title: Molecular diagnostics clinical utility strategy: a six-part framework.
abstract: 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.
authors.affiliation: Opus Three, LLC, 9704 Medical Center Drive, Rockville, MD 20850, USA.
authors.forename: Felix W
authors.initials: FW
authors.lastname: Frueh
authors.forename: Bruce
authors.initials: B
authors.lastname: Quinn
mesh_terms: D020811:Biomedical Technology / Q000191:economics*; D003657:Decision Making; D007348:Insurance, Health; D025202:Molecular Diagnostic Techniques / Q000191:economics*; D058990:Molecular Targeted Therapy / Q000191:economics*; D057285:Precision Medicine / Q000191:economics*
keywords: clinical utility; combination diagnostics; guidelines; health technology assessment; molecular diagnostics; payers; regulatory approval