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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力解决了仅在美国就影响1亿多患者的神经系统疾病和创伤给美国医疗体系带来的挑战，以及相关成本超过1.3万亿美元，原因是缺乏诊断工具在疾病发生之前检测疾病的发作，使其无法修复。神经学生物标记物代表了应对这一挑战的一种有前途的新方法，占全球530亿美元生物标记物市场的10%，并以14.5%的复合年增长率增长。这个第一阶段的项目旨在为研究和患者护理提供基于神经生物标记物的低成本血液检测产品，提供新的诊断信息。预计脑震荡、痴呆症、脑瘤或神经疾病引起的基线变化可以及早发现，从而允许及时干预。这项小型企业创新研究(SBIR)第一阶段项目的基础是，外周血中的特定免疫细胞(吞噬细胞)可以作为大脑健康的诊断指标。众所周知，这些细胞被招募到受伤或患病的大脑中，以清除炎症反应产生的细胞碎片。虽然目前的方法试图识别血清中的神经生物标记物，这些标记物非常稀薄，很难检测到，但该项目的目标是利用携带碎片的细胞可以重新进入血流的发现。拟议的项目将开发技术和仪器，以从少量血液中捕获和量化这些吞噬细胞(例如手指刺痛)，以确定所涉及的特定细胞类型，并分析其脑部特定生物标记物的含量。由于正常的蛋白质周转也会影响大脑，来自认知正常捐赠者的血液样本将进行测试，以确定这些携带生物标记物的吞噬细胞及其货物的基线浓度。这一裁决反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.