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.

糖尿病和糖尿病前期以流行病的速度增长。 Mellitus，LLC正在开发基于新型生物标志物糖基糖基糖化CD59（GCD59）的妊娠糖尿病（GDM）和糖尿病的新型测试，该测试仅获得了哈佛大学的Mellitus。 GDM在美国的年度怀孕近400万，全球130毫米活产，是一个高公共卫生的优先事项，因为这是造成不良怀孕结果的主要原因，影响了母亲和婴儿的生活。筛查和诊断基于葡萄糖耐量测试，需要多次抽血，并且对患者和从业者来说是耗时和磨损的。 Mellitus GCD59测试有可能克服这些问题。该SBIR提案详细介绍了为GDM和糖尿病开发强大的自动化测定的研究和商业计划。这些项目以概念验证数据为基础，该数据是在哈佛大学开发的学术原型测定法以及Mellitus开发的第一代手册GCD59测试的基础上生成的，该测试证明了产品概念的可行性。这些第一代GCD59测试基于使用两种抗体，即“捕获”和“检测”的三明治ELISA（酶连接的免疫吸附测定），这些抗体属于Mellitus。在第一代测试中，为了使检测抗体正常工作，需要进行基准准备步骤。结果，测试方案很复杂，不能在完全自动化的分析仪上格式化测定。 Mellitus将一支在GCD59，糖基化生物学和免疫测定开发方面具有专业知识的顶级团队汇集了介绍GCD59上的糖化结构，以便在不使用Bench Top Prep步骤的情况下使用半高度和完全自动化的分析器，以开发一套高度自动化的抗体对。计划吸引了OB/GYN从业人员和潜在的战略合作伙伴的兴趣。 SBIR第二阶段赠款的奖励将加速自动测试的开发，该测试可能成为新标准，并改善母亲和婴儿的护理以及有糖尿病风险的人。