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

Description

DESCRIPTION provided by applicant The World Health Organization projects that the global diabetes cases will increase from million in to million by The rate of type or autoimmune diabetes T D in children is rising by annually with a projected increase between and while the rate of type diabetes T D has also been increasing exponentially in children partly due to the global obesity epidemic Diagnosis of these diseases has become increasingly difficult Currently T D diagnosis and screening tests for new on set patients are done by slow and costly radioimmunoassay RIA delaying definitive diagnosis and timely treatment The RIA test may take up to two weeks to deliver a diagnosis but clinical intervention is needed for T D diagnosis in hours or less in some cases Due to the need for radioisotope generation and detection the T D test is inaccessible to developing countries and regions of the world with limited resources Also latent autoimmune diabetes adults LADA cases with positive autoantibodies are common accounting for a non trivial fraction of adult type diabetes patients Antibodies testing and screening for adult diabetes patients would also provide valuable information and guidance to LADA patient management and treatment Of note with T D there is a markedly higher prevalence of Celiac Disease and Autoimmune Thyroid Disease ATD which are considered linked diseases In US autoimmune thyroid disease occurs in T D patients and Celiac Disease occurs in of T d patients We propose to develop and clinically test a multiplexed auto immune antibody chip with simultaneous diagnosis of T D Celiac Disease and ATD The chip will provide a rapid fluorescence based diagnostic test using existing instrumentation found in the clinic made possible by the unique signal enhancing technology pGOLD available to Nirmidas Biotech The pGOLD chip will detect autoantibodies in a patientandapos s serum that indicate T D Celiac Disease and ATD with the same performance as RIA in just hours This project will test the pGOLD chip with patient serum samples as a pilot study as the initial step towards gaining regulatory approval and commercialization of the chip PUBLIC HEALTH RELEVANCE The World Health Organization projects that the global diabetes cases will increase from million in to million by while accurately distinguishing Type Diabetes from Type Diabetes will become increasing difficult over that same time frame using epidemiologic assumptions The gold standard test for differentiation of Type and Type Diabetes is radioimmunoassay which takes up to two weeks and delays proper patient treatment Nirmidas Biotechandapos s patented fluorescence amplifying technology will improve Type Diabetes detection by making it more rapid and versatile We will develop a multiplexed fluorescence assay based chip with the same effectiveness as radioimmunoassay but with a turn around time of only a few hours and the additional capability to diagnose Celiac Disease and Autoimmune Thyroid Disease which are commonly associated with Type Diabetes