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Open Access Review

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

Elisabeth Drucker1 and Kurt Krapfenbauer2*

Author Affiliations

1 Department of Molecular Biotechnology, University of Applied Science Vienna, Helmut-Qualtinger-Gasse 2, Vienna A-1030, Austria

2 Department of Otorhinolaryngology, Medical University of Vienna, Head and Neck Surgery, Waehringer Guertel 18-20, Vienna A-1090, Austria

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EPMA Journal 2013, 4:7  doi:10.1186/1878-5085-4-7

Published: 25 February 2013

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.

Keywords:
Predictive medicine; Targeted prevention; Validation strategies; Regulatory overview; Biomarker perspectives; Tailored therapy