An automated test for gestational diabetes based on glycated CD59

基于糖化 CD59 的妊娠糖尿病自动化检测

• 批准号: 9909653
• 负责人: Chris Pacheco
• 金额: $ 75.06万
• 依托单位: MELLITUS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909653
• 关键词: Amino Acids; Antibodies; Automation; Award; Biological Assay; Biology; Biotechnology; Blood; Caring; Child; Childbirth; Clinical; Complex; Consumption; Data; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Early Diagnosis; Ensure; Enzyme-Linked Immunosorbent Assay; Epidemic; Event; Generations; Gestational Diabetes; Glucose tolerance test; Goals; Grant; Human; Hybridomas; Immunoassay; Institutes; Kinetics; Length; Live Birth; Lysine; Manuals; Metabolic; Methodology; Monoclonal Antibodies; Mothers; Patients; Phase; Plasma; Pre-Eclampsia; Prediabetes syndrome; Pregnancy; Pregnant Women; Process; Proteins; Protocols documentation; Reagent; Recombinant Antibody; Recombinants; Research; Running; Sampling; Small Business Innovation Research Grant; Structure; Testing; Time; Universities; Work; adverse pregnancy outcome; anticancer research; assay development; base; case control; circulating biomarkers; commercialization; delivery complications; diabetes risk; diabetic patient; diagnostic assay; glucose production; glycation; high throughput screening; improved; insulin secretion; interest; negative affect; novel; novel marker; programs; prototype; public health priorities; screening; synthetic peptide; validation studies

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.

糖尿病和前驱糖尿病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CD59 （GCD59）的妊娠糖尿病（GDM）和糖尿病的新型检测方法，该方法由哈佛大学独家授权给Mellitus公司。美国每年有近400万例怀孕，全世界有130万例活产，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命。筛查和诊断基于葡萄糖耐量测试，需要多次抽血，对患者和医生来说既耗时又繁重。糖尿病GCD59测试有可能克服这些问题。该SBIR提案详细介绍了开发一种强大的、自动化的GDM和糖尿病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，这些数据是由哈佛大学开发的学术原型分析和Mellitus开发的第一代手册GCD59测试产生的，这些数据证明了产品概念的可行性。这些第一代GCD59测试基于夹心ELISA（酶联免疫吸附试验），使用两种抗体，“捕获”和“检测”，这是Mellitus专有的。在第一代测试中，为了使检测抗体正常工作，需要一个工作台准备步骤。因此，测试方案是复杂的，化验不能在全自动分析仪上格式化。Mellitus汇集了具有GCD59，糖基化生物学和免疫分析开发专业知识的顶级团队，以表征GCD59上的糖基化结构，以开发一套新的高特异性抗体对，可用于半自动和全自动分析仪，无需台式准备步骤。该项目吸引了妇产科医生和潜在战略合作伙伴的兴趣。SBIR二期拨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，并改善全球母亲和婴儿以及糖尿病高危人群的护理。