iCardiac’s Highly Automated QTsm Technology Cross-Validated Against Results from Five Leading ECG Core Laboratories
Results Based on FDA’s ECG Data Warehouse and Shared at 2009 Drug Information Association Conference
Rochester, New York – May 11, 2009 – iCardiac Technologies, Inc., a leader in advanced cardiac safety biomarker development, today announced that the company’s Highly Automated QT technology has now been validated against manual or semi-automated measurements made by five leading ECG core laboratories. The data for the analysis comprised a total of six independent Thorough QT (TQT) studies stored in FDA’s ECG warehouse. The results of the validation study found the measurements made by Highly Automated QT to be statistically consistent with the measurements made independently and in a blinded fashion by the core laboratories.
“This is an important step for cardiac safety testing,” said Sasha Latypova, Executive Vice President at iCardiac. “Given these results, pharmaceutical companies can be confident in using the Highly Automated QT technology in their cardiac safety studies to increase the robustness of their study results, as well as to drive cost reductions in their development process.”
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 process involving cardiologists. With this approach, only a small portion of the entire Thorough QT (TQT) dataset requires manual over-reading, thereby generating significant cost and time savings to sponsors while at the same time providing assurance to the regulators regarding data quality.
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 efforts toward automating QT interval measurement.
About iCardiac Technologies
iCardiac Technologies, Inc. is a technologically differentiated cardiac core lab providing expert scientific consultation, end-to-end project management, statistical analysis and the industry’s most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac’s analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement, including Highly Automated QT, which has been validated by pharmaceutical companies and accepted by the FDA as equivalent to the manual evaluation of ECGs in Thorough QT studies. In addition, iCardiac provides Beyond QT, a suite of advanced ECG-based cardiac safety markers that have been accepted as secondary end-points by the regulators, and deliver a more accurate assessment of the cardiac safety profile of drugs in development. iCardiac’s COMPAS technology has been used for over a decade in cardiac clinical trials conducted for and by leading large and medium sized pharmaceutical, biotechnology, and medical device companies. For more information, visit: www.icardiac.com.
