On best practices: The Institute of Medicine scheme for developing, validating, and demonstrating clinical utility of omics-based diagnostic and predictive tests


  • Gilbert S. Omenn

    Corresponding author
    1. Departments of Computational Medicine and Bioinformatics, Internal Medicine, and Human Genetics, School of Public Health, University of Michigan, Ann Arbor, MI, USA
    2. Institute for Systems Biology, Seattle, WA
    • Correspondence: Dr. Gilbert S. Omenn, Department of Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, MI 48109-2218, USA

      E-mail: gomenn@umich.edu

      Fax: +1-734-615-6553

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  • Colour Online: See the article online to view Figs. 1 and 2 in colour.


The Institute of Medicine of the US National Academy of Sciences issued a major report in 2012 that provides important guidance for the proteomics community for credible and transparent development of all kinds of omics-based diagnostic and prognostic tests. The key elements are summarized here to provide a compass that can guide the studies emerging from many laboratories as reported in this special issue of Proteomics Clinical Applications on “Diagnostic Proteomics.”