Currently, the proarrhythmic potential of new drugs is determined by evaluating their effects on the hERG ion channel and the in vivo QT interval. However, due to the overly sensitive nature of these assays, it is believed that many potentially valuable therapeutics have been inadvertently prevented from reaching the clinic.
The comprehensive in vitro proarrhythmia assay (CiPA) is a new strategy proposed by expert working groups sponsored by the Cardiac Safety Research Consortium (CSRC), Health and Environmental Sciences Institute (HESI) and Food and Drug Administration (FDA). This proposal shifts the emphasis away from QT prolongation and focuses on predicting torsadogenic hazard through an expansion of the in vitro component of nonclinical safety evaluation.
|The Comprehensive In Vitro Proarrhythmia Assay (CiPA) Guide|
The CIPA initiative is expected to reduce unwarranted drug discovery attrition, improve accuracy in predicting cardiac risk and ultimately make better, safer drugs to benefit doctors and patients.
Our cardiac ion channel panel, SaVety™ assessment of multiple ion channel effects (MICE) and integrative human cardiomyocyte assays fulfill CiPA recommendations.