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Open Access Commentary

The failure of protein cancer biomarkers to reach the clinic: why, and what can be done to address the problem?

Eleftherios P Diamandis

Author affiliations

Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON, Canada

Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada

Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada

Citation and License

BMC Medicine 2012, 10:87  doi:10.1186/1741-7015-10-87

Published: 9 August 2012

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.

Keywords:
biomarker failures; biomarker validation; cancer biomarkers; false discovery; improved biomarkers; proteomics