Urine glycated CD59 as novel diabetes biomarker amenable to measure with a point-of-care device

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Project Abstract Diabetes and pre-diabetes are a high public health priority worldwide because they represent a major cause of morbidity and mortality in the adult population, and both are growing at an epidemic rate around the globe. Diabetes and pre-diabetes currently affect close to 9% of the world population and it is estimated that the global prevalence will increase almost 50% over the next 20 years. Mellitus, LLC is developing a novel test for screening, diagnosis and monitoring individuals with diabetes, pre-diabetes and gestational diabetes (GDM). The test is based on the novel biomarker glycated CD59 (GCD59), which was licensed exclusively by Mellitus from Harvard University. Important features of the biomarker are that it 1) is pathogenically relevant because of its mechanistic link to the development of diabetic complications, 2) is present not only in blood but also in urine and other bodily fluids, and 3) has a turn-over rate of ~2 weeks, which is much faster than HbA1c. Mellitus has already developed an ELISA (Enzyme Linked Immunosorbent Assay) test for blood levels of GCD59 and is now in the process of developing a new test to measure urine levels of GCD59 in a point-of-care (POC) format. A POC urine test for GCD59 has the potential to revolutionize the field of diabetes because it will provide physician and patients a simple, accurate, pathogenically relevant and easy to use diagnostic test to 1) efficiently screen and diagnose diabetes, pre-diabetes and GDM, 2) monitor treatment effectiveness and 3) assess the risk of developing the devastating and life-threatening complications of these conditions. This SBIR Direct to Phase II proposal details the plan to develop a robust POC test for urine GCD59. The project builds on extensive proof-of-concept data generated with the academic prototype plasma assay developed at Harvard University and the first-generation manual GCD59 test developed by Mellitus, which together demonstrate feasibility for the product concept. Two proprietary antibodies have been developed to provide a quantitative estimate of the urine GCD59/total CD59 ratio. These valuable reagents have been used in preliminary studies to assess the feasibility and potential clinical utility of the urine GCD59 test that Mellitus proposes to develop in this application. Mellitus has brought together a top- tier team with expertise in GCD59, glycation biology and point-of-care assay development to develop a novel, easy-to-use, accurate and reliable POC test to measure GCD59 levels in urine. This program has attracted the interest of practitioners as well as national and international potential strategic partners. Award of an SBIR Phase II grant would accelerate development of a urine GCD59 test that could potentially become the new standard for screening, diagnosing and monitoring diabetes for the benefit of populations worldwide.