Metric Applied in Alternative iCardiac Safety Assessment Method

The metric is intended to accelerate the use of Phase I QT data as an alternative to the TQT study

      April 20, 2016, Rochester, N.Y.-iCardiac Technologies, Inc., a market and innovation leader in cardiac safety and respiratory studies, announced today that it has implemented a new, advanced quality metric into its Phase I QT assessment services.     The metric, which iCardiac calls Method Bias Sensitivity (MBS), quantifies whether an ECG core lab’s methodology for measuring QT intervals is introducing any bias into the study results, therefore enabling sponsors and regulators to better assess if the study results are reliable. The company is offering MBS assessment in all new Phase I or other studies where QT is being measured for the purpose of seeking a waiver of a Thorough QT (TQT) study.   Findings related to the MBS metric were presented on April 6th at a workshop hosted by the Cardiac Safety Research Consortium in Washington D.C.    iCardiac helped to develop and test the new metric in collaboration with a number of regulatory and industry thought leaders. The effort was undertaken in response to a known limitation that, unlike with TQT studies that contain a positive control arm, Phase I QT assessment does not incorporate ways to measure the study’s ability to exclude a small QT effect. Bias introduced by the core lab's ECG measurement methodology could lead to a false negative result, in that the study incorrectly concludes that there is no QT prolongation. MBS helps to address this concern by evaluating the extent of any methodology bias, thereby protecting against the possibility of a false negative result.     The development of a new quality metric is another important step forward in accelerating the adoption of an alternative to TQT trials. iCardiac has been pioneering this effort and was the sole core lab to sponsor and participate in the IQ-CSRC prospective study in 2014 that validated the alternative approach using exposure response analysis. A year after the results were shared, the ICH E14 regulatory guidance was revised to support this alternative method.    “This metric was developed to minimize the possibility of a false negative result, which is especially helpful in studies where supratherapeutic plasma concentrations are not reached,” said Dr. Borje Darpo, a cardiologist and iCardiac’s Chief Scientific Officer. “It will serve as an objective indicator to confirm that data being submitted by a sponsor seeking a TQT waiver is unbiased.”   “iCardiac has been a clear leader in developing, validating and popularizing the use of early QT data as an alternative to doing a TQT study,” said Alex Zapesochny, President & CEO of iCardiac. “We are pleased to have once again helped to introduce an important new innovation in the field, and to be the first in the industry to implement that innovation into a standard service offering.”   

About iCardiac Technologies:

iCardiac Technologies, Inc. is an industry-leading centralized core laboratory for cardiac safety and respiratory services. Its high precision cardiac safety assessment methodology has set a new standard for precision and accuracy in all phases of clinical trials. The company serves 8 of the top 10 global pharmaceutical companies, as well as numerous small and mid-sized pharma and biotechnology firms. For more information, please visit:

www.icardiac.com

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