title: The pathway to clinical use of a cancer biomarker.
abstract: Biomarkers play a key role in the diagnosis and management of patients with cancer, and are important for fulfilling the promise of precision medicine in oncology. However, although numerous biomarkers have been shown to have clinical validity, many have not undergone rigorous testing to demonstrate clinical utility so that they can be appropriately incorporated into clinical care. This review article highlights the characteristics of a good biomarker and the steps required to demonstrate clinical utility, and gives examples of both successful established biomarkers and promising new tissue-based and circulating biomarkers on the horizon.
authors.affiliation: a University of Michigan , Ann Arbor , MI , USA.
authors.forename: N Lynn
authors.initials: NL
authors.lastname: Henry
mesh_terms: D060890:B7-H1 Antigen / Q000235:genetics / Q000378:metabolism; D014408:Biomarkers, Tumor / Q000235:genetics* / Q000378:metabolism; D002986:Clinical Trials as Topic; D004273:DNA, Neoplasm / Q000097:blood / Q000235:genetics; D047628:Estrogen Receptor alpha / Q000235:genetics / Q000378:metabolism; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D009360:Neoplastic Cells, Circulating / Q000378:metabolism / Q000473:pathology; D057285:Precision Medicine / Q000295:instrumentation / Q000379:methods*; D048493:Proto-Oncogene Proteins B-raf / Q000235:genetics / Q000378:metabolism; D012107:Research Design; D000509:alpha-Fetoproteins / Q000235:genetics / Q000378:metabolism
chemical_list: C097353:AFP protein, human; D060890:B7-H1 Antigen; D014408:Biomarkers, Tumor; C423236:CD274 protein, human; D004273:DNA, Neoplasm; C506487:ESR1 protein, human; D047628:Estrogen Receptor alpha; D000509:alpha-Fetoproteins; C482119:BRAF protein, human; D048493:Proto-Oncogene Proteins B-raf
keywords: Circulating tumor cell; circulating tumor DNA; clinical utility; prospective