The Comprehensive in vitro Proarrythmia Assay (CiPA) is an initiative intended to revise the current guidelines for evaluating a pharmaceutical drugs tendency to induce cardiac arrythmias, such as Torsade de Pointes (TdP). Current ICH guidelines in place include the S7B (non-clinical) and E14 (clinical) and have been successful in keeping these compounds out of the marketplace since the regulations began over 10 years ago.
However, these current recommendations have proved to be somewhat short-sighted, as observance of TdP is more complex than originally thought, involving several other factors. Thus, the Food and Drug Administration (FDA), Cardiac Safety Research Consortium (CSRC), and the Health and Environmental Sciences Institute (HESI) have developed a strategy for more accurately identifying potentially torsadogenic compounds in an earlier stage of drug development.
With the implementation of CiPA, several other ion channels will be similarly investigated to determine their role in inducing cardiac anomalies in the presence of a drug. These recommendations also include a broader library of cell lines in which these ion channels are expressed, including hERG, hNaV1.5, hCaV1.2, hKir2.1, and hMink. Analysis of these parameters in-vitro is indeed a more comprehensive approach and will keep potentially dangerous compounds from reaching clinical stages. The proposed timeline for the CiPA revision has been recently extended to June 2016. In the interest of CiPA compliance, AVIVA Biosciences is staying ahead of the curve to offer ion channel screening that abides by these new recommendations.
We offer the screening services on the following ion channels: