Identifying Clinically Relevant Proteins for Targeted Analysis in the Development of a Multiplexed Proteomic Biomarker Assay.

In recent years, hundreds of candidate protein biomarkers have been identified using discovery-based proteomics. Despite the large number of candidate biomarkers, few proteins advance to clinical validation. Here, we describe a hypothesis driven approach to identify candidate biomarkers, previously characterized in the literature, with the highest probability of clinical applicability. A ranking method, the hypothesis directed biomarker ranking (HDBR) system, was developed to score candidate biomarkers based on seven criteria deemed important in the selection of clinically useful biomarkers. The HDBR system was initially applied to identify candidate biomarkers for the development of a diagnostic test for the early detection of colorectal cancer, but this system can be widely applied to identify biomarkers of relevance in different disease states, for diagnosis, prognostication, or any other specific purpose.