Fully automated QT measurements, obtained from VivaQuant Rhythm Express software, with no human review or editing, were shown to improve accuracy of concentration effect models used in drug safety assessment by 22 percent
St. Paul, MN - VivaQuantTM is pleased to announce publication of the results of a study comparing two software programs for deriving markers of cardiac safety used in drug development. The article can be found in the most recent issue of Clinical Pharmacology and Therapeutics. In the study, the Rhythm ExpressTM software was used to automatically measure QT intervals from a publicly available database provided by FDA. QT measurements were not reviewed or edited. Markers of cardiac risk were then computed using the Rhythm Express QT values and compared with markers computed from QT values from the FDA database.
The comparison demonstrated that the VivaQuant QT measurements were equivalent to those provided by FDA, but the confidence limits on the cardiac risk markers were 22 percent tighter. Tighter confidence limits results in improved accuracy and can lead to a clearer decision on whether a drug is safe and ultimately reduce the cost of drug development. "This paper represents the first independent validation of FDA efforts and greatly adds to the impact of this important refinement in the definition of adverse cardiac effects of new medications," says Dr. Daniel Goodman, Medical Director at Biotelemetry Research. "Our company performs highly exacting ECG analysis to support regulatory submissions by the pharmaceutical industry. We have made extensive use of VivaQuant's innovative technology for QT and subinterval measurement and concentration effect modeling and will continue to do so."
This work was supported in part by a grant from the National Institute on Drug Abuse of the National Institutes of Health under Award Number R44DA041815 and by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R43HL110739.
*QT interval is the time required for the main chambers of the heart to electrically depolarize (contract) and repolarize (relax). QT is used to gauge the cardiac safety of new drugs and a QT assessment is almost always required by FDA for a drug to be approved for sale.
VivaQuant provides ECG analysis services to evaluate the safety and efficacy of drugs and devices. Its patented Multi-Domain Signal Processing (MDSPTM) technology removes up to 95 percent of noise and artifact in ambulatory ECGs, resulting in improved measurement accuracy and less labor.