We leverage highly validated algorithms and keep humans involved at critical decision points. Additionally, the cost effectiveness of the highly automated studies now allows pharmaceutical companies to determine the cardiac safety of compounds earlier on in the development process.
Rochester, NY (PRWEB) January 21, 2009
iCardiac Technologies, Inc., a leader in advanced cardiac safety biomarker development, today announced that Computers in Cardiology has published an article by authors from the University of Rochester and the FDA demonstrating the use of the Highly Automated QT technology in data analysis in Thorough QT studies. The publication concludes that the Highly Automated COMPAS technology is equivalent to the costly process of manually evaluating QT measurements in all ECGs in cardiac safety studies.
The Highly Automated QT technology, which iCardiac has licensed from the University of Rochester, is unique in the industry because it combines advanced ECG signal processing with a quality assurance processes involving cardiologists. This approach improves precision and speed of data analysis while significantly reducing the analysis cost.
In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision and high cost of the "gold standard" manual QT measurements has lead to multiple efforts toward automating QT interval measurement.
The FDA, however, has not accepted fully automated QT analyses, which rely solely on computerized analysis, in cardiac safety studies. The FDA has expressed concerns that measurements provided by ECG machines are not precise enough for use in clinical trials and that even the most sophisticated algorithms cannot consistently and reliably detect the effects of an entirely novel drug on the QT interval.
Highly Automated QT technology from iCardiac combines advanced ECG signal processing algorithms developed over the past decade of electrophysiology research at the University of Rochester with a robust, human-based, quality assurance process. The technology performs a precise automated QT measurement while applying sophisticated statistical models and algorithms that guide cardiologists to those ECGs that require human attention and/or adjustment.
With this approach, only a small portion of the entire TQT (Thorough QT) dataset requires manual over-read, thereby generating significant cost savings to sponsors while at the same time providing assurance to the regulators regarding data quality.
"Highly Automated QT technology from iCardiac delivers significant cost savings without compromising the rigor of drug safety testing," said iCardiac's co-founder and Executive Vice President Sasha Latypova. "We leverage highly validated algorithms and keep humans involved at critical decision points. Additionally, the cost effectiveness of the highly automated studies now allows pharmaceutical companies to determine the cardiac safety of compounds earlier on in the development process."
Highly Automated QT analysis is part of iCardiac's software platform COMPAS 3.0. The platform provides comprehensive analysis of cardiac repolarization signals and contains several advanced arrhythmia biomarkers, as well as advanced ECG signal processing tools. COMPAS platform serves as the core technology behind the leading cardiac safety analysis services that iCardiac provides to pharmaceutical, biotech companies and clinical research organizations.
About iCardiac Technologies
iCardiac Technologies, Inc. develops and implements advanced ECG-based cardiac safety biomarkers and tools. iCardiac's advanced ECG-based cardiac safety analysis service stems from more than 30 years of research at the University of Rochester, a leading institution for ventricular arrhythmias and cardiac repolarization. iCardiac's analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement. In addition, it provides Beyond QTsm, a suite of advanced ECG-based cardiac safety markers that deliver a more accurate assessment the cardiac safety profile of drugs in development. For more information, visit: http://www.icardiac.com.