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Clin Chem. 2002 Aug;48(8):1147-50.

Cancer biomarkers: easier said than done.

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  • 1Department of Laboratory Medicine and Pathobiology and Surgery, University of Toronto, Ontario, M5G 1X5 Canada.



Biological and technical advances have led to greatly increased research and development of cancer biomarkers. This overview lists some of the challenges and barriers to developing novel effective cancer biomarkers and enablers to facilitate cancer biomarker development.


Current scientific literature regarding development of biomarkers for cancer and other diseases was reviewed.


Challenges to developing cancer biomarkers include better understanding of biological heterogeneity, including host/tumor heterogeneity; analytical factors, such as interferences and analytical sensitivity; clinical pathologic factors, such as current histopathologic standards; and health service and market factors. More standardized biomarker definitions, standardization of cancer biology terminology, and high-quality reference materials (specimen and clinical data repositories) were identified as factors required to support advances in cancer biomarkers.


With the above enablers, novel cancer biomarkers may be useful, both for assessing early and established neoplasia more precisely and for contributing data toward development of novel practical concepts regarding cancer biology.

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