Point-of-Care Assay for Type 1 Diabetes Diagnosis and Prognostication

项目摘要 1型糖尿病(T1D)在美国影响着约150万人，是美国第二大最常见的慢性病 孩子们。T1D的发生是免疫系统对胰腺的错误攻击的结果。自身抗体 胰岛抗原是T1D自身免疫的副产物，是T1D的有效生物标志物。他们是 早在临床T1D症状出现之前就存在于血液中，是诊断T1D症状的理想生物标志物 T1D的早期诊断。大型临床试验已经证明，筛查儿童T1D自身抗体是一种 减少酮症酸中毒危及生命的有效方法。而且，这些患者可以用一种新的 药物(替普利单抗)，它将胰岛素依赖的发生平均推迟2.8年。这些最近的 事态发展表明，对儿童进行人群水平的筛查具有明显的医疗和社会效益 T1D自身抗体，但这一有价值的目标需要进行数百万次T1D自身抗体检测 每年仅在美国一地。这一壮举是目前的测试技术所无法企及的，目前的测试技术缓慢、昂贵， 并且需要集中的实验室设施。解决此问题的唯一可能的解决方案是护理点T1D 自身抗体检测，然而，到目前为止，护理点检测缺乏必要的分析性能。 在这个第一阶段的项目中，电子生物科学公司将根据最新的发展开发一种T1D检测方法 在纳米孔技术中，为了快速检测一组临床上最相关的T1D自身抗体 CARE格式。Find技术的一个关键方面是其高度多路复用的能力，这将允许新的 T1D自身抗体生物标记物将在发现和验证时添加到试剂盒中，这将进一步 提高检测的诊断和预后能力。建议的低成本、高性能、T1D测试 是人群水平T1D筛查的理想解决方案。

Project Summary Type 1 diabetes (T1D) affects ~1.5 million people in the US and is the second most common chronic illness in children. T1D occurs as the result of a mistaken attack by the immune system on the pancreas. Autoantibodies to pancreatic islet antigens, a byproduct of T1D autoimmunity, are well-validated biomarkers for T1D. They are present in blood long before the development of clinical T1D symptoms, and serve as ideal biomarkers for the early diagnosis of T1D. Large clinical trials have proven that screening children for T1D autoantibodies is an effective way to reduce life-threatening episodes of ketoacidosis. And, these patients can be treated with a new drug (teplizumab), which delays the onset of insulin dependence by an average of 2.8 years. These recent developments demonstrate the obvious medical and social benefits of population-level screening of children for T1D autoantibodies, but this worthy goal would require many millions of T1D autoantibody tests to be performed each year in the US alone. This feat is out of reach with current testing technology, which is slow, expensive, and requires centralized laboratory facilities. The only possible solution to this problem is a point-of-care T1D autoantibody test, yet point-of-care tests to date have lacked the necessary analytical performance. In this Phase I project, Electronic BioSciences, Inc. will develop a T1D assay, based on the latest developments in nanopore technology, to rapidly detect a panel of the most clinically relevant T1D autoantibodies in a point-of- care format. A key aspect of the FiND technology is its capacity to be highly multiplexed, which will allow new T1D autoantibody biomarkers to be added to the panel as they are discovered and validated, which will further improve the diagnostic and prognostic capability of the test. The proposed low cost, high performance, T1D test is the ideal solution for population-level T1D screening.