Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics - Workshop Summary Book

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