NewCardio to Present Results of QTinno Performance on Cardiac Safety Research Consortium Blinded 'Testing' Dataset
SANTA CLARA, Calif., Nov. 9, 2010 /PRNewswire-FirstCall/ -- NewCardio, Inc. (OTC Bulletin Board: NWCI), a cardiovascular diagnostic solutions developer, announced today that Dr. Samuel George, NewCardio's Senior Medical Advisor, will present the results of QTinno performance on a blinded "testing" dataset, conducted independently by the Cardiac Safety Research Consortium (CSRC), at the CSRC's Annual Meeting, to be held on December 9, 2010, at the headquarters of the Food and Drug Administration (FDA) in Silver Spring, MD.
At the meeting, Dr. George will present results of a blinded validation study in which CSRC-affiliated investigators independently evaluated the accuracy and precision of fully automated QTinno measurements in 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent Thorough QT Study (TQTS). In the study, the CSRC investigators made detailed comparisons of QTinno measurements to those originally submitted by the drug sponsor, with the primary comparators of accurate detection of the moxifloxacin effect on QT intervals.
The CSRC makes this blinded TQTS "testing" dataset available to automated cardiac safety technology solution providers, with the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any (either favorable or unfavorable) results obtained will be made public. NewCardio is the first company which has agreed to these conditions and completed the evaluation.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, commented, "We are very proud to be the first automated cardiac safety solution to accept the rules of engagement defined by the CSRC for evaluating the performance of our automated solution, QTinno, utilizing the blinded CSRC 'testing' dataset. Our willingness to enter into this very important and strictly regulated validatio