title: Establishing the Evidence Bar for Molecular Diagnostics in Personalised Cancer Care.
abstract: While personalised cancer medicine holds great promise, targeting therapies to the biological characteristics of patients is limited by the number of validated biomarkers currently available. The implementation of biomarkers has undergone many challenges with few biomarkers reaching cancer patients in the clinic. There have been many biomarkers that have been published and claimed to be therapeutically useful, but few become part of the clinical decision-making process due to technical, validation and market access issues. To reduce this attrition rate, there is a significant need for policy makers and reimbursement agencies to define specific evidence requirements for the introduction of biomarkers into clinical practice. Once these requirements are more clearly defined, in an analogous manner to pharmaceuticals, researchers and diagnostic companies can better focus their biomarker research and development on meeting these specific requirements, which should lead to the more rapid introduction of new molecular oncology tests for patient benefit.
authors.affiliation: Genomic Health International Sx00E0;rl, Geneva, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Schneider
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Bianchini
authors.forename: Denis
authors.initials: D
authors.lastname: Horgan
authors.forename: Stefan
authors.initials: S
authors.lastname: Michiels
authors.forename: Wim
authors.initials: W
authors.lastname: Witjes
authors.forename: Robert
authors.initials: R
authors.lastname: Hills
authors.forename: Juliette
authors.initials: J
authors.lastname: Plun-Favreau
authors.forename: Angela
authors.initials: A
authors.lastname: Brand
authors.forename: Mark
authors.initials: M
authors.lastname: Lawler
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism*; D005062:European Union; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000191:economics / Q000379:methods* / Q000592:standards*; D057054:Molecular Imaging; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000378:metabolism; D057089:Pathology, Molecular / Q000592:standards; D057285:Precision Medicine / Q000191:economics / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D014408:Biomarkers, Tumor