Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:


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 phase. Drugs that prolong the recovery phase are of concern, because they can be toxic to the heart. 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.

Many drugs have been pulled from the market – or the FDA has limited their use – due to the tendency to prolong the QT interval. Usually this occurs, however, after millions of patients have already suffered serious side effects. The list includes antibiotics, weight loss and anti-psychotic medications, heartburn medications, and some cancer and heart disease therapies. (See for a partial listing.) Therefore, the goal among those who are developing and testing new treatments is to identify the cardiovascular risks to patients at the earliest possible stage.

The Medical Center’s Heart Research Follow-up Program is a national and international leader in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT Syndrome (LQTS). The university keeps an international registry for LQTS, and follows thousands of families who have this inherited condition. The genetic form of the QT prolongation syndrome is similar to the drug-induced syndrome, and Couderc’s work focuses on developing the tools to identify individuals with either form.

Leslie Orr | EurekAlert!
Further information:

More articles from Health and Medicine:

nachricht NIH scientists describe potential antibody treatment for multidrug-resistant K. pneumoniae
14.03.2018 | NIH/National Institute of Allergy and Infectious Diseases

nachricht Researchers identify key step in viral replication
13.03.2018 | University of Pittsburgh Schools of the Health Sciences

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Tiny implants for cells are functional in vivo

For the first time, an interdisciplinary team from the University of Basel has succeeded in integrating artificial organelles into the cells of live zebrafish embryos. This innovative approach using artificial organelles as cellular implants offers new potential in treating a range of diseases, as the authors report in an article published in Nature Communications.

In the cells of higher organisms, organelles such as the nucleus or mitochondria perform a range of complex functions necessary for life. In the networks of...

Im Focus: Locomotion control with photopigments

Researchers from Göttingen University discover additional function of opsins

Animal photoreceptors capture light with photopigments. Researchers from the University of Göttingen have now discovered that these photopigments fulfill an...

Im Focus: Surveying the Arctic: Tracking down carbon particles

Researchers embark on aerial campaign over Northeast Greenland

On 15 March, the AWI research aeroplane Polar 5 will depart for Greenland. Concentrating on the furthest northeast region of the island, an international team...

Im Focus: Unique Insights into the Antarctic Ice Shelf System

Data collected on ocean-ice interactions in the little-researched regions of the far south

The world’s second-largest ice shelf was the destination for a Polarstern expedition that ended in Punta Arenas, Chile on 14th March 2018. Oceanographers from...

Im Focus: ILA 2018: Laser alternative to hexavalent chromium coating

At the 2018 ILA Berlin Air Show from April 25–29, the Fraunhofer Institute for Laser Technology ILT is showcasing extreme high-speed Laser Material Deposition (EHLA): A video documents how for metal components that are highly loaded, EHLA has already proved itself as an alternative to hard chrome plating, which is now allowed only under special conditions.

When the EU restricted the use of hexavalent chromium compounds to special applications requiring authorization, the move prompted a rethink in the surface...

All Focus news of the innovation-report >>>



Industry & Economy
Event News

Virtual reality conference comes to Reutlingen

19.03.2018 | Event News

Ultrafast Wireless and Chip Design at the DATE Conference in Dresden

16.03.2018 | Event News

International Tinnitus Conference of the Tinnitus Research Initiative in Regensburg

13.03.2018 | Event News

Latest News

A new kind of quantum bits in two dimensions

19.03.2018 | Physics and Astronomy

Scientists have a new way to gauge the growth of nanowires

19.03.2018 | Materials Sciences

Virtual reality conference comes to Reutlingen

19.03.2018 | Event News

Science & Research
Overview of more VideoLinks >>>