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NeuroVision Imaging, Inc.

Leyla Anderson, MD, PhD, D(ABMLI) | California, United States

NeuroVision Imaging, Inc.

Leyla Anderson, MD, PhD, D(ABMLI) | California, United States

Validation and commercialization of a novel blood-based, ultra-multiplex Laboratory Developed Test (LDT) for the prediction of cerebral amyloid status before clinical onset of dementia.

This proposal is for an accelerated path to commercialize an ultra-multiplex assay to measure multiple blood biomarkers including various Tau and phospho-Tau isoforms, GFAP, NfL, and amyloid beta peptides in addition to a proprietary assay in blood for the prediction of brain amyloid. The goal is to optimize and validate our prototype assays for commercialization as an LDT and eventual IVD. Availability of such an ultra-multiplex blood assay consisting of a hybrid approach (multiplex assay together with a novel, proprietary assay) will provide a vital clinical tool. Following optimization of our current assays, we will validate the diagnostic accuracy of each assay (stand-alone, as well as combined) to detect brain amyloid in cognitively normal, MCI and AD subjects. Currently, only few ultra-sensitive technologies exist that can detect the exceptionally low concentrations of Alzheimer’s Disease (AD) core biomarkers in blood. Nevertheless, these platforms are not readily scalable to meet commercial demands and they are difficult to customize for multiplex assays. NeuroVision has exclusive rights to a robust, ultra-sensitive, chip-based platform by MagArray in the field of Neurology. Building on magnetic read head technology from the hard drive industry, MagArray has designed a proprietary nanosensor that is highly responsive to local magnetic fields. By combining traditional immunoassay principles with integrated circuit design and nanofabrication, this novel technology brings a combination of ultra-sensitivity, multiplexing capacity, and ease of use to immunoassays. The result is an exceptionally robust tool for laboratory diagnostics. Once labeled with magnetic nanoparticles, disease biomarkers can be immediately detected in real time without a need for complex optics or fluidics. Furthermore, this platform has been successfully implemented in a CLIA certified laboratory for clinical sample testing.