An automated test for gestational diabetes based on glycated CD59

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Diabetes and pre-Diabetes are growing at an epidemic rate. Mellitus, LLC is developing a novel test for Gestational Diabetes (GDM) and Diabetes based on the novel biomarker, Glycated CD59 (GCD59), licensed exclusively to Mellitus from Harvard University. With nearly 4M annual pregnancies in the US and 130MM live births worldwide, GDM is a high public health priority because it is a major cause of adverse pregnancy outcomes, impacting the lives of mother and baby. Screening and diagnosis is based on glucose tolerance testing that requires multiple blood draws and is time consuming and burdensome for patients and practitioners. The Mellitus GCD59 Test has the potential to overcomes these issues. This SBIR proposal details the research and commercial plan to develop a robust, automated assay for GDM and Diabetes. The projects build on proof-of-concept data, generated on the academic prototype assay developed at Harvard University and the first-generation manual GCD59 test developed by Mellitus, that demonstrates feasibility for the product concept. These first-generation GCD59 Tests are based on a sandwich ELISA (Enzyme Linked Immunosorbent Assay) that uses two antibodies, “capture” and “detection”, that are proprietary to Mellitus. In the first-generation tests, a bench top prep step is required in order for the detection antibody to work properly. As a result, the testing protocols are complex and the assay cannot be formatted on a fully-automated analyzer. Mellitus has brought together a top-tier team with expertise in GCD59, glycation biology and immunoassay development to characterize the glycation structures on GCD59 in order to develop a novel set of highly-specific antibody pairs that can be used on semi- and fully automated analyzers without a bench top prep step. This program has attracted the interest of OB/GYN practitioners and potential strategic partners. Award of an SBIR Phase II grant would accelerate development of an automated test which could become the new standard and improve the care of mothers and babies and people at risk for diabetes worldwide.