Validation Study Affirms Highly Automated Cardiac Safety ECG Analysis for Global Leader in Drug Development
Rochester, New York (PRWEB) February 5, 2009 -- iCardiac Technologies, Inc., a leading innovator in advanced cardiac safety biomakers and automated QT analysis, today announced the successful completion of a study for one of the world's leading pharmaceutical companies. The study validated the use of its Highly Automated QT(sm) technology to measure a full spectrum of ECG-based cardiac safety study data from mild to pronounced QT prolongation.
The study, performed with data from an existing compound, compared results from iCardiac's Highly Automated QT analysis with measurements performed independently by a large ECG core laboratory. The analysis was performed on data that included patients who ingested a placebo, moxifloxin (used as a positive control in cardiac safety studies), a normal and a supra-therapeutic dose of a study drug.
"This represents one of several validation studies of our technology with industry-leading drug developers," said iCardiac's Co-Founder and Executive Vice President Sasha Latypova. "To date our Highly Automated QT technology has been applied in over 10 clinical QT data analyses. Pharmaceutical companies are gaining more accurate results and are lowering substantially the cost per TQT study."
The study is part of iCardiac's broader validation program that aims at both reducing the cost of cardiac safety studies and developing the next generation of ECG biomarkers that are more predictive than the QT interval for characterizing arrhythmia risk associated with novel medicines.
The drive to automate more of the cardiac safety analysis process stems from general dissatisfaction in the industry regarding "gold standard" manual measurements that are both time-consuming and expensive. iCardiac's Highly Automated QT technology is different from "fully automated" approaches - which are based solely on computers - because it combines advanced ECG signal processing algorithms, developed over the past decade, with a robust quality assurance process conducted by cardiologists.
The technology performs a precise automated QT measurement and, using sophisticated statistical models and algorithms, guides cardiologists to those ECGs that require attention. It produces significant cost savings because only a portion of the entire Thorough QT (TQT) dataset requires manual over-reading.
Highly Automated QT analysis is part of iCardiac's software platform COMPAS 3.0, originally developed at the University of Rochester Heart Research Follow-Up Program, the international leader in electrophysiology research and the study of the congenital Long QT Syndrome. The platform provides comprehensive analysis of cardiac repolarization signals and contains several advanced arrhythmia biomarkers, as well as advanced ECG signal processing tools. The 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 QT(sm), 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: www.icardiac.com.
Read the full story at http://www.prweb.com/releases/2009/02/prweb1957024.htm.
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