Serum biomarker discovery in early onset type 2 diabetes

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DESCRIPTION (provided by applicant): Our ultimate goal is to develop and commercialize new, sensitive, specific, non-invasive and "user-friendly" immunodiagnostic assays based on patients' serum for the early detection of type 2 diabetes. These assays, that would not require fasting or glucose administration, would improve diagnosis, disease progression, and management. Overall, they would facilitate early population screening and prevention for this disease affecting over 6% of the US adult population, with increasing incidence in our younger population. In this SBIR Phase I project we propose to apply proprietary technologies to identify biomarkers for the early detection of type 2 diabetes. Our innovative antibody-based approach involves: i) a collection of polyclonal antibodies raised against known and unknown human proteins; and ii) a proprietary protein array allowing multiplex analysis of a large number of clinical samples using a large number of antibodies. Phase I research will focus on the comparative analysis of serum protein expression profiles between prediabetes, type 2 diabetes patients, and normal controls using a large number of antibodies from our collection. Statistical analysis of the data points generated in this study will enable us to select antibodies that discriminate pre-diabetes and type 2 diabetes with respect to normal. Selected antibodies will be further validated in Phase II, leading to the development of specific biomarkers and immunodiagnostic assays for the early detection of type 2 diabetes.