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2nd Generation G6PD Test

Award type :
Product Development Award
Product type :
Diagnostics
Award year :
2019
Project start date :
06 / 25 / 2019
Project end date :
07 / 15 / 2022
Project duration (months) :
24 / 21
Development stage :
Late Validation, Clinical Validation
Target disease :
Malaria
Region served :
World
Recipient organization / Country of funding recipient organization :
SD Biosensor / Republic of Korea
Collaborator(s) / Country :
Program for Appropriate Technology in Health (PATH) / USA
Funding amount(KRW) :
1,199,476,560

This project improved on SD Biosensor’s first-generation quantitative POC test to screen and identify G6DP-deficient individuals, who may be at risk of severe hemolysis induced by therapeutic options for Plasmodium vivax malaria. In this project, the stability of the original product was demonstrated to be up to 24 months, thereby extending the estimated shelf-life of the product from 12 to 18 months. The product was evaluated in an endemic setting in Thailand, and a comparison of the test prototype and original showed equivalent diagnostic performance. Extension of product shelf-life will improve access to tests in remote endemic settings impacted by complex supply chain issues.