Figure 1.

Institute of Medicine Roadmap for omics-based tumor biomarker test development.The first stage encompasses discovery of a biologically, and perhaps clinically, interesting omics-based tumor biomarker and development of an analytically-validated tumor biomarker test with clinical validity. The second stage is directed towards evaluation for clinical utility and use of the tumor biomarker test, either in a prospective-retrospective study using archived specimens or in prospective clinical trials designed to 'test the test' for its intended clinical use. Reprinted with permission from reference [6] by the National Academy of Sciences, Courtesy of the National Academies Press, Washington, D.C.

Hayes BMC Medicine 2013 11:221   doi:10.1186/1741-7015-11-221
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