Rapid Diagnostic Test for Malaria Antigen

Rapigen Inc. has developed a rapid diagnostic test (RDT) for malaria that accurately detects both Plasmodium falciparum and Plasmodium vivax, and addresses the critical issue of false-negative results associated with HRP2 deletion in existing RDTs. The project includes conducting clinical validations and a usability study, gathering clinical data that meets WHO Prequalification criteria through collaborative efforts in Ethiopia and Brazil.
The ultimate goal is to submit a WHO PQ dossier for RDTs that detect combined antigens of Histidine-rich protein 2 (HRP2) and parasite lactate dehydrogenase (pLDH). Achieving WHO PQ approval would enable the distribution of reliable, high-performance RDTs to low-and middle-income countries (LMICs) at affordable prices, which would significantly enhance malaria detection and treatment, leading to improved health outcomes in endemic regions.