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

Molecular diagnostics clinical utility strategy: a six-part framework.

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Opus Three, LLC, 9704 Medical Center Drive, Rockville, MD 20850, USA.


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.


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

[Indexed for MEDLINE]

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