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

BMC Med. 2012 Aug 9;10:87. doi: 10.1186/1741-7015-10-87.


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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Biomarkers, Tumor / blood*
  • Biomedical Research
  • Biotechnology
  • Diagnostic Techniques and Procedures
  • Humans
  • Neoplasm Proteins / blood*
  • Neoplasms / blood*
  • Neoplasms / diagnosis*
  • Reproducibility of Results
  • Translational Medical Research


  • Biomarkers, Tumor
  • Neoplasm Proteins