Industrialized MS-based proteomics in the search for circulating biomarkers

Proteomics is the study of the expression, structure and function of proteins under a range of cellular conditions. A rapidly evolving component of this field is clinical proteomics, which focuses on proteins involved in human disease and how they are affected by therapeutic intervention. MS is the main analytical technology for identifying and quantifying proteins whose expression is modulated across the normal to disease continuum. Applying this technology to clinical samples, however, is particularly challenging due to high biological variability in the population, a variety of disease stages, nonuniform response to therapy, multiple concomitant treatments and special requirements for handling samples from clinical trials. Given these challenges, an 'industrialized' approach is best suited to clinical biomarker development, with its standard operating procedures, process control and 'chain of custody'. This review will focus, therefore, on MS-based industrialized proteomics for the discovery and verification of circulating candidate clinical protein biomarkers.