NewCardio Inc. is a cardiac diagnostic and services company developing and marketing proprietary software technologies for the monitoring and diagnosis of cardiovascular disease, as well as cardiac safety assessment of drugs under development.
The company today announced 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. QTinno is New Cardio’s patented software technology used to assess drug cardiac toxicity in drug development.
The CSRC study results demonstrate QTinno’s ability to accurately detect the control drug’s (moxifloxacin)-induced QT interval prolongation, as well as its ability to effectively and significantly reduce measurement variability, which increases the quality of, while lowering the cost of, study results.
Dr. Ihor Gussak, NewCardio’s chief medical officer, said the 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.”
Vincent Renz Jr., NewCardio’s president and CEO, also outlined the importance of the results.
“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,” Renz stated in the press release. “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.”
The study compared QTinno measurements to those originally submitted to the FDA by a drug sponsor. CSRC’s study results were presented yesterday to “key representatives” of the FDA, pharmaceutical companies, and academia at the CSRC’s Annual Meeting.
“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,” Renz concluded.
For more information visit www.newcardio.com