An automated test for gestational diabetes based on glycated CD59

糖尿病和糖尿病前期正在以流行病的速度增长。Mellitus，LLC正在开发一种基于新型生物标志物糖化CD 59（GCD 59）的妊娠糖尿病（GDM）和糖尿病的新型检测方法，该生物标志物由哈佛大学独家授权给Mellitus。美国每年有近400万例妊娠，全球有1.3亿例活产，GDM是一个高度优先的公共卫生问题，因为它是不良妊娠结局的主要原因，影响母亲和婴儿的生活。筛查和诊断是基于葡萄糖耐量测试，需要多次抽血，对患者和从业人员来说既耗时又繁重。糖尿病GCD 59检测有可能克服这些问题。该SBIR提案详细说明了开发GDM和糖尿病稳健自动化检测方法的研究和商业计划。这些项目建立在概念验证数据的基础上，这些数据是在哈佛大学开发的学术原型分析和由Mellitus开发的第一代手动GCD 59测试中生成的，这些数据证明了产品概念的可行性。这些第一代GCD 59测试是基于夹心ELISA（酶联免疫吸附试验），使用两种抗体，“捕获”和“检测”，这是专有的Mellitus。在第一代检测中，需要一个工作台准备步骤，以使检测抗体正常工作。因此，测试协议是复杂的，并且测定不能在全自动分析仪上格式化。Mellitus汇集了一个在GCD 59，糖化生物学和免疫测定开发方面具有专业知识的顶级团队，以表征GCD 59上的糖化结构，以开发一套可用于半自动和全自动分析仪的新型高特异性抗体对，而无需台式制备步骤。该计划吸引了OB/GYN从业人员和潜在战略合作伙伴的兴趣。SBIR第二阶段赠款的授予将加速自动化测试的开发，该测试可能成为新的标准，并改善对母亲和婴儿以及全球糖尿病风险人群的护理。

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.