A novel remote blood separation device for at-home plasma collection for HIV-1 testing

PROJECT SUMMARY There are 1.1 million persons living with HIV (PLWH) in the US with an estimated 13% who are unaware of their infection. Antiretroviral therapy (ART) has been a successful approach to improving health outcomes for patients and reducing transmission through maintenance of viral suppression. Current guidelines recommend PCR- based viral load (VL) testing 2-8 weeks after initiation of ART and every 3-6 months thereafter to routinely confirm medication adherence and maintenance of viral suppression. Without regular VL testing, it is not possible to know a patient’s current state. However, there are currently no at-home based approaches for measuring VL, which means that PLWH must regularly travel to clinical laboratory sites for a blood draw and testing. There is a need for novel at-home collection and testing options for PLWH to 1) increase compliance with regular testing to maintain viral suppression and 2) accommodate patients in low- to moderate-resource areas without easy access to testing. Lo Biosciences seeks to transform remote specimen collection for PLWH by advancing development of the P1 device, the first reliable collection approach for generating laboratory-grade plasma at home. This approach is expected to enable patients to easily separate plasma at home and ship the specimen to reference laboratories for analysis with gold standard PCR assays. The P1 uses magnetic bead-based separation, in which functionalized beads capture red blood cells (RBCs) via antibody binding inside a custom tube. The tube is then placed on top of a magnet, and the bound cells are pulled to the bottom in minutes. The supernatant plasma is then squeezed into a standard blood collection tube for storage, shipping, and analysis. Prior to Phase I, LoBio demonstrated effective removal of RBCs using the P1 device. However, for HIV VL testing, white blood cells (WBCs) can introduce false positives due to proviral DNA/RNA. During Phase I, LoBio advanced the P1 device to also significantly deplete WBCs and showed that the resulting plasma could accurately measure HIV VL after 1-2 days of simulated shipping conditions, demonstrating feasibility for at-home collection. The goal of this Phase II project will be to complete development and manufacturing transfer, complete analytical validation of the P1 device for HIV VL testing, and complete method comparison and usability studies that are required for FDA 510(k) clearance of the device. At completion of this project, LoBio will seek FDA clearance. Commercialization of the P1 device is expected to increase accessibility to laboratory testing toward increasing adherence to HIV VL testing and enabling more patients to monitor their VL.