iCardiac automated ECG QT method validation study ends
iCardiac Technologies, a cardiac safety biomarkers company, has completed its validation study for an automated ECG analysis technology, making it the first to comply with the FDA E14 industry guidance.
In the study, conducted with pharmaceutical companies and academic partners, the Rochester, N.Y.-based iCardiac said its automated QT method has demonstrated results equivalent to manual measurements performed independently by U.S. board-certified cardiologists. The company said its automated QT method was shown to detect the effect of the drug moxifloxacin, which is used as a positive control in cardiac safety studies and is included in the FDA’s E14 industry guidance.
The study is part of iCardiac’s broader validation program that aims at developing the next generation of ECG biomarkers that are more predictive than the QT interval for characterizing arrhythmia risk associated with novel medicines, the company said.
In the study, conducted with pharmaceutical companies and academic partners, the Rochester, N.Y.-based iCardiac said its automated QT method has demonstrated results equivalent to manual measurements performed independently by U.S. board-certified cardiologists. The company said its automated QT method was shown to detect the effect of the drug moxifloxacin, which is used as a positive control in cardiac safety studies and is included in the FDA’s E14 industry guidance.
The study is part of iCardiac’s broader validation program that aims at developing the next generation of ECG biomarkers that are more predictive than the QT interval for characterizing arrhythmia risk associated with novel medicines, the company said.