Molecular diagnostics clinical utility strategy: a six-part framework

Expert Rev Mol Diagn. 2014 Sep;14(7):777-86. doi: 10.1586/14737159.2014.933075. Epub 2014 Aug 9.


The clinical utility of a molecular test rises proportional to a favorable regulatory risk/benefit assessment, and clinical utility is the driver of payer coverage decisions. Although a great deal has been written about clinical utility, debates still center on its 'definition.' We argue that the definition (an impact on clinical outcomes) is self-evident, and improved communications should focus on sequential steps in building and proving an adequate level of confidence for the diagnostic test's clinical value proposition. We propose a six-part framework to facilitate communications between test developers and health technology evaluators, relevant to both regulatory and payer decisions.

Keywords: clinical utility; combination diagnostics; guidelines; health technology assessment; molecular diagnostics; payers; regulatory approval.

Publication types

  • Review

MeSH terms

  • Biomedical Technology / economics*
  • Decision Making
  • Insurance, Health*
  • Molecular Diagnostic Techniques / economics*
  • Molecular Targeted Therapy / economics*
  • Precision Medicine / economics*