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

项目摘要 1型糖尿病（T1D）影响美国约150万人，是美国第二大常见慢性疾病。 孩子T1D的发生是由于免疫系统对胰腺的错误攻击。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 在临床T1D症状发展之前很久就存在于血液中，并作为理想的生物标志物， T1D的早期诊断大型临床试验已经证明，筛查儿童的T1D自身抗体是一种有效的方法。 减少危及生命的酮症酸中毒发作的有效方法。而且，这些患者可以用一种新的 药物（替利珠单抗），平均延迟2.8年的胰岛素依赖发作。这些最近 发展表明，对儿童进行人口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将需要数百万的T1D自身抗体测试进行 每年仅在美国。这一壮举是目前的测试技术所无法达到的，目前的测试技术速度慢，成本高， 并且需要集中的实验室设施。这个问题的唯一可能解决方案是床旁T1D 自身抗体检测，但迄今为止的即时检测缺乏必要的分析性能。 在这个I期项目中，Electronic BioSciences，Inc.将根据最新进展开发T1D检测 在纳米孔技术中，快速检测一组最临床相关的T1D自身抗体， 关怀格式FiND技术的一个关键方面是其高度复用的能力，这将允许新的 T1D自身抗体生物标志物将在发现和验证时添加到面板中，这将进一步 提高检测的诊断和预后能力。拟议的低成本、高性能T1 D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.