NewCardio Presents Results for Cardiac Safety Research Consortium Blinded Drug Safety Study
QTinno reduces measurement variability and improves data quality in independent validation study
SANTA CLARA, CA (December 10, 2010) -
PR Newswire - NewCardio, Inc., (OTC BB: NWCI) a cardiovascular diagnostic solutions developer, today presented the results from a blinded drug safety study conducted by the Cardiac Safety Research Consortium (CSRC) to evaluate the performance of QTinno™ on its "testing" ECG dataset. The CSRC blinded "testing" dataset, comprised of 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent parallel-group Thorough QT Study. The CSRC blinded study results show, by a variety of analytical approaches, that QTinno accurately detects moxifloxacin-induced QT interval prolongation with statistically significant and substantial reductions in measurement variability compared to sponsor-submitted data. In QT studies, lower measurement variability increases the quality of study results and may enable future studies to be done in a more cost effective manner, thereby potentially reducing expenses for cardiac safety studies, which is a significant value proposition for QTinno users.
The study results were presented yesterday (December 9, 2010) to key representatives from the Food and Drug Administration (FDA), pharmaceutical companies, and academia by Samuel George, MD, FACC, JD, NewCardio's Senior Medical Advisor, at the CSRC's Annual Meeting. The CSRC makes its blinded "testing" dataset available to any cardiac safety technology developer who accepts the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any results obtained will be made public by the CSRC (www.cardiac-safety.org/ecg-database/rules_of_engagement.pdf). NewCardio is the first such entity to accept the CSRC conditions and complete the study.
Vincent Renz Jr., NewCardio's President and CEO commented, "We are very excited that QTinno was the initial automated cardiac safety solution whose performance was evaluated against the CSRC blinded 'testing' data set, for two reasons. First, based on the QTinno validation studies done to date with partners from Pharma, clinical trial service providers and academia, we expected, and realized, statistically significant results from this blinded drug safety study. QTinno has consistently returned highly accurate results with lower variability than other comparator methods, be it manual, semi-automated or automated, just as it did in the CSRC study. And second, it provided another opportunity for us to enhance our collaborative efforts with the CSRC in utilizing the underlying science and technology of QTinno to advance the current state of cardiac safety testing."
In the study, the CSRC made detailed comparisons of QTinno measurements to those originally submitted to the FDA by a drug sponsor in an FDA mandated cardiac safety drug study as required under the ICH E14 Guidance. The primary endpoint of this analysis was the accurate detection of the control drug's (moxifloxacin) effect on QT intervals, and the precision of the submitted measurements. Detailed results of this study will be submitted for publication in a peer-reviewed journal in the near future, and will be posted on the NewCardio website after peer-reviewed publication.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, stated, "We commend the CSRC for the excellent design and execution of this very important study, and we are proud that QTinno once again proved its accuracy in this rigorous examination. The study results provide compelling, and completely independent evidence that QTinno returns industry leading, fully automated accuracy in clinical drug studies, and does so with significantly reduced measurement variability. We believe that QTinno has the potential to increase the power of future studies and reduce study expenses for pharmaceutical drug sponsors."
Mr. Renz, continued, "Validation of new technologies is critical, and FDA representatives have consistently stated that they are willing to accept clinical results using automated ECG measurements from any validated methodology and the results from all of our validation efforts, which now include this CSRC study, more than meet FDA standards for validation, and as such QTinno is acceptable to the FDA. We believe that there will come a point where, based on the quality of performance, the industry will move from validation to the acceptance of methodologies which not only deliver high quality results, but do so in a more timely and cost effective manner. The blinded CSRC study results reinforce the strength of QTinno's performance with both current and potential customers and, more importantly we believe this clearly establishes the critical role of QTinno as the drug development industry accelerates their adoption of the higher quality, cost effective cardiac safety analysis."
About QTinno Technology
NewCardio's patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno's faster, more accurate and less expensive assessment of cardiac status.
