FrontMatter -- Reviewers -- Preface -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Summary -- 1 Introduction -- 2 Review: Evaluating and Regulating Biomarker Use -- 3 The Biomarker Evaluation Process -- 4 Case Studies -- 5 Strengthening Evidence-Based Regulation -- Acronyms -- Glossary -- Appendix A: Table of Papers About Biomarker Qualification -- Appendix B: Recommendations from Related IOM Reports -- Appendix C: Committee Member and Consultant Biographies -- Appendix D: Staff Biographies -- Appendix E: Workshop Agenda -- Appendix F: Speaker Biographies.