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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力解决了美国医疗保健系统面临的挑战，这些挑战是由神经系统疾病和创伤造成的，仅在美国就影响了1亿多患者，相关成本超过1.3万亿美元，这是由于缺乏在疾病影响神经组织无法修复之前检测疾病发作的诊断工具造成的。神经系统生物标志物是应对这一挑战的一种有前景的新方法，占530亿美元全球生物标志物市场的10%，并以14.5%的复合年增长率增长。该一期项目旨在为研究和患者护理提供基于神经系统生物标志物的低成本血液检测产品，提供新的诊断信息。预计可以及早发现脑震荡、痴呆、脑瘤或神经系统疾病引起的基线变化，从而及时进行干预。这个小企业创新研究（SBIR）一期项目是基于发现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。这些细胞被招募到受伤或患病的大脑，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志物，但它们非常稀释且难以检测，但该项目旨在利用这一发现，即满载碎片的细胞可以重新进入血液。拟议的项目将开发技术和仪器，从少量血液（例如手指刺破）中捕获和量化这些吞噬细胞，以确定所涉及的特定细胞类型，并测定其脑特异性生物标志物含量。由于正常的蛋白质周转也会影响大脑，因此将对来自认知正常供者的血液样本进行测试，以建立这些携带生物标志物的吞噬细胞及其货物的基线浓度。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识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.