**Part 2**

**Diagnostics & Prognostics** 

132 Autoimmune Disorders – Current Concepts and Advances from Bedside to Mechanistic Insights

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**8** 

**Validation of Protein Biomarkers to Advance the** 

**Management of Autoimmune Disorders** 

*1Centre of Infection and Immunity, Queen's University of Belfast,* 

*5Obesity Research Center, King Saud University,* 

*1United Kingdom* 

*3Ireland 5Saudi Arabia* 

*2,4United States of America* 

*4Center for Personalized Diagnostics, Arizona State University, Tempe,* 

David S. Gibson1,2, Sorcha Finnegan1, Stephen Pennington3, Ji Qiu4, Joshua LaBaer4, Madeleine E. Rooney1 and Mark W. Duncan2,5

*2Division of Endocrinology, Metabolism and Diabetes, University of Colorado, Denver, 3Proteome Research Center, Conway Institute, University College Dublin, Dublin,* 

Despite the anticipated boom stemming from proteomic investigations, the rate at which novel protein biomarkers are introduced into clinical practice has remained static over the past 20 years. The reality is that approaches to both discover and validate protein biomarkers remain inadequate, and consequently, many areas of medicine, including the broad field of autoimmune disorders, remain deprived of the tools essential for the optimal management of patients. Most importantly, there is a huge backlog of candidate biomarkers that 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 of publications claim biomarker discoveries, there are roughly only 100 routinely used in

This chapter reviews the potential applications of protein biomarkers to manage autoimmune diseases with a special focus on the transition from the biomarker discovery through to validation phases using proteomic strategies. We emphasize the importance of careful review of the discovery data, the critical roles of protein isoform verification, and the essential features of targeted and thorough validation. Ultimately, when these factors are appropriately considered and implemented, we are optimistic that autoimmune disorders can be transformed by omics technologies and personalized practice can become a reality.

Biological markers are widely used in medicine and can provide an objective measure of normal and pathogenic processes or pharmacologic responses to a therapeutic intervention. By the term '*biological markers*' (or biomarkers) we mean an objective molecular indicator or surrogate of pathological processes which possess diagnostic, prognostic or predictive

**1.1 Biochemical markers and their potential role in autoimmune disease** 

**1. Introduction** 

clinical practice (Poste, 2011).
