BioQT Brochure


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BioQT Brochure - 1

10401 N. Meridian St. Ste. 300 St. Indianapolis, IN 46290 (317) 581-9236 Fax (317) 581-8941 Toll-Free (866) 424-6744 174 Milton Park Abingdon Oxon OX14 4SE United Kingdom +44-1235-432050 Efficient Safety Analysis Clinically Validated Holter recordings made in a TQT study provide a large amount of data, only a small fraction of which can be analysed manually. Two key features are required for a tool that will take full advantage of all the data: BioQT was used in the industry’s first algorithmbased prospective study. Thousands of hours of Holters and millions of ECGs have validated BioQT’s accuracy and efficacy. • Fast automated analysis, typically a few minutes to analyse 24 hours of continuous data. • Robust detection and elimination of unmeasurable beats. In comparison to the traditional method, more robust results are generated with statistical significance. The algorithm separates high-quality signals from noise by assigning confidence levels for each beat. BioQT provides both of these features using advanced signal processing technology similar to that used in automatic speech recognition. As well as QT interval measurement, it also provides: OBS 1007 Manual Vs Automated QTcF R2 = 0.93 High correlation with manual readings (R2 = 0.82-0.93) • Beat-by-beat confidence measures • T wave morphology assessment • Manual overread capability “BioQT has the capacity to analyse a much greater quantity of electrocardiographic data in each subject as compared to conventional methods of analysis. The result will be a greater specificity and sensitivity for abnormal repolarization which will allow drugs to be more accurately evaluated with fewer subjects exposed in smaller less expensive trials” BioQT Benefits Jay Mason, M.D. Consulting Chief Medical Officer • Validated against manual measurements, and shown to be more consistent. • Unique confidence measure on every beat – rejects artefactual and corrupted beats. • Fewer subjects required, reducing unneeded human exposure and study costs • Can exonerate compounds that have QT effect but do not alter T wave morphology • Clinical advantages - Avoidance of misleading ECG outliers - More accurate identification of treatment status - Much smaller standard deviation of QTc - T wave morphology assessment and insights OBS 1008 Manual Readings – Placebo Only Additional features in next release • General interval analysis in addition to QT: - PR - QRS • RMS analysis – uses all independent ECG leads instead of one lead. - Allows more beats to be analysed with high confidence. - Reduces scatter by averaging across leads. 001-1712-MM –R4 OBS 1008 – BioQT Automated – Placebo Only Issued 9 June 2011 Significantly reduced Standard Deviation (↓ 31%)

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