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

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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.