Validation of Protein Biomarkers to Advance the Management of Autoimmune Disorders

Despite the anticipated boom stemming from proteomic investigations, the rate at whichnovel protein biomarkers are introduced into clinical practice has remained static over thepast 20 years. The reality is that approaches to both discover and validate proteinbiomarkers remain inadequate, and consequently, many areas of medicine, including thebroad field of autoimmune disorders, remain deprived of the tools essential for the optimalmanagement of patients. Most importantly, there is a huge backlog of candidate biomarkersthat are yet to undergo thorough investigation and validation to assess their clinical utility.A recent assessment of the situation has estimated that although many tens of thousands ofpublications claim biomarker discoveries, there are roughly only 100 routinely used inclinical practice (Poste, 2011).This chapter reviews the potential applications of protein biomarkers to manageautoimmune diseases with a special focus on the transition from the biomarker discoverythrough to validation phases using proteomic strategies. We emphasize the importance ofcareful review of the discovery data, the critical roles of protein isoform verification, and theessential features of targeted and thorough validation. Ultimately, when these factors areappropriately considered and implemented, we are optimistic that autoimmune disorderscan be transformed by omics technologies and personalized practice can become a reality.