NeuroVision is the recipient of two research awards from the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator initiative.  The Diagnostics Accelerator was founded by Bill Gates and Leonard A. Lauder, bringing philanthropic capital with a venture mindset to advance new ideas for the development of reliable and affordable biomarker tests for Alzheimer’s Disease.

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.

Principal Investigator: Leyla Anderson, MD, PhD, D(ABMLI)

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.

Validation of blood-based biomarkers for the detection of brain amyloid accumulation before clinical onset of dementia.

Principal Investigator: Leyla Anderson, MD, PhD, D(ABMLI)

Despite the prevalence of Alzheimer's disease, the lack of an early and accurate diagnostic test remains a significant hindrance to the discovery of therapeutics. Our goal is to develop a screening tool for the early detection of Alzheimer's disease before symptoms are obvious. We have discovered proteins and metabolites in the blood that have the potential to provide an early diagnosis of Alzheimer's disease. We aim to validate the diagnostic accuracy of these biomarkers as the first steps toward more wide spread use.  We will determine the diagnostic accuracy of the biomarkers with samples from the Australian Imaging and Biomarker Lifestyle study of ageing (AIBL), which is one of the largest studies of Alzheimer's disease in the world. Overall, the information gained will be a significant step forward in the development of the first approved blood test of Alzheimer’s disease.