A new wave of arrhythmia assays

Cardiotoxicity testing has plagued drug developers for years as the principal preclinical test, the hERG assay, and the primary clinical marker, prolonged QT, are relatively poor predictors of proarrhythmic potential. Now, information about the different ion channels present in the heart and how their interactions with drugs affect the cardiac action potential has opened the door for a wave of new preclinical assays to assess the arrhythmia risk of candidate therapeutics.

The FDA signaled its willingness last month to embrace a new suite of preclinical assays as replacements for both potassium channel Kv11.1 (KCNH2; hERG) testing and thorough QT (tQT) clinical studies. Key stakeholders from the FDA, industry, academia and the investment space met to discuss advances in research and technology that might form the basis of the new recommendations.¹...