The industry is entering a period of accelerating conversion from outdated cardiac safety evaluation methods to more advanced, sophisticated techniques.
Rochester, New York (PRWEB) April 22, 2010
iCardiac Technologies, Inc., a provider of next generation cardiac core lab services, announced today that a top 10 pharmaceutical company has awarded iCardiac a cardiac safety study leveraging iCardiac’s COMPAS technology platform including advanced ECG biomarker analyses.
"The industry is entering a period of accelerating conversion from outdated cardiac safety evaluation methods to more advanced, sophisticated techniques," said Sasha Latypova, Executive Vice President. "Drug cardiac safety is rapidly evolving with tougher standards imposed by the regulators. We are proud to be able to leverage iCardiac’s team of experts and our advanced technologies to deliver the next generation of advanced ECG analytics and services for improving the precision, accuracy and resource efficiency of global cardiac safety studies."
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, high rate of false positives/negatives and high cost of the “gold standard” manual or semi-automated QT measurements has lead to efforts toward providing more advanced cardiac safety analytics.
About iCardiac Technologies
iCardiac Technologies, Inc., provides drug development companies worldwide with the complete range of next generation cardiac safety core lab services. Its team of cardiac safety experts collectively bring over 100 years of cardiology, electrophysiology, drug development, regulatory and academic experience. The iCardiac team pioneered the field of Highly Automated QT evaluation as well as controlling for autonomic nervous system effects on the QT interval, a phenomenon estimated to produce false-positive results in conventional QT studies for as many as 25% of all molecules currently in clinical development. iCardiac’s services are supported by the COMPAS technology platform which maximizes the precision and decreases the cost of cardiac safety assessment from First-in-Human studies to Phase III studies. This suite of tools, which complies with the FDA’s ICH E14 QT/QTc guidance for Through QT Studies (TQT), was originally developed and validated at the University of Rochester’s Heart Research Follow Up Program (HRFUP), as well as in Pfizer’s Research and Development programs. iCardiac’s analytics have been used for over a decade in support of clinical trials.
# # #