SBIR Phase I: A novel shear-based platelet function test (PFT) using 3D MEMS electrodes

该项目更广泛的影响/商业潜力与血栓和出血的管理有关，这是一项重大的临床挑战，耗资1000亿美元的医疗系统负担。在美国，它影响了1000多万大手术、创伤、心血管疾病、中风和癌症患者。潜在的生物学是蛋白质和细胞通路的复杂编排，这些通路在血液流动的背景下做出反应。不存在能够捕捉到这种复杂性并满足不同挑战限制的成熟诊断工具。该项目旨在创建一个新的模块化止血测试平台，使用专利微系统模块，部署在可配置的墨盒中，以满足临床需求。首先，将开发和优化基于3D微电极的血小板功能测试模块，在对动态、物理诊断环境进行多尺度优化后，具有实现同类最佳性能的潜力。该小型企业创新研究(SBIR)第一阶段项目旨在开发一种简单、低成本的血小板功能分析(PFA)，目标是提供本地生物物理诊断环境的多尺度优化的同类最佳性能。多板电化学聚集仪(MEA)是一种基于阻抗的大尺度设备，已经显示出前景，但仍然很繁琐，患者亚组之间的分类精度不佳。在MEA测试中，就像大多数PFA一样，局部流体剪切和宏观/微观物理环境的作用仍然在很大程度上被忽视，尽管它们在血小板反应中的作用是众所周知的。初步工作表明，控制和修改PFA性能的潜力尚未开发。通过针对临床终点和亚群分化优化这些信号，这种基于剪切的微型血小板功能测试模块将使血小板功能测试发生革命性变化，从而获得最广泛的可能好处。

The broader impact/commercial potential of this project relates to the management of clottingand bleeding which is a major clinical challenge that costs $100B healthcare system burden. Inthe United States, it affects more than ten million patients of major surgery, trauma,cardiovascular disease, stroke and cancers. The underlying biology is a complex orchestration ofprotein and cellular pathways that react in the context of blood flow. Proven diagnostic tools thatcapture this complexity, and also meet the constraints of diverse challenges do not exist. Thisproject intends to create a novel modular hemostasis test platform using proprietary microsystemmodules deployed in configurable cartridges tailored to meet clinical requirements. Initially a3D microelectrode based platelet function test module will be developed and optimized withpotential for best in class performance following multi-scale optimization of the dynamic,physical diagnostic environment.This Small Business Innovation Research (SBIR) Phase I project seeks to develop a simple, lowcost platelet function assay (PFA) with the objective of delivering best in class performance viamultiscale optimization of the local biophysical diagnostic environment. Multiplate ElectrodeAggregometry (MEA), a macroscale impedance-based device has already shown promise, yetremains cumbersome and has suboptimal classification accuracy between patient subsets. InMEA tests, as with most PFAs, the role of local fluid shear and macro/microscale physicalenvironment remains largely neglected despite their well-recognized role in platelet response.Preliminary work suggests untapped potential in controlling and modifying PFA performance.By optimizing these signals with respect to clinical end points and subpopulation differentiation,this shear-based micro-platelet function test modules stand to revolutionize platelet functiontesting for the broadest possible benefits.