DETECTION OF ALZHEIMER'S DISEASE USING A POLYMER NANOWIRE-BASED BIOSENSOR

描述（由申请人提供）：InnoSense LLC（ISL）提交了此修订后的申请，旨在开发一种具有成本效益和高灵敏度的基于聚合物凝胶的电子生物传感器（PNEBD），用于早期筛查阿尔茨海默病（AD）。预计该器械在早期治疗和可能延迟与该疾病相关的衰弱症状方面具有潜在的重要意义。第一阶段项目的重点是基于硅光刻工艺和窄间隙电极结之间的功能化导电聚合物的无模板电沉积的高通量装置的开发和验证。已经提出了六项任务来建立检测淀粉样蛋白衍生的扩散配体（ADDL）抗原（AD的生物标志物）的I期可行性，使用淀粉样蛋白（A）寡聚体特异性抗体检测ADDL。目前的证据有力地表明淀粉样蛋白（A）在AD的发病机制中起着重要作用。目前，除了尸检之外，AD还没有明确的临床诊断。已经证明，ADDL以显著升高的水平存在于患有AD的人类的尸检脑样品中。ADDL与AD的这种关联表明PNEBD设备可以为AD的实验室诊断提供确定的分子基础。为了确保成功，已组建了一个高技能的研究小组，包括一名反倾销专家，以执行该项目。发展超灵敏的阿尔茨海默病（Alzheimer's disease，AD）早期筛查方法是AD临床诊断和发病机制研究的重要课题。AD是一种进行性神经退行性疾病，既没有治愈方法，也没有早期诊断设备。它是65岁以上老年痴呆症的主要原因，影响了400多万美国人。尽管其极其重要，但尚未开发出用于临床实验室诊断AD的超灵敏技术。InnoSense LLC旨在通过开发一种具有成本效益和高灵敏度的基于聚合物纳米晶的电子生物传感器设备（PNEBD）来填补这一空白。该设备将利用电化学生长的聚合物纳米线在微米到纳米级图案化的电极结检测淀粉样蛋白衍生的扩散配体（ADDL）。ADDL已被确定为AD的生物标志物。使用电化学方法的目的是在电极结上生长无模板、低成本和高质量的聚合物纳米线。这种直接的一步制造技术是可扩展的。该项目将推进我们对阿尔茨海默病检测的知识。

DESCRIPTION (provided by applicant): InnoSense LLC (ISL) submits this revised application with the intent of developing a cost-effective and highly sensitive polymer nanowire-based electronic biosensor (PNEBD) for the early screening of Alzheimer's disease (AD). This device is expected to have potentially significant implications in the early treatment and possible delay of debilitating symptoms associated with this disease. The Phase I project is focused on the development and verification of a high-throughput device based on silicon photolithography processes and template-free electrodeposition of functionalized conductive polymers between narrow-gap electrode junctions. Six tasks have been proposed to establish the Phase I feasibility of detecting amyloid-¿ derived diffusible ligand (ADDL) antigen, a biomarker for AD, using amyloid-¿ (A¿) oligomer specific antibody to ADDLs. Current evidence strongly suggests a central role for amyloid-¿ (A¿) in the pathogenesis of AD. At the present time there is no definite clinical diagnosis for AD other than autopsy. It has been demonstrated that ADDLs are present at significantly elevated levels in the autopsied brain samples of humans with AD. This association of ADDLs with AD suggests that the PNEBD device could provide a definitive molecular basis for the laboratory diagnosis of AD. For ensuring success, a highly skilled research team, including an expert on AD, has been assembled to execute the project. Development of ultrasensitive detection methods for early screening of Alzheimer's disease (AD) is an important issue in clinical disease diagnosis and mechanistic understanding of Alzheimer's disease (AD). AD is a progressive neurodegenerative disease for which there is neither a cure nor an early diagnostic device. It is the leading cause of dementia in people over age 65 affecting over four million Americans. Despite its utmost importance, no ultrasensitive technologies have been developed for clinical lab diagnostic of AD. InnoSense LLC aims to fill this void by developing a cost-effective and highly-sensitive polymer nanowire-based electronic biosensor device (PNEBD). This device will utilize electrochemically grown polymer nanowires at micro- to nanoscale patterned electrode junctions for detecting amyloid-¿ derived diffusible ligands (ADDLs). ADDL has been established as a biomarker for AD. The purpose of using an electrochemical method is to grow template-free, low-cost and high quality polymer nanowires on to the electrode junctions. This direct, one-step fabrication technique is scalable. This project will advance our knowledge on the detection of Alzheimer's disease.