SANTA CLARA, Calif., - NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that a top-five pharmaceutical company has named NewCardio's QTinno(TM) software suite, NewCardio's first commercial product, as the technology that will be used in all of its fully automated Thorough QT (TQT) studies.
The pharmaceutical company evaluated several automated cardiac safety solutions before choosing QTinno(TM) as its automated solution moving forward. As part of this evaluation, a blinded TQT dataset was provided for processing by the automated solutions. The automated results were then un-blinded by the pharmaceutical company and compared to the original core lab results. The pharmaceutical company determined that NewCardio's solution demonstrated the highest consistency and lowest variability in relation to the original core lab results. After reviewing NewCardio's underlying platform technology, the pharmaceutical company determined that QTinno(TM) was the solution it will utilize to begin replacing the semi-automated methodology currently utilized by its preferred ECG core labs. At recent industry conferences, a number of pharmaceutical companies have expressed a strong desire to transition to fully automated methods in an effort to reduce human error, minimize intrinsic variability and increase efficiency.
Going forward, all TQT study requests for proposals (RFPs) issued by the pharmaceutical company that will require a fully automated component will require the use of NewCardio's QTinno(TM) by its preferred ECG core labs. It is anticipated that this pharmaceutical company will conduct its first clinical trial using fully automated readings by the end of the year and will increasingly utilize fully automated results in its TQT studies.
"NewCardio is excited to work with a major pharmaceutical company and we believe this is the clearest signal yet of the impending transition to fully automated cardiac testing in drug development as sponsors look for ways to improve quality while simultaneously reducing expenses," said Vincent Renz, NewCardio's President and Chief Operating Officer. "This global pharmaceutical leader is an early adopter, and this announcement demonstrates their commitment to quality, safety and the use of new technologies to drive innovation."
NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno(TM), a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno(TM), software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development.
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