NewCardio, Inc., a cardiac diagnostic and services company, revealed the results of its third external validation study of QTinno(TM) (the "NCE3 Study"). Test validates QTinno(TM) – proves the ability to automatically measure QT intervals in even challenging samples 

QTinno(TM) is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators.

The study was led by an independent industry leading cardiac safety expert with extensive experience in pharmaceutical clinical trials. The study evaluated the accuracy, precision and speed of NewCardio's lead product, QTinno(TM), in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. Such data is now required by drug regulatory bodies worldwide for all new drugs in development, and at present must be obtained by expensive and time-consuming manual or semi-automated methods.

The NCE3 study was a randomized, blinded study of more than 2,500 digital ECGs acquired from healthy research subjects treated with either placebo or a cardiac drug with significant QT-prolonging properties and a known propensity to cause serious cardiac arrhythmias. QT intervals were determined on all study ECGs by QTinno(TM) and by the current "gold standard" approach: careful manual reading by a single cardiologist with extensive expertise and experience in ECG evaluation. The primary endpoint, time-matched, placebo-controlled QT prolongation induced by drug, was chosen because drug-induced QT prolongation is the primary parameter that regulatory bodies evaluate to assess the cardiac arrhythmia risk of a new drug candidate.