Development of Next-gen Chagas DetectTM Plus Rapid test for sensitive and specific diagnosis of Chagas disease

Chagas disease (CD) is caused by Trypanosoma cruzi (T. cruzi) and transmitted by an insect (triatomine) vector, congenitally, and via blood transfusion and organ transplantation. Vector- borne transmission occurs widely in rural communities in continental Latin America, where an estimated 6 million people in 21 countries are infected. Migration from Latin America to other regions has resulted in an estimated 300,000 infected individuals in the US and tens of thousands in Europe. T. cruzi infection is life-long in the absence of successful treatment, but most infected individuals are asymptomatic and unaware of their infection. One-third of those infected develop cardiac or gastrointestinal disease decades after the acute infection. Thus, the detection of asymptomatic infected individuals is essential to enable early treatment, decrease the likelihood of chronic morbidity and prevent congenital transmission. The overall goal of this direct to Phase II project is to develop a second-generation Chagas Detect PlusTM Rapid test (CDPv2) with ≥ 97% sensitivity and ≥ 95% specificity by optimizing CDPv2 prototype performance and transitioning to manufacture. Finally, studies required for FDA 510k clearance and CLIA waiver of CDPv2 for marketing in the US and globally will be planned and conducted. The result of this Phase II award will be an FDA- cleared, CLIA waived robust point-of-care rapid test, matching the sensitivity of the original CDP while providing high specificity and operational flexibility for meeting Chagas disease testing needs in the US and beyond, within an accelerated timeline. The CDPv2 is substantially innovative in that as an FDA- cleared and CLIA-waived rapid test, it can be deployed as a stand-alone test for sero- surveillance and monitoring as well as integrated into an existing diagnostic algorithm, as needed in both endemic and non- endemic regions while pairing with the reader adds to its objectivity and utility. Our objectives for this direct to Phase II proposal will build on finalizing between the two highest performing prototypes we have generated to replace CDP and by improving performance to ≥97% sensitivity and ≥95% specificity. The down-selected prototype will then be manufactured under GMP for delivering lots that will be used for analytical and clinical studies as required by the FDA. The outcome will be an FDA- cleared CDPv2 as a replacement for CDP, but suitable for use in CLIA waived settings as well.