title: The failure of protein cancer biomarkers to reach the clinic: why, and what can be done to address the problem?
abstract: There is a plethora of published cancer biomarkers but the reality is that very few, if any, new circulating cancer biomarkers have entered the clinic in the last 30 years. I here try to explain this apparent oxymoron by classifying circulating cancer biomarkers into three categories: fraudulent reports (rare); true discoveries of biomarkers, that then fail to meet the demands of the clinic; and false discoveries, which represent artifactual biomarkers. I further provide examples of combinations of some known cancer biomarkers that can perform well in niche clinical applications, despite individually being not useful.
authors.affiliation: Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON, Canada. ediamandis@mtsinai.on.ca
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Diamandis
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D035843:Biomedical Research; D001709:Biotechnology; D019937:Diagnostic Techniques and Procedures; D006801:Humans; D009363:Neoplasm Proteins / Q000097:blood*; D009369:Neoplasms / Q000097:blood* / Q000175:diagnosis*; D015203:Reproducibility of Results; D057170:Translational Research, Biomedical
chemical_list: D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins