FDA purchases Med Center software
he Food and Drug Administration (FDA) recently purchased a copy of a software program developed by Jean-Philippe Couderc, research assistant professor of cardiology, that helps assess whether a medication might be harmful to the heart. Called COMPAS (Comprehensive Analysis of Repolarization Signal), the program provides a more accurate way to analyze the electrocardiograms (EKGs) of people who volunteer for clinical trials to test new drugs.
"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," says Couderc, 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.
COMPAS was designed to accurately identify EKG abnormalities, while taking into consideration other factors that may influence a person's heart activity, such as eating, exercise or stress. COMPAS also assesses cardiac drug toxicity by automating the reading process.
John Fahner-Vihtelic, deputy director for the Medical Center's office of technology transfer, says the University hopes to license the copyrighted software to drug companies and other institutions involved in premarket drug testing.
Maintained by University Public Relations
Please send your comments and suggestions to:
Public Relations.
