FDA's Comprehensive in-vitro Proarrhythmia Assay (CiPA) Initiative

Together with a select group of pharmaceutical and biotechnology companies, we are utilizing CardioSafe 3D to participate in the FDA's Comprehensive in-vitro Proarrhythmia Assay (CiPA) initiative designed to change the landscape of nonclinical drug development by providing a more complete and accurate assessment of potential drug effects on cardiac risk through the use of stem cell-derived heart cells and in vitro ion channel data.

CiPA is a new strategy proposed by expert working groups sponsored by the U.S. Food and Drug Administration (FDA), Health and Environmental Sciences Institute (HESI) and Cardiac Safety Research Consortium (CSRC). 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 FDA's CiPA initiative is envisioned to consist of four components: (1) an evaluation of the effects of test compounds on cardiac ion channel assays; (2) in silico modeling of the cardiac action potential based on the ion channel results to integrate the data with cardiac function; (3) experimental measurement of drug effects in human ventricle myocytes to confirm the modeling results; and (4) scoring the results. The results would provide the basis for assigning a proarrhythmic score on a graduated scale, rather than a go/no-go decision.