title: Validation of new cancer biomarkers: a position statement from the European group on tumor markers.
abstract: BACKGROUND
  Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.
  
  
  BACKGROUND
  In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study.
  
  
  CONCLUSIONS
  Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit.
authors.affiliation: Clinical Research Centre, St Vincent's University Hospital and UCD School of Medicine and Medical Science, Conway Institute of Bimolecular and Biomedical Research, University College Dublin, Dublin, Ireland; michael.j.duffy@ucd.ie.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Duffy
authors.affiliation: Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom;
authors.forename: Catharine M
authors.initials: CM
authors.lastname: Sturgeon
authors.affiliation: Department of Clinical Biochemistry, University of Copenhagen North Zealand Hospital, Hillerød, Denmark;
authors.forename: György
authors.initials: G
authors.lastname: Sölétormos
authors.affiliation: Oncology Department, Hadassah University Hospital, Jerusalem, Israel;
authors.forename: Vivian
authors.initials: V
authors.lastname: Barak
authors.affiliation: Hospital Clinic, University of Barcelona, Barcelona, Spain;
authors.forename: Rafael
authors.initials: R
authors.lastname: Molina
authors.affiliation: University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.affiliation: Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada;
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Diamandis
authors.affiliation: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Patrick M M
authors.initials: PM
authors.lastname: Bossuyt
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D019963:Clinical Chemistry Tests; D005060:Europe; D019981:Health Care Sector; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis*; D010865:Pilot Projects; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods
chemical_list: D014408:Biomarkers, Tumor