Inc., is a semi-quantitative diagnostic tool designed to measure G6PD enzyme activity in blood samples. It provides rapid, near-patient results using a handheld analyzer, making it suitable for both laboratory and field use.

“The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries enhance access to quality-assured tests, enabling safe and effective treatment,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

Dr. Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme, emphasized the impact of this innovation: “Wider availability of the test can help strengthen the global malaria response by reducing P. vivax infections due to relapse and in turn reducing onward transmission.”

Streamlined Processes for Faster Access

WHO’s synchronized approach to developing treatment recommendations and overseeing prequalification has significantly reduced the time required to introduce vital health products to resource-limited settings. These efforts aim to improve global health equity and accelerate access to life-saving interventions.

In addition to the diagnostic test, two new tafenoquine-based treatments—low- and high-dose regimens—were prequalified earlier in December 2024. These therapies offer more options for clinicians to tailor treatment based on G6PD activity levels, providing safer and more effective care.

P. vivax Malaria: A Persistent Global Challenge

With an estimated 9.2 million clinical cases in 2023, P. vivax malaria is endemic across all WHO regions except Europe, dominating in areas outside sub-Saharan Africa. The relapsing nature of P. vivax malaria, driven by dormant liver-stage parasites, poses unique challenges for elimination efforts.

Without accessible G6PD testing, many patients have been unable to receive anti-relapse treatments safely. The new diagnostic tool addresses this gap, empowering healthcare providers to prescribe therapies with confidence, reducing the risk of relapse, and curbing transmission.

Future Steps and Encouraging Innovation

WHO has called for additional submissions of G6PD diagnostic products to expand the range of tools available to countries in need. Dr. Nakatani highlighted the importance of diversifying the diagnostics market to ensure sustained access to quality-assured solutions.

By combining innovative diagnostic tools with effective therapies, WHO aims to accelerate progress in malaria elimination efforts, particularly in regions heavily burdened by P. vivax. These advances reflect a broader global commitment to reducing the annual toll of 500,000 malaria deaths, most of which are among children.

Key Points:

• The STANDARD G6PD System is the first WHO-prequalified diagnostic test for G6PD deficiency.
• Tafenoquine-based therapies for P. vivax malaria were also recently prequalified.
• Streamlined processes now ensure faster delivery of essential health products to low-income regions.
• Access to safe, effective anti-relapse treatments is critical to reducing malaria transmission and deaths.

With these advancements, WHO continues to lead the fight against malaria, striving for a world where no child dies from a preventable and treatable disease.