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.

Public Health Relevance

Alzheimer's disease (AD) is a debilitating and progressively neurodegenerative disease that has no known cure. It is the leading cause of dementia among Americans over age 65, yet it lacks early diagnostic means. Despite the utmost importance of early diagnosis, no ultrasensitive clinical lab diagnostic technologies have been developed for AD. This project focuses on developing a cost-effective and highly-sensitive assay for screening, diagnosing, and clarifying the mechanisms of AD pathogenesis by utilizing a polymer nanowire microelectronic biosensor array (Adnos) device. InnoSense LLC (ISL), in collaboration with the University of California, Irvine, will validate Adnos performance on samples containing well-established and accepted AD biomarkers at less than 1 nanomolar levels. This project will advance our knowledge on the detection of Alzheimer's disease. In Phases II/III, ISL will collaborate with Conductive Technologies Inc. (CTI;York, PA) for mass production of patterned microelectrode biosensor devices. For marketing and commercialization of Adnos technology, ISL will collaborate with EMD Millipore (Billerica, MA), a leading provider of Life Science tools. EMD Millipore also market and sell cutting-edge life science products and services. Both CTI and EMD Millipore letters of interest are attached with this proposal.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Hsiao, John
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Innosense, LLC
United States
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