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. 2013 Feb 25;4(1):7.
doi: 10.1186/1878-5085-4-7.

Pitfalls and limitations in translation from biomarker discovery to clinical utility in predictive and personalised medicine

Elisabeth Drucker  1 , Kurt Krapfenbauer
Affiliations

Pitfalls and limitations in translation from biomarker discovery to clinical utility in predictive and personalised medicine

Elisabeth Drucker et al. EPMA J. .

Abstract

Since the emergence of the so-called omics technology, thousands of putative biomarkers have been identified and published, which have dramatically increased the opportunities for developing more effective therapeutics. These opportunities can have profound benefits for patients and for the economics of healthcare. However, the transfer of biomarkers from discovery to clinical practice is still a process filled with lots of pitfalls and limitations, mostly limited by structural and scientific factors. To become a clinically approved test, a potential biomarker should be confirmed and validated using hundreds of specimens and should be reproducible, specific and sensitive. Besides the lack of quality in biomarker validation, a number of other key issues can be identified and should be addressed. Therefore, the aim of this article is to discuss a series of interpretative and practical issues that need to be understood and resolved before potential biomarkers become a clinically approved test or are already on the diagnostic market. Some of these issues are shortly discussed here.

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Figures

Figure 1
Figure 1
Clinical biomarkers: categories/types.
Figure 2
Figure 2
Overview of the relationship between publications and patenting of biomarkers.
Figure 3
Figure 3
Pitfalls and failures in biomarker identification.
See this image and copyright information in PMC

References

    1. Javle M, Hsueh CT. Recent advances in gastrointestinal oncology—updates and insights from the 2009 annual meeting of the American society of clinical oncology. J Hematol Oncol 2010. 2009;23(3):11–23. - PMC - PubMed
    1. Poste G. Bring on the biomarkers. Nature. 2011;469:156–157. doi: 10.1038/469156a. - DOI - PubMed
    1. Waerner T, Urthaler J, Krapfenbauer K. The role of laboratory medicine in healthcare: quality requirements of immunoassays, standardisation and data management in prospective medicine. EPMA J. 2010;1:619–626. doi: 10.1007/s13167-010-0053-y. - DOI - PMC - PubMed
    1. Golubnitschaja O, Costigliola V. EPMA. General reports & recommendations in predictive, preventive and personalised medicine 2012: white paper of the European Association for Predictive, Preventive and Personalised Medicine. EPMA J. 2012;3:14. doi: 10.1186/1878-5085-3-14. - DOI - PMC - PubMed
    1. Issaq HJ, Waybright TJ, Veenstra TD. Cancer biomarker discovery: opportunities and pitfalls in analytical methods. Electrophoresis. 2011;32(9):967–975. doi: 10.1002/elps.201000588. - DOI - PubMed