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WHO prequalifies diagnostic test to minimize hemolysis from antimalarial drugs

WHO prequalifies diagnostic test to minimize hemolysis from antimalarial drugs


The World Health Organization (WHO) has prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The organization has approved STANDARD G6PD System manufactured by SD Biosensor, Inc which is a near-patient, semi-quantitative solution used to quantify the activity of the G6PD enzyme in capillary or venous whole blood.

Testing tools that can reliably differentiate between patients with G6PD activity levels above and below normal give clinicians’ vital information to help them choose the best P. vivax anti-relapse treatment regimens, such as single-dose tafenoquine and low- and high-dose primaquine.

About G6PD

G6PD deficiency is a hereditary disorder that impacts approximately 500 million people globally. Those with this condition may experience acute hemolysis due to antimalarial medicines used to prevent relapse due to Plasmodium vivax, a parasite that had approximately 9.2 million clinical cases in 2023.

Inability to assess and diagnose G6PD deficiency in malaria patients has made it challenging to implement widespread anti-relapse medication due to the related safety concerns.


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What was said

“The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries in enhancing access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Currently, no other prequalification applications are received for this type of tests. We encourage the submission 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 malaria response by reducing the number of P. vivax infections due to relapse and in turn reduce onward transmission,” said Dr Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme.

Conclusion

Prequalification of this G6PD test by WHO comes after two new tafenoquine products were prequalified in early December 2024 for the anti-relapse therapy of P. vivax malaria.

These treatments were suggested in the revised WHO malaria recommendations that were published a few days earlier in late November 2024.

According to WHO, adoption of simultaneous and synchronized processes for two crucial tasks—creating recommendations for vital health goods and managing their prequalification—is reflected in this package of measures.


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APR Team

African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.