ABSTRACT
This chapter reviews the use of auto-antibody/antigen interactions for diagnostic assays and drug development strategies, which overcomes the technical problems and limitations of other proteomic markers. New biomarkers with improved sensitivity and specificity are required to improve disease diagnosis and prognosis. The chapter describes different technology platforms enabling the discovery and validation of biomarkers as well as the development of diagnostic assays based on novel auto-antibody/antigen interactions. Both the scientific community as well as regulatory agencies started recommending the development of diagnostic markers, assays, and tools to establish so-called companion diagnostics. The development of diagnostic markers comprises several phases from discovery to clinical assay development. Typically, the discovery process starts with high numbers of analytes tested against a low number of serum samples of cases and controls. The autoimmune profile of the human covers a huge number of auto-antibodies, which display an enormous resource to identify novel marker candidates for diagnostic purposes.
