Technological advances in the molecular diagnosis of Chagas disease from the perspective of the Fio-Chagas Translational Program

An estimated 6 to 8 million people worldwide are infected with Trypanosoma cruzi, the parasite that causes Chagas disease. Of those infected, an alarming 70 to 90% remain undiagnosed, making it one of the most hidden global health burdens. To celebrate the 25th anniversary of the Fiocruz Translational Program in Chagas Disease, Fio-Chagas, this narrative presents a chronological account of the development of PCRbased assays for the molecular detection of T. cruzi. It highlights the significant contributions made by the Fio-Chagas Translational Program to the creation and availability of a technological product for the molecular diagnosis of Chagas disease. Following the proof-of-concept, the qPCR-based Biomol Chagas kit was manufactured using reagents produced by the Institute of Molecular Biology of Paraná. After analytical and clinical validation, the kit was registered in 2022 by the Brazilian Health Surveillance Agency (ANVISA). Additional field-condition studies were required for a cost-effectiveness analysis by the National Commission for the Incorporation of Technologies into the Brazilian Unified Health System (CONITEC). Currently, the kit has been incorporated into clinical studies in Latin America to diagnose congenital transmission, monitor the impact of antiparasitic treatment in chronic Chagas disease, and evaluate oral transmission in the Northern Region of Brazil.