The incidence of type 1 diabetes (T1D) is increasing rapidly around the world, with prevalence expected to rise by 150 % between 2010 and 2025. The rate of T1D increase is most notable in children 0 to 4 years of age, and in individuals previously considered at low- to moderate- genetic risk. This trend underscores an unmet need for T1D prevention strategies. Early identification of children at-risk for pancreatic islet cell injury is our best opportunity for T1D prevention. IgG autoantibodies targeting islet antigens (specifically insulin, GAD, IA-2 and ZnT8) signal pancreatic beta cell attack and are validated predictive biomarkers for T1D. Assays for detection of these autoantibodies are commercially available and have been used in multiple trials to predict progression to T1D. However, expansion efforts for T1D prevention have been greatly limited by the lack of a cost-effective, fast, reliable, and widely available assay for T1D autoantibodies detection in the general population. As the most meaningful natural history and prevention studies begin their screening in very early life, requirement of small volume sample for such test will be a key consideration especially when children are concerned. Using our nanoscience based pGOLD platform which provides femtomolar sensitivity and 6-log dynamic range for biomarker detection, Nirmidas Biotech. Inc.
aims to develop and validate a fully automated, multiplexed assay for the diagnosis of T1D with sensitivity and specificity matching the current gold standard radioimmunoassay (RIA) done for clinical test, in a much faster, more cost-effective, lower complexity, smaller sample volume requirement and higher throughput format. Expanding on the prototype Phase I multiplexed T1D assay, the general strategy for achieving the Phase II project goals is to finalize the optimization of the analytical performance of the multiplexed T1D assay on pGOLD platform, followed by clinical validation of the assay with a large carefully chosen set of T1D and control samples. A fully automated system covering assay process and fluorescence reading with data acquisition/analysis/report will then be built and validated, which will facilitate FDA clearance and translation into clinical use of the pGOLD T1D test.
Over three decades of research efforts involving over millions of individuals have demonstrated that T1D associated autoantibodies are diagnostic, and asymptotic children with multiple autoantibodies progress to symptomatic diabetes at a rate approximating 11% per year. Although initial study results highlighted improved T1D prevention with earlier diagnosis and initiation of therapy, these efforts are hampered by the non-availability of cost-effective T1D assays for identification of patients most likely to develop type 1 diabetes in the future. To provide better diagnostic tools for the T1D diagnosis and asymptotic population-based screening, we aim to develop and validate a fully automated, rapid, multiplexed T1D autoantibody assay, which matches the performance of current gold standard clinical test, and is cost-effective, easy to use, and requires small sample volume.
