The failure of protein cancer biomarkers to reach the clinic: why, and what can be done to address the problem?
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
BMC Medicine 2012, 10:87 doi:10.1186/1741-7015-10-87Published: 9 August 2012
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.