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Corporate Overview

IsoTopics™ – July 2016

MS-based, Quantitative Plasma Proteomics | Cambridge Isotope Laboratories, Inc.

This review article provides a retrospective and prospective five-year view of quantifying human plasma proteins for biomarker development in a clinical setting. The highlighted methods are categorized under a fit-for-purpose approach (i.e., from Tier 1 to Tier 3 for clinical and exploratory assays, respectively) and primarily utilize a bottom-up methodology with stable isotope-labeled standards (at the protein or peptide level) for quantification. Discussed are the challenges, requirements, and strategies for translating candidate protein biomarkers from research to the clinic. 



Aided by the advent of advanced mass spectrometry (MS)-based technologies and methodologies, quantitative proteomics has emerged as a viable technique to capture meaningful data for candidate biomarker evaluation. To aid clinical translation, these methods generally utilize a bottom-up strategy with isotopically labeled standards and a targeted form of MS measurement.


This article reviews the status, challenges, requirements, and potential of translating current, MS-based methods to the clinical laboratory. The described methods are discussed and contrasted within a fit-for-purpose approach, while different resources for quality control, quantitative analysis, and data interpretation are additionally provided. Expert commentary: Although great strides have been made over the past five years in developing reliable quantitative assays for plasma protein biomarkers, it is crucial for investigators to have an understanding of the clinical validation process, a major roadblock in translational research. Continued progress in method design and validation of protein assays is necessary to ultimately achieve widespread adoption and regulatory approval.

Percy AJ, Byrns S, Pennington SR, Holmes DT, Anderson NL, Agreste TM, Duffy MA.

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Stable Isotope Newsletters | Cambridge Isotope Laboratories
stable isotope, stable isotope labeled compounds, environmental contaminant standards
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