Strategies for Genomic and Proteomic Profiling of Cancers.
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).
University of Michigan, Ann Arbor, MI 48109-2218, USA.
Gilbert S
GS
Omenn
Bioinformatics; Biomarker discovery; Cancer proteomics; Her2/neu breast cancer; Omics-based clinical assays; Splice isoforms