biomarker discovery and development that the committee agreed warranted further attention, including biorepositories, consortia, and demonstration projects.

Chapter 3 reviews current oversight of biomarker development and use by federal agencies (Food and Drug Administration and Centers for Medicare and Medicaid Services). It examines a variety of approaches to improve the development and evaluation process and to ensure the quality of biomarker tests used by patients and physicians while also fostering innovation.

Chapter 4 provides a brief overview of the technology evaluation and adoption processes and examines possible ways to facilitate data collection and analysis to monitor and improve the value of biomarker tests.


Ariazi EA, Ariazi JL, Cordera F, Jordan VC. 2006. Estrogen receptors as therapeutic targets in breast cancer. Current Topics in Medicinal Chemistry 6(3):181-202.

Austin M, Babbiss L. 2006. Commentary: When and how biomarkers could be used in 2016. AAPS Journal 8(1):E185-E189.

Baselga J. 2006. Targeting tyrosine kinases in cancer: The second wave. Science 312(5777): 1175-1178.

Biomarkers Definitions Working Group. 2001. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69:89-95.

Bullinger L. 2005. Gene expression profiling in acute myeloid leukemia. Haematologica 91(6):733-738.

Bullinger L, Doner H, Pollack JR. 2005. Genomics in myeloid leukemias: An array of possibilities. Reviews in Clinical and Experimental Hematology 9(1):E2.

Caprioli RM. 2005. Deciphering protein molecular signatures in cancer tissues to aid in diagnosis, prognosis, and therapy. Cancer Research 65(23):10642-10645.

Chandra S, Muir C, Silva M, Carr S. 2005. Imaging biomarkers in drug development: an overview of opportunities and open issues. Journal of Proteome Research 4(4):1134-1137.

Dalton WS, Friend SH. 2006. Cancer biomarkers—an invitation to the table. Science 312(5777): 1165-1168.

Druker BJ. 2004. Imatinib as a paradigm of targeted therapies. Advances in Cancer Research 91:1-30.

Duffy MJ. 2005. Predictive markers in breast and other cancers: A review. Clinical Chemistry 51(3):494-503.

FDA (Food and Drug Administration). 2004. Challenge and Opportunity on the Critical Path to New Medical Products. [Online]. Available: [accessed September 2006].

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement