Frost & Sullivan has awarded the COMPAS software technology platform its 2006 North America Technology Innovation of the Year Award in the field of Cardiac Safety Analytics.
The software was created at the University of Rochester Medical Center and is being commercially developed by iCardiac Technologies, a Rochester, New York-based company.
COMPAS, which stands for Comprehensive Analysis of Repolarization Signal, enables pharmaceutical companies to better analyze data from electrocardiograms (ECGs), to determine whether or not an experimental drug is toxic to the heart. This analysis includes traditional measurements of cardiac risk as well as advanced biomarkers currently being developed by the University of Rochester and iCardiac.
In describing why it chose iCardiac as the recipient of its prestigious innovation award, Frost & Sullivan noted that the U.S. Food & Drug Administration has published guidance that cardiac safety testing of new drugs should include a “thorough QT” test, which is an ECG-based measurement of the brief period between the heart’s contraction and recovery phases. Utilizing sophisticated algorithms, the COMPAS software is able to perform thorough QT tests with higher accuracy than other current methods. This improved precision results in up to a 30% cost savings.
Despite the FDA’s requirement, it is well known that this test is an imperfect predictor of a drug’s cardiac risk profile. For instance, there are cardiotoxic drugs that do not prolong the QT interval, as well as drugs that prolong the QT interval but are safe. The COMPAS software serves as a platform technology to develop other unique metrics from ECGs which would address the issue of false-positive and false-negative results in QT interval testing, which could lead to safe compounds being unnecessarily terminated and unsafe medicines reaching the market.
The University of Rochester and iCardiac are engaged in the development of the next generation of ECG biomarkers for assessing the level of cardiotoxicity of new compounds. These biomarkers do not rely on the QT interval exclusively but provide insight into abnormalities of specific portions of the repolarization interval from the surface ECGs. This additional information provides significant improvement in sensitivity and specificity for identifying drug-induced abnormalities of the repolarization process of the heart.
According to Frost & Sullivan, its recognition of iCardiac was based on the ability of COMPAS technology to help researchers make more informed decisions about whether or not to move forward with Phase II studies or instead focus on reengineering the drug compound, and that providing such an ability will likely reduce the number of situations where drugs that are brought to the market induce cardiac events.
“We are very proud of this recognition from Frost & Sullivan and are encouraged that this award further confirms the need for a technology platform such as COMPAS that enables the pharmaceutical industry to have a better set of tools in determining whether drugs that are being developed are safe for the heart,” said Jean-Philippe Couderc, Ph.D., who, as the assistant director of the University of Rochester Heart Research Follow-up Program and iCardiac’s chief technology officer, is the principal inventor of the COMPAS technology.
iCardiac received an exclusive global license from the University of Rochester in 2006 to commercialize the COMPAS technology. The company is continuing to enhance the technology and now offers it as part of its cardiac safety testing services.