AD-MS Chips for Biofluids-Based Diagnosis of Alzheimer's Disease

项目总结/摘要 阿尔茨海默病（AD）是一种破坏性的神经退行性疾病，影响超过3500万人 （包括500万美国人），预计到2015年，这一数字将超过1.15亿。 2050年。最近来自大量AD治疗临床试验的令人失望的结果进一步加剧了 问题所在一个主要的挑战是目前没有基于血液的生物标志物用于早期诊断或靶点 AD的治疗该领域需要变革性的技术和方法。根据PAS-17-064， Newomics Inc.提出SBIR第二阶段项目，以完成其产品AD-MS芯片的开发， 通过这些微流控芯片实现的多组学分析，用于基于生物流体的AD诊断。二期工程 是建立在我们的第一阶段项目产生的有希望的结果。在第一阶段，我们开发了 集成硅微流控芯片作为基于LC-MS的多组学的高通量和多重平台 测定。我们已经使用我们独特的平台对临床样本进行了初步的多组学实验。 此外，我们已经实施了统计和生物信息学方法来发现新的生物标志物面板 以及AD早期诊断的途径和网络。在第二阶段，我们将优化和验证我们的平台， 多组学分析具有回顾性和前瞻性临床样品的大队列。一旦开发出来， Newomics的集成平台和解决方案将实现快速、低成本、可重复、高度特异性和 敏感的多重测量人外周血和CSF样本，并有助于早期 AD的诊断和靶向治疗。

Project Summary/Abstract Alzheimer's disease (AD) is a devastating neurodegenerative disease that affects more than 35 million people (including 5 million Americans) worldwide, and this number is expected to reach more than 115 million by the year 2050. Recent disappointing results from a large number of clinical trials for AD treatment further aggravate the problem. One major challenge is there is currently no blood-based biomarker for early diagnosis or target therapy of AD. The field is calling for transformative technologies and approaches. In response to PAS-17-064, Newomics Inc. proposes this SBIR Phase II project to complete development of its product, AD-MS chips and multiomics assays enabled by these microfluidic chips, for biofluids-based diagnosis of AD. The Phase II project is built upon the promising results generated from our Phase I project. In Phase I, we have developed the integrated silicon microfluidic chips as a high-throughput and multiplex platform for LC-MS-based multiomics assays. We have performed preliminary multiomics experiments on clinical samples using our unique platform. Furthermore, we have implemented statistical and bioinformatics methods to discover new biomarker panels and pathways and networks for early diagnosis of AD. In Phase II, we will optimize and validate our platform and multiomics assays with large cohorts of both retrospective and prospective clinical samples. Once developed, Newomics' integrated platforms and solutions will enable rapid, low-cost, reproducible, highly specific and sensitive multiplex measurements of human peripheral blood and CSF samples, and contribute to early diagnosis and target therapy of AD.