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Quantitative G6PD test

Award type :
Product Development Award
Product type :
Diagnostics
Award year :
2025
Project start date :
04 / 14 / 2025
Project end date :
11 / 14 / 2026
Project duration (months) :
19
Development stage :
Clinical Validation / Utility
Target disease :
Malaria
Region served :
World
Recipient organization / Country of funding recipient organization :
WellsBio / Republic of Korea
Collaborator(s) / Country :
University of Notre Dame / USA
Funding amount(KRW) :
148,880,858

This project aims to develop a portable, point-of-care (POC) diagnostic device to improve access to safe malaria treatment in low- and middle-income countries. G6PD deficiency—affecting over 400 million people, particularly in malaria-endemic regions—can cause severe hemolysis when patients are treated with 8-aminoquinoline drugs like primaquine or tafenoquine, which are essential for curing Plasmodium vivax malaria. Current WHO guidelines call for G6PD testing prior to treatment, yet reliable testing remains largely inaccessible in rural areas. WellsBio’s careSTART™ S1 Analyzer is designed to provide rapid, quantitative measurement of G6PD activity and hemoglobin concentration from capillary or venous blood, delivering results in just four minutes without the need for lab infrastructure or cold chain. The project will conduct clinical validation in African countries, with the device design and performance aligned to WHO prequalification requirements, ultimately enabling safer and more equitable malaria treatment at the community level.