REGULATORY CONTEXT
Cardiotoxicity is the second leading cause of drug withdrawal after hepatotoxicity. The FDA's Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative has created a regulatory pathway for human iPSC-derived cardiomyocyte models to replace animal-based QT prolongation studies.
PLATFORM TYPES
- Heart-Chip: Emulate cardiomyocyte platform with MEA integration
- Cardiac Organoids: Self-organizing chamber-like structures
- Engineered Heart Tissue: BioPace functional cardiac constructs
- iPSC-Cardiomyocytes: CiPA-validated cell-based assays
KEY APPLICATIONS
- QT Prolongation: hERG channel and action potential testing
- Arrhythmia Risk: Proarrhythmic potential assessment
- Contractility: Inotropic and chronotropic drug effects
- Structural Cardiotoxicity: Cancer therapy-induced damage