This is an important step for cardiac safety testing
Rochester, New York (PRWEB) April 1, 2009
iCardiac Technologies announced today that its advanced cardiac safety biomarkers were used successfully in a clinical study to model the effect of a serious disease on the heart's repolarization process.
The repolarization biomarkers, captured on a continuous electrocardiogram, played a key role in helping a leading pharmaceutical company to model the effects of disease on cardiac repolarization. The information provided by iCardiac's advanced morphological biomarkers enables drug developers to separate reliably the cardiac effects triggered by experimental drugs.
"This is an important step for cardiac safety testing," said iCardiac's Co-Founder and Executive Vice President Sasha Latypova. "Up until now there has not been a means for pharmaceutical companies to separate conclusively QT prolongation that originates with the disease state from that which stems from the drug being tested."
iCardiac's advanced ECG-based biomarkers enable a comprehensive evaluation of cardiac repolarization morphology and dynamics. The repolarization process - represented by what is called the QT interval, as measured on an ECG - is the brief period of time between two heart beats and is known to be a vulnerable time for arrhythmia induction. In rare instances, drug-induced arrhythmias can lead to sudden cardiac death.
iCardiac's COMPAS software platform performs digital quantification of repolarization abnormalities and enables measurement of subtle differences in ECG signals that may indicate arrhythmia predisposition. iCardiac's validation studies conducted at the University of Rochester have demonstrated that quantification of such morphological changes complement and improve upon information gathered from QT interval studies.
The study also included iCardiac's validated Highly Automated QT analysis. The highly automated solution combines advanced ECG signal processing algorithms developed over the past decade with a robust quality assurance process conducted by cardiologists. It has been validated in over 10 clinical QT studies and has been accepted by the FDA as equivalent to the manual evaluation of ECGs in Through QT studies.
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: http://www.icardiac.com.