Cardiac Toxicology (hERG)

hERG refers to the Human Ether-a-go-go-Related Gene, responsible for the encoding of one of the potassium channel found in the heart. This channel plays a critical role in repolarizing cardiac cells, ensuring proper propagation of electrical signals throughout the myocardium.
hERG-Based Cardiac Safety Evaluation is a Predictive and Regulatory Compliant Cardiac Risk Assessment. When hERG activity is impaired, delayed repolarization can occur, leading to QT interval prolongation and an increased risk of arrhythmias, which can compromise cardiac output and progress to heart failure.

Predictive and Regulatory Compliant Cardiac Risk Assessment

Mechanistic Insights

Rapid identification of compounds with proarrhythmic potential by inhibiting hERG potassium channels, a key marker for QT interval prolongation
Determination of IC₅₀ values and calculation of safety margins relative to expected human plasma concentrations
Supports mechanistic understanding of compound-induced delayed repolarization

High-Throughput Methodology

Utilizes CHO-hERG DUO cells stably expressing hERG channels
Conducted on the qPatch Compact System, enabling semi-automated, high-throughput patch-clamp electrophysiology.
Early-stage decision support for medicinal chemistry and lead optimization

Regulatory Alignment

Aligned with ICH S7B and ICH E14 guidelines for nonclinical and clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential
Supports the “double-negative” strategy: negative hERG and in vivo QT results may waive the need for a Thorough QT (TQT) study
FDA-endorsed approach for integrated risk assessment of cardiac safety

September 29, 2025