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Introduction 1
Overview of Technologies Used to Discover Cancer Biomarkers 3
Genomics, Proteomics, and Metabolomics 3
Molecular Imaging 9
Meeting the Technical Challenges of Biomarker Validation and Qualification 11
Coordinating the Development of Biomarkers and Targeted Therapies 20
Therapeutics Industry Perspective 21
Diagnostics Industry Perspective 24
NCI Perspective 26
Clinical Investigator Perspective 28
Biomarker Development and Regulatory Oversight 29
FDA Critical Path Initiative 30
Oversight of Diagnostic Tests 32
Designing Clinical Studies of Biomarkers 36
Assessment and Adoption of Biomarker-Based Technologies 39
Federal Programs for Technology Assessment 40
Insurance Coverage Decisions and Practice Guidelines 43
CMS Coverage of Biomarkers 46
Economic Impact of Biomarkers 48
Cost-Effectiveness Analysis 48
The Value of Information and Research 53
Technology Assessment in the Private Sector 53
Clinical Development Strategies for Biomarker Utilization Discussion 57
Strategies for Implementing Standardized Biorepositories Discussion 61
Strategies for Determining Analytic Validity and Clinical Utility of Biomarkers Discussion 66
Strategies to Develop Biomarkers for Early Detection Discussion 69
Mechanisms for Developing an Evidence Base Discussion 73
Evaluation of Evidence in Decision Making Discussion 76
Incorporating Biomarker Evidence into Clinical Practice Discussion 80
Acronyms 85
Glossary 86
References 92
Appendixes
Workshop Agenda 93
Workshop Speakers, Moderators, Invited Discussants, and Participants 99
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