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

Lo Biosciences, Inc. received a $305,621 Project Grant from the National Institute on Aging under the Aging Research program (CFDA 93.866) awarded on September 25, 2025, with completion targeted for September 24, 2026. The company is advancing its P1 microtube technology—a point-of-care device that collects whole blood and separates it into laboratory-quality, cell-depleted plasma within one minute using proprietary magnetic beads with over 99.9% efficiency. This innovation enables remote collection of plasma suitable for diagnostic testing in various environments at low cost, addressing critical needs for accessible biomarker analysis in clinical studies.

The funded project focuses specifically on validating the P1 device's compatibility with phosphorylated tau 217 (p-tau 217) biomarker analysis for Alzheimer's Disease diagnosis and monitoring. Deliverables include development of a custom monoclonal antibody for red blood cell capture (in collaboration with Lampire Biologicals), demonstration of strong correlation (R>0.9) between P1-separated plasma and centrifuge-separated plasma for p-tau 217 quantitation, and a three-day stability study confirming p-tau 217 stability during shipping. The project establishes performance benchmarks of 90% successful use by lay-users and greater than 95% equivalency between the P1 device and centrifugation-based plasma collection methods.

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 (90% successful use of P1 by lay-users and >95% equivalency between P1 and centrifuged plasma.