iCardiac Processes Volume of Data Equivalent to One Thousand Traditional Thorough QT Studies

Share Article

Establishes New Throughput Standard in Cardiac Core Lab Industry

We are enthusiastic about our continued string of industry firsts

iCardiac Technologies, Inc., a leader in advanced cardiac safety biomarker development and automated QT analysis, announced that it has processed a total of 45 million cardiac cycles for agency facing studies in a single month utilizing the company's Highly Automated QT(sm) method. The total volume of data represents the same number of cardiac cycles as would traditionally be evaluated in approximately one thousand TQT studies.

"We are enthusiastic about our continued string of industry firsts," said Sasha Latypova, Executive Vice President. "Our clients are gaining significant benefits from our advanced ECG methods, rapid turnaround times and highly scalable core lab processing capacity to meet their drug development needs."

In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision and high cost of the "gold standard" manual QT measurements has lead to efforts toward automating QT interval measurement.

About iCardiac Technologies
iCardiac Technologies, Inc. is a technologically differentiated cardiac core lab providing expert scientific consultation, end-to-end project management, statistical analysis and the industry's most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac's analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement, including Highly Automated QT, which has been validated by pharmaceutical companies and accepted by the FDA as equivalent to the manual evaluation of ECGs in Thorough QT studies. In addition, iCardiac provides Beyond QT, a suite of advanced ECG-based cardiac safety markers that have been accepted as secondary end-points by the regulators, and deliver a more accurate assessment of the cardiac safety profile of drugs in development. iCardiac's COMPAS technology has been used for over a decade in cardiac clinical trials conducted for and by leading large and medium sized pharmaceutical, biotechnology, and medical device companies. For more information, visit: http://www.icardiac.com.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Sasha Latypova
Visit website