Democratizing Early Detection and Longitudinal Monitoring of Alzheimer's Disease: An Ultra-Sensitive Blood-Based Assay

/ABSTRACT Redwood Neuro aims to revolutionize Alzheimer’s Disease (AD) diagnostics through the development of the SiMoLiSA platform, a pioneering technology designed to deliver a detection capability previously only achievable through high- end single molecule counting technologies. This innovative platform offers an open, more accessible immunoassay approach akin to ELISA yet one that surpasses the performance of the most advanced single molecule counting technologies in terms of sensitivity and specificity at a fraction of the cost. Unlike conventional systems that often require expensive, proprietary equipment, SiMoLiSA utilizes affordable, widely available consumables and simple equipment. This makes it easier to implement and scale in a variety of laboratory settings, from academic research facilities to clinical diagnostic centers. By breaking down the cost and complexity barriers associated with advanced diagnostic technologies, SiMoLiSA enables broader access to cutting-edge detection capabilities, making it a game- changer for disease diagnostics and biomarker research. By employing our proprietary Single-Molecule Linked Surrogate Assay, SiMoLiSA will enhance the detection of critical AD biomarkers, such as p-tau proteins and β-amyloid, with unprecedented sensitivity and affordability. Unlike current high-cost ultrasensitive systems, SiMoLiSA is an open platform that uses cost-effective materials and innovative techniques to detect biomarkers at femtogram/milliter (fg/ml) levels—capabilities traditionally reserved for the most advanced and expensive platforms such as single molecule counting assay. This project will execute two primary phases: firstly, establishing a comprehensive 7-biomarker panel (p-tau-181, p-tau-217, p-tau-231, total-tau, Aβ42, Aβ40, and NfL) for AD and validating it against state-of-art immunoassay platform using contrive human serum samples and demonstrate an ability to detect AD biomarkers at femtogram/milliter (fg/ml) levels and over 6-log dynamic range in a highly reproducible manner (R2 > 0.98); secondly, rigorously testing this technology with CSF and plasma clinical samples to confirm its performance and reliability in real-world settings in a CLIA-certified lab. By making early and accurate AD diagnosis more accessible, SiMoLiSA not only promises to enhance clinical outcomes for patients by enabling earlier intervention but also aims to reduce overall healthcare costs associated with the management of Alzheimer’s Disease. This aligns directly with public health goals by addressing the growing need for effective diagnostic tools in the aging population. Project Number: 1R43AG097403-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Murat Baday (+1 co-PI) | Institution: REDWOOD NEURO INC., IRVINE, CA | Award Amount: $506,061 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZAG1 ZIJ-T (M3)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11262148