SBIR Phase I: Phagocytic Cells in Peripheral Blood as a Novel Diagnostic Tool for Brain Health

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the challenges posed to the US healthcare system resulting from neurologic disease and trauma impacting 100+ million patients in the US alone and associated costs in excess of $1.3 trillion, driven by a lack of diagnostic tools detecting the onset of disease before it affects neuronal tissue beyond repair. Neurologic biomarkers represent a promising new approach to this challenge, comprising 10% of the $53 billion global biomarker market and growing at a 14.5% compound annual growth rate. This Phase I project aims to provide neurologic biomarker-based low-cost blood testing products for research and patient care, providing novel diagnostic information. It is anticipated that changes from baselines resulting from concussions, onset of dementia, brain tumors or neurologic disease, can be detected early, thereby allowing for timely intervention. This Small Business Innovation Research (SBIR) Phase I project is based on the finding that specific immune cells (phagocytes) in the peripheral blood can serve as diagnostic indicators of brain health. It is well established that these cells are recruited to the injured or diseased brain in order to clear the cellular debris resulting from the inflammatory response. While current methods seek to identify neurologic biomarkers in blood serum, where they are very dilute and difficult to detect, this project aims to make use of the finding that debris-loaded cells can reenter the blood stream. The proposed project will develop technologies and instrumentation to capture and quantify these phagocytes from small amounts of blood (e.g. finger prick), to identify the specific cell types involved, and assay their brain-specific biomarker content. Since the normal protein turnover affects the brain as well, blood samples from cognitively normal donors will be tested to establish a baseline concentration of these biomarker-carrying phagocytes and their cargo. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.