Nirmidas Biotech, Inc. — Department of Health and Human Services SBIR Phase II: 200

Description

Project Summary The incidence of typediabetesT Dis increasing rapidly around the worldwith prevalence expected to rise bybetweenandThe rate of T D increase is most notable in childrentoyears of ageand in individuals previously considered at lowto moderategenetic riskThis trend underscores an unmet need for T D prevention strategiesEarly identification of children at risk for pancreatic islet cell injury is our best opportunity for T D preventionIgG autoantibodies targeting islet antigensspecifically insulinGADIAand ZnTsignal pancreatic beta cell attack and are validated predictive biomarkers for T DAssays for detection of these autoantibodies are commercially available and have been used in multiple trials to predict progression to T DHoweverexpansion efforts for T D prevention have been greatly limited by the lack of a cost effectivefastreliableand widely available assay for T D autoantibodies detection in the general populationAs the most meaningful natural history and prevention studies begin their screening in very early liferequirement of small volume sample for such test will be a key consideration especially when children are concernedUsing our nanoscience based pGOLD platform which provides femtomolar sensitivity andlog dynamic range for biomarker detectionNirmidas BiotechIncaims to develop and validate a fully automatedmultiplexed assay for the diagnosis of T D with sensitivity and specificity matching the current gold standard radioimmunoassayRIAdone for clinical testin a much fastermore cost effectivelower complexitysmaller sample volume requirement and higher throughput formatExpanding on the prototype Phase I multiplexed T D assaythe general strategy for achieving the Phase II project goals is to finalize the optimization of the analytical performance of the multiplexed T D assay on pGOLD platformfollowed by clinical validation of the assay with a large carefully chosen set of T D and control samplesA fully automated system covering assay process and fluorescence reading with data acquisition analysis report will then be built and validatedwhich will facilitate FDA clearance and translation into clinical use of the pGOLD T D test