Home-based plasma self-collection device for remote diagnosis and monitoring of AD-associated biomarkers

Project Summary/Abstract Lo Bio has developed the P1™, a microtube that collects whole blood and separates it into lab quality cell-depleted liquid plasma at the point-of-draw. Our innovation uses proprietary magnetic beads designed to capture and separate blood cells from plasma in 1 min with over 99.9% efficiency. The P1 will enable the collection of laboratory-quality, high-yield, and stable plasma in essentially any remote environment and at a low cost. While the P1 can improve access to diagnostics broadly, industry experts suggest to us that helping to diagnose and monitor participants of clinical studies for Alzheimer’s Disease (AD) is one of the most important applications today. In particular, demonstrating its compatibility with the p-Tau 217 biomarker is highly important given that it is one of the most studied biomarkers and is recognized by the scientific and clinical communities as one of the most promising biomarkers for AD diagnosis and monitoring. In this application we propose to advance key elements of the P1 technology, including optimize antibody binding efficiency, demonstrate sample biocompatibility with p-Tau 217 analysis, and conduct pre-clinical validation comparing P1-separated plasma against centrifuged plasma for plasma quality. Aim #1. Develop Custom aRBC Monoclonal Antibody. We will work with Lampire Biologicals to develop a custom mouse monoclonal antibody and demonstrate comparable plasma quality to centrifugation. Aim #2: Conduct equivalence and sample stability study. To validate use for AD clinical trials, we will demonstrate strong correlation (R>0.9) between P1 and centrifuged plasma for p-tau 217 quantitation. We will also conduct a 3-day stability study to demonstrate that ptau217 is stable in P1 plasma for at least 24 hours of simulated shipping (<15% bias). Aim #3: Complete implementation study. We will conduct a 15-person usability and analytical study to validate that self-collected plasma produced by the P1 is suitable for use in decentralized settings. Success is defined as having >90% successful use of P1 by lay-users and >95% equivalency between P1 and centrifuged plasma.