Strategies for Genomic and Proteomic Profiling of Cancers |
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Authors: | Gilbert S Omenn |
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Institution: | 1.University of Michigan,Ann Arbor,USA |
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Abstract: | Omics-based technology platforms have made new kinds of cancer profiling tests feasible. There are several valuable examples in clinical practice, and many more under development. A concerted, transparent process of discovery with lock-down of candidate assays and classifiers and clear specification of intended clinical use is essential. The Institute of Medicine has now proposed a three-stage scheme of confirming and validating analytical findings, validating performance on clinical specimens, and demonstrating explicit clinical utility for an approvable test (Micheel et al., Evolution of translational omics: lessons learned and path forward, 2012). |
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