COMPAS - New Technology for Determining the Cardiac Safety Profile of Drugs
A cutting-edge technology has been introduced to enhance the understanding of cardiac safety in the pharmaceutical industry during drug development. This innovation consists of a software called COMPAS (Comprehensive Analysis of Repolarisation Signal) and ECG Biometrics, developed by the Heart Research Follow-up Program at the University of Rochester Medical Center and iCardiac Technologies, Inc., respectively. Together, they provide advanced analytical services to support the industry in new product development. By analyzing the repolarization segment from surface ECGs, this technology offers a comprehensive set of ECG analysis services, enabling a thorough characterization of a new drug's cardiac safety profile. It includes the assessment of static and dynamic aspects of repolarization and incorporates novel investigational analytical tools available within iCardiac services to further elucidate the cardiac safety aspects of the new compound.
The user interface of this technology allows the performance of the Thorough QT test, a cardiac safety test mandated by regulatory bodies, while utilizing ECG Biometrics to minimize false negatives and false positives in identifying cardiotoxicity-causing drugs. It incorporates controls for individual patient heart rate variability, making it suitable for both fast and slow-acting compounds. The software also excels at identifying QT interval changes at lower drug plasma concentrations compared to existing methods. Leveraging algorithms developed over a nine-year period, iCardiac Technologies' software can analyze a vast number of heartbeats (approximately 90,000 beats) in a 24-hour Holter, while accounting for heart rate variability and other physiological variances.
The latest technology from iCardiac offers several potential benefits. It reduces the cost of ECG analysis in Thorough QT studies and provides a comprehensive characterization of a drug's propensity to cause dangerous arrhythmias in specific patient populations through unique ECG biomarkers. It facilitates the identification of cardiotoxicity and the assessment of arrhythmia risks based on specific ion channel abnormalities. Moreover, it enables the early and cost-effective elimination of potentially cardiotoxic compounds and rescues safe compounds from unnecessary termination based on standard QT measurements. Additionally, it enhances the marketability of approved compounds with cardiac safety concerns and adverse labeling. The technology aligns with FDA guidance for conducting "thorough QT" studies and is currently available worldwide through iCardiac Technologies at competitive pricing.
