The World Health Organization projects that the global diabetes cases will increase from 217 million in 2005 to 366 million by 2030 [1]. The rate of type-1 or autoimmune diabetes (T1D) in children is rising by 3% annually with a projected 70% increase between 2004 and 2020, while the rate of type-2 diabetes (T2D) has also been increasing exponentially in children partly due to the global obesity epidemic. Diagnosis of these diseases has become increasingly difficult. Currently, T1D 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 T1D diagnosis in 24 hours or less in some cases. Due to the need for radioisotope generation and detection, the T1D 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-2 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 T1D 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 ~ 15 - 30% T1D patients and Celiac Disease occurs in 4 - 9% of T1d patients. We propose to develop and clinically test a multiplexed auto-immune antibody chip with simultaneous diagnosis of T1D, 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 patient's serum that indicate T1D, Celiac Disease, and ATD with the same performance as RIA in just 1-2 hours. This project will test the pGOLD chip with 150 patient serum samples as a pilot study as the initial step towards gaining regulatory approval and commercialization of the chip.
The World Health Organization projects that the global diabetes cases will increase from 217 million in 2005 to 366 million by 2030, while accurately distinguishing Type 1 Diabetes from Type 2 Diabetes will become increasing difficult over that same time frame using epidemiologic assumptions. The gold standard test for differentiation of Type 1 and Type 2 Diabetes is radioimmunoassay, which takes up to two weeks and delays proper patient treatment. Nirmidas Biotech's patented fluorescence-amplifying technology will improve Type 1 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 1 Diabetes.
