Genalyte will demonstrate the feasibility of our bio-sensing instrument platform for rapid sensitive high- throughput and low cost multiplexed panels to identify and monitor immune status for Type 1 Diabetes (T1D) auto-antibodies. The key to this capability is a proprietary label-free sensor based on silicon photonics chip technology. This sensor array is low cost, compact, mass manufacturable, and sensitive. Coupled with a real-time scanning instrumentation, specimens of serum (typically 25L) are sampled from a 96 well plate and introduced to the chip where they are read immediately, with simultaneous results for up to 128 analytes. The goal of this application is to devise and generate a novel multiplex assay for the detection and profiling of autoantibody responses associated with T1D. A two tier approach will involve first creating a basic multiplex assay to detect autoimmune response for known targets for T1D. Second, we will explore the analytical capability of the system with an expanded multiplexing to epitope map antibody binding across regions of the antigen as well as developing methods to assess autoantibody affinity. The ability to profile autoantibody response by multiple criteria will enhance our ability to detect and monitor disease development. PUBLIC HEALTH RELEVANCE: Project Narrative Genalyte has developed a novel bio-sensing instrument platform for rapid, sensitive, high-throughput, low cost, analysis of blood proteins, requiring minimal sample preparation. We propose to use this to generate a novel, multiplexed assay for T1D that will measure autoantibody load, target specificity, and affinity, as a means to profile immune response through the course of disease progression.