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Methods for Biomarker Verification and Assay Development

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Abstract:

Recent advances in global-scale proteomic technology enable identification of hundreds of candidate biomarkers. However, very few candidates so identified can reach the high bar of FDA approval for clinical use. The low efficiency of biomarker approval reflects the challenges of taking candidate biomarkers identified in discovery research through the long and difficult pipeline required for biomarker development. The greatest challenge in biomarker development is the lack of reliable assays for use in the verification and validation phases. This paper reviews methodologies and challenges for biomarker assay development with emphasis on stable isotope dilution coupled with multiple reaction monitoring-mass spectrometry (SID-MRM-MS). Because of its sensitivity, quantification abilities, and specificity, SIDMRM- MS has the potential to bridge the critical rate-limiting gaps between the biomarker discovery- and validation phases. A workflow for generation of a specific SID-MRM-MS assay is presented. We conclude that currently, SIDMRM- MS assay is a promising technology for biomarker verification and validation. To move the technology toward an FDA-approvable platform, more stringent evaluation must be performed and these future studies will require a joint effort of the clinical proteomics community, the regulatory agency and major mass spectrometer manufacturers.





Keywords: Chronic obstructive pulmonary disease; Coefficient of variation; Concatemer of isotope-labeled marker peptides; Enzyme-linked immunosorbent assay; Mass spectrometry; Multiple reaction monitoring; Stable isotope dilution; Stable isotope labeled internal standard; Stable isotope standards and capture by anti-peptide antibodies; Tandem mass spectrometry; assay development; biomarker verification; multiple reaction monitoring; proteomics; stable isotope dilution

Document Type: Research Article

DOI: https://doi.org/10.2174/157016411795678066

Publication date: 2011-07-01

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  • Current Proteomics research in the emerging field of proteomics is growing at an extremely rapid rate. The principal aim of Current Proteomics is to publish well-timed review articles in this fast-expanding area on topics relevant and significant to the development of proteomics. Current Proteomics is an essential journal for everyone involved in proteomics and related fields in both academia and industry.
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