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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Omenn, G.S. Strategies for Genomic and Proteomic Profiling of Cancers. Stat Biosci 8, 1–7 (2016). https://doi.org/10.1007/s12561-014-9111-7
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DOI: https://doi.org/10.1007/s12561-014-9111-7