The University of Rochester Medical Center (URMC) and a local company iCardiac Technologies, Inc. have announced a collaborative agreement to push to market their technology, touted to “to determine more effectively, and earlier on in clinical trials, whether an experimental drug is toxic to the heart.”
The technology is based on proprietary COMPAS software, that does ECG analysis, thought to detect early cardiotoxicity:
COMPAS – which stands for Comprehensive Analysis of Repolarization Signal – allows researchers to target and evaluate specific data produced by ECGs called the QT interval, in addition to other advanced measurements intended to identify specific risks associated with a new drug. The QT interval measures the process of ventricular repolarization – the period between the heart’s contraction and recovery phase. While the period lasts only a fraction of a second, it represents an important determinant of a drug’s safety.
“Drug-induced prolongation of the QT interval is a critical indicator of toxicity,” said Couderc. [University of Rochester biomedical engineer Jean-Philippe Couderc, Ph.D., an author of the software -ed.] “We know that individuals with an abnormally prolonged QT interval are at far greater risk for developing fatal arrhythmias and sudden cardiac death. Consequently, effective and precise measurement of QT interval, which COMPAS provides, is an effective tool in the assessment of cardiovascular toxicity. Further, the COMPAS software will enable iCardiac Technologies to also focus on the development and deployment of additional ECG markers, which are even more specific and sensitive than traditional QT interval measurements for determining cardiac toxicity.”
While there are several potential uses for this technology, the most immediate application is in clinical trials. Prolongation of the QT interval is the most common cause of drug withdrawal from the market and delays in regulatory approval. In the aftermath of the withdrawal of Vioxx and other Cox-2 inhibitor drugs over concerns that they may cause heart attacks or stroke, the FDA has proposed guidelines that call upon the pharmaceutical industry to develop better measurement methods for drug safety assessment.
In response, pharmaceutical companies are in the process of investing significant resources in research that will allow them to identify cardiac toxicity at early stages of drug testing. There is also a tremendous economic incentive; it is estimated that it costs, on average, $900 million to bring a new drug from the laboratory to the doctor’s office. This new scrutiny impacts large classes of drugs, such as antibiotics, weight loss, anti-psychotic medications, heartburn medications, and some cancer and heart disease therapies, some of which have been pulled from the market or limited in use due to their tendency to prolong the QT interval.
COMPAS was designed to accurately identify ECG abnormalities, while taking into consideration other factors that may influence a person’s heart activity, such as eating and stress. In fact, the FDA has purchased a license to the COMPAS software to evaluate its unique capabilities.