Nanowire Sensor Array-based Assay for Early Diagnosis of Alzheimer's Disease

描述（由申请人提供）：目前据信超过500万美国人患有阿尔茨海默病（AD），这是最常见的痴呆症。到2050年，这一数字可能达到1600万。AD是一种晚期的、进行性的脑部疾病，没有已知的病因或治愈方法。AD导致记忆丧失、意识模糊、判断力受损、人格改变、定向障碍和无法交流。阿尔茨海默氏症协会估计，45万人将死于阿尔茨海默氏症，这意味着他们将在患上这种疾病后死亡。2013年，美国的医疗费用估计为2030亿美元。此外，1540万美国人为阿尔茨海默氏症和其他形式的痴呆症患者提供价值2160亿美元的无偿护理。目前，除了尸检外，没有明确的临床诊断AD。由于早期诊断可以实现更好的计划和协调的护理，因此迫切需要开发一种具有成本效益，高度敏感和选择性的AD早期诊断工具。InnoSense LLC（ISL）旨在开发一种基于高灵敏度微电子生物传感器阵列（Adnos）的检测系统，通过检测一组普遍接受的AD相关蛋白质生物标志物，提供快速、可靠和灵敏的AD早期诊断。在第一阶段，我们的目标是通过明确检测脊髓液样品中纳摩尔至皮摩尔水平的AD蛋白生物标志物来证明Adnos测试系统的性能。ISL将生长纳米线，结合抗体，创建位点特异性阵列，并研究与测定相关的问题，包括以下内容：（1）特异性和非特异性结合，（2）响应时间，（3）测定 体积，（4）灵敏度、准确度和测量精度，以及（5）信噪比。该Adnos系统将具有以下广泛的社会经济效益：（1）在医生办公室、诊所和医院中的易于使用和成本有效的护理点测试，（2）通过可以由医疗保健提供者管理的多功能预后/诊断测试改善和可靠的患者护理，（3）用于研究非AD痴呆和神经疾病和病症的有价值的研究工具，以及（4）用于制药/生物技术工业、政府和学术界的新的基于免疫测定的研究工具。

DESCRIPTION (provided by applicant): Over 5 million Americans are currently believed to have Alzheimer's disease (AD), the most common form of dementia. This number could reach 16 million by 2050. AD is a terminal, progressive brain disorder with no known cause or cure. AD leads to memory loss, confusion, impaired judgment, personality changes, disorientation, and the inability to communicate. The Alzheimer's Association estimates that 450,000 people will die with Alzheimer's, meaning they will die after developing the disease. The cost of care is estimated to be $203 billion in the United States in 2013. In addition, 15.4 million Americans provide unpaid care valued at $216 billion for persons with Alzheimer's and other forms of dementia. Currently, there is no definitive clinical diagnosis for AD other than a postmortem autopsy. Because early diagnosis could enable better planned and coordinated care, there is an urgent need to develop a cost-effective, highly sensitive and selective early stage diagnostic tool for AD. InnoSense LLC (ISL) aims to develop a highly sensitive nanowire-based microelectronic biosensor array (Adnos")-based assay system to provide rapid, reliable, and sensitive early diagnosis of AD by detecting a generally accepted panel of AD-associated protein biomarkers. In Phase I, we aim to demonstrate the performance of an Adnos test system by unambiguously detecting AD protein biomarkers in spinal fluid samples at the nanomolar to picomolar level. ISL will grow nanowires, conjugate antibodies, create a site-specific array, and study assay-related issues, including the following: (1) specific and nonspecific binding, (2) response time, (3) assay volume, (4) sensitivity, accuracy, and measurement precision and (5) signal-to-noise ratio. This Adnos system will have the following widespread socioeconomic benefits: (1) easy-to-use and cost- effective point-of-care tests in doctor's offices, clinics and hospitals, (2) improved and reliable patient care through a multifunctional prognostic/diagnostic test that can be administered by healthcare providers, (3) a valuable research tool for studies of non-AD dementia and neurological diseases and conditions, and (4) a new immunoassay-based research tool for the pharmaceutical/biotechnology industries, government, and academia.