Torsade de pointes risk assessment categorization calculator based on an international multisite study of hiPSC-derived cardiomyocytes

New approach methodologies (NAMs) including human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) coupled with high-throughput platforms such as multielectrode array (MEA) and voltage-sensing optical (VSO) have proven useful for evaluating proarrhythmic risk. Despite the hiPSC-CM comprehensive in vitro proarrhythmia assay (CiPA) focus on proarrhythmic potential, risk assessment scores are not routinely included in regulatory submissions. To address this gap, we developed an open-source, web-based torsade de pointes (TdP) risk assessment categorization (TRAC) calculator utilizing the validated TdP model. The calculator employs a logistic regression model based on three hiPSC-CM compound-induced response predictors. Here, we present a JavaScript implementation of the published regression model equation. By streamlining TdP risk estimation, this tool assists the translatability of nonclinical data and provides an automated approach to evaluate compound safety. This easy-to-use online calculator based on the HESI CiPA myocyte validation TdP model enables routine use with standard laboratory devices.