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FDA buys technology that identifies drug toxicity to heart

The University of Rochester Medical Center has a new tool to assess whether a medication might be harmful to the heart. The technology addresses a major health issue drug toxicity illustrated most recently by Merck's voluntary withdrawal of Vioxx from the market after concerns that it may cause heart attacks and strokes.

Jean-Philippe Couderc, a biomedical engineer, developed a software program that provides a simpler, more accurate way to analyze the electrocardiograms (EKGs) of people who volunteer for clinical trials to test new drugs. The Food and Drug Administration purchased a copy of the technology, called COMPAS, which stands for Comprehensive Analysis of Repolarization Signal. The university hopes to license the copyrighted software to drug companies and other institutions involved in pre-market drug testing, said John Fahner-Vihtelic, deputy director of the Office of Technology Transfer.

"Our program provides a more reliable method to identify cardiovascular toxicity at a time when the scientific community is diligently seeking ways to address this problem," said Couderc, Ph.D., M.B.A., a research assistant professor in the Cardiology department and assistant director of the Heart Research Follow-up Program. "We are confident that COMPAS will be a valuable tool in the clinical trial and drug development arena."

More comprehensive testing of the heart's reaction to medications is not only important for the success of any new drug, but it became an FDA requirement two years ago. To meet this standard, most companies that design Phase I and II clinical trials require thousands of volunteer subjects to undergo an extensive physical examination, which includes a review of a patient's 24-hour EKG.

The patient's EKG data is loaded onto a computer. Doctors look for abnormalities related to the QT interval. This is the split-second period that occurs from the time a heart beats or contracts, through its recovery phas
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Contact: Leslie Orr
leslie_orr@urmc.rochester.edu
585-275-5774
University of Rochester Medical Center
4-Nov-2004


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