ChanTest Corporation has entered into a research collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
The overall goal of the collaboration is to improve the prediction of cardiac safety by developing new non-clinical assays, databases and computational models that can be used to assess the risk of serious cardiac events associated with drug-induced QT prolongation. The research also will seek to identify gaps in the current safety testing paradigm for new drugs.
“We are honored to be working on such a critical drug safety issue with the FDA,” said Dr. Arthur Brown, founder and Chief Scientific Officer of ChanTest. “Through this collaboration, we hope to identify and evaluate new approaches with the potential to increase the sensitivity and specificity of non-clinical electrophysiological assays.”
There is general agreement that the hERG assay, a primary means of classifying investigational drugs with the potential to prolong the QT interval, lacks sufficient sensitivity and specificity to predict the clinical risk of QT prolongation and serious ventricular arrhythmias with acceptable accuracy across all chemical and drug classes.
The collaboration will help to identify possible gaps in current safety testing while seeking to enhance an understanding of the cellular basis for serious clinical cardiac events associated with QT prolongation.