OBS Medical Completes BioQT Cardiac Safety Analysis Supporting Prospective Drug Study
Posted on: Tuesday, 7 October 2008, 12:00 CDT
OBS Medical announced today the successful completion of a cardiac safety analysis in support of a pharmaceutical sponsor's prospective drug study.
BioQT(TM) is an advanced signal processing technique developed by OBS Medical. It provides efficient and accurate measurement of ECG QT interval, T wave morphology and other cardiac safety parameters assessed in drug trials. BioQT(TM) is a thorough and efficient way to produce accurate cardiac safety profiles for new and existing drugs.
The recently completed BioQT-enabled cardiac safety analysis was conducted on Holter ECG data to assess the investigational drug's effects on cardiac repolarization in normal volunteers who were randomized to drug or placebo. OBS Medical analyzed over 5 million individual heart beats, using both fully automated and semi-automated processing (the latter includes cardiologist oversight). BioQT's comprehensive outputs include QT interval assessment, T wave morphology assessment, benchmarking analysis (drug vs. placebo, drug vs. positive control), and a cardiologist's interpretation.
OBS Medical believes that this study may be the industry's first in which a high-throughput analytical platform was used prospectively to analyze QT and T wave morphology changes of a drug compound under active FDA review. BioQT data was among the information FDA used to allow the drug to move into its next phase of development.
"We believe that BioQT results from definitive QT studies can be submitted to FDA in lieu of conventional ECG data, so long as an active control is included," commented Dr. Jay Mason, a renowned and respected cardiac safety expert and Chief Medical Officer for OBS Medical. "BioQT has the capability to analyze a much greater quantity of electrocardiographic data in each subject as compared to conventional methods of analysis. The result is much greater specificity and sensitivity for abnormal repolarization, and this allows drugs to be evaluated more accurately, with fewer subjects exposed, in smaller, less expensive trials. In addition, T wave morphological analysis adds insight into the clinical significance of drug-related QT prolongation."
About OBS Medical
OBS Medical is based in Carmel, Indiana and provides innovative clinical algorithms for safer hospitals, safer patients and safer drugs. Based on intelligent algorithms such as neural networks, data fusion and ECG waveform recognition, OBS Medical technologies cover a range of medical applications including automated early crisis warning (Visensia(TM)), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT(TM)), and EEG analysis for brain-state assessment. OBS Medical is a wholly-owned subsidiary of Oxford BioSignals Ltd. based in Oxford, UK, which was originally spun out from Oxford University.
Source: Business Wire
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