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Advancing Biomarkers and Diagnostics: Effective Standards for Clinical Relevance

This document discusses the adoption of pragmatic and cost-effective standards for the accurate and reproducible longitudinal quantitation of biologic parameters with clinical relevance. It emphasizes the intersection of biomarkers and diagnostics, focusing on how these elements can improve drug development by providing access to essential biomarkers. Key topics include automation, workflow, categorical thresholds, and the importance of individualized medicine in monitoring drug effects and benefits. The document outlines milestones from previous RSNA conferences to highlight advancements in imaging and interoperability.

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Advancing Biomarkers and Diagnostics: Effective Standards for Clinical Relevance

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Presentation Transcript

  1. Version 10

  2. Mission; Foster adoption of… • pragmatic and cost effective standards for • accurate and reproducible • longitudinal • quantitation of • biologic parameters • with clinical relevance • and known sigma

  3. H/o Commercial Dx Individuals - thresholds Categorical, staging Workflow/# studies Binary – choice of Rx Biomarkers become Dx Populations – means Continuous, quantitative Automation/bias Longitudinal – Rx effect Monitoring Rx Benefit = Individualized MedicineConvergence of Biomarkers and Diagnostics Quantifying the effects of drugs in development may beg access to biomarkers as diagnostics

  4. RSNA ’10 and on Milestone horizon/PET-CT RSNA ‘09 Calibration Phantoms Characterization Lo, Hi rads RoI Definition* Dynamic Range lesion size** RSNA ‘08 Interoperability of Results Encoding Image Quality Metrics Quantitation Computation Documentation of terms High High High High Medium High Value H, M, L High High High High High Feasibility H, M, L High *Adoption 2010-11, but Define by 2008 Priority H, M, L N/A Quick Hits **Ideal Phantom 2010-11 Current phantom by 2008 Chair H, M, L TBN Clunie

  5. Version 10

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