A new technology has been launched to help the pharmaceutical industry better understand the cardiac safety profile of the drugs they are developing. It consists of a software called ‘COMPAS’ (which stands for Comprehensive Analysis of Repolarisation Signal) and unique ECG Biometrics. While the COMPAS software has been developed by the Heart Research Follow-up Program, a part of University of Rochester Medical Center, the ECG Biometrics are from iCardiac Technologies, Inc. Together, they offer the industry advanced analytical services for new product development. The technology gives new insights into drug’s cardiac safety profile by providing comprehensive set of ECG analysis services and ensuring an in-depth characterization of a new drug’s cardiac safety profile based on the repolarisation segment from the surface ECGs. These investigational measurements include the analysis of static and dynamic aspects of repolarisation, and the novel investigational analytical tools are available within current iCardiac services to further elucidate the new compound’s cardiac safety aspects.
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Apart from being able to perform the Thorough QT test (a cardiac safety test that is mandated by the FDA and other regulatory bodies), the suite uses ECG Biometrics to significantly reduce "false negatives" and "false positives" while assessing which drugs cause cardiotoxicity. It has controls for heart rate variability in individual patient (instead of correcting for HR variability). This method is applicable for both slow and fast acting compounds and provides further evidence of compound safety. It also identifies QT interval changes at lower drug plasma concentrations better than current methods. The iCardiac Technologies’ software uses algorithms that have been developed over a nine-year period that are capable of analyzing all of the heartbeats contained in a 24-hour Holter (approximately 90,000 beats) while controlling for heart rate variability and other physiological variances.
iCardiac’s latest technology has several potential benefits; the most prominent being, reduced cost of ECG analysis in Thorough QT studies, rigorous characterization of a drug’s propensity to cause dangerous arrhythmias in specific patient populations through unique ECG biomarkers, characterization of cardiotoxicity and risk of arrhythmias based on specific ion channel abnormalities, earlier and more cost-effective elimination of potentially cardiotoxic compounds, ability to rescue safe compounds unnecessarily slated for termination based on standard QT measurements, ability to more effectively market already approved compounds that have cardiac safety concerns and adverse labeling, and finally compliance with the FDA guidance for conducting “thorough QT” studies. The technology is currently available on a worldwide basis through iCardiac Technologies and is competitively priced.
