THE THE PURPOSE OF THE PHASE II PROGRAM IS TO FOCUS ON DEVELOPING A T-CELL ACTIVATION PROTOCOL CONSISTENT WITH REPORTERCELL VIABILITY, DEVELOPING A PR

Quantifying the HIV latent reservoir is a key component to achieving a cure for HIV. Molecular methods for latent infection remain challenging, and while they potentially identify full-length viral genomes, their ability to functionally evaluate viral replication is limited. Here, we continue the development and commercialization of the Microwell Outgrowth Assay (MOA), using Cell Microsystems' proprietary CellRaft Technology. By coculturing patient-derived T-cells with a reporter cell line capable of detecting HIV virus, millions of cells can be screened on a single microwell cell culture device. Using the microwell array developed by Cell Microsystems, the CytoSort Array, and the automated image analysis platform, the CellRaft AIR System, the MOA assay has been demonstrated as a promising automated means of quantifying the HIV latent reservoir.During Phase II we will extend these studies to an optimized T-cell activation protocol, development of a custom reporter cell line and benchmarking MOA performance in clinical samples against the commonly used Quantitative Viral Outgrowth Assay (QVOA). The commercial potential for the assay is high given the need for latent reservoir diagnostics for HIV therapeutic screening, clinical trials and ultimately, companion diagnostics for patients on therapies intended to cure.