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

The broader impact/commercial potential of this project relates to the management of clotting and bleeding which is a major clinical challenge that costs > $100B healthcare system burden. In the 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 of protein and cellular pathways that react in the context of blood flow. Proven diagnostic tools that capture this complexity, and also meet the constraints of diverse challenges do not exist. This project intends to create a novel modular hemostasis test platform using proprietary microsystem modules deployed in configurable cartridges tailored to meet clinical requirements. Initially a 3D microelectrode based platelet function test module will be developed and optimized with potential 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, low cost platelet function assay (PFA) with the objective of delivering best in class performance via multiscale optimization of the local biophysical diagnostic environment. Multiplate Electrode Aggregometry (MEA), a macroscale impedance-based device has already shown promise, yet remains cumbersome and has suboptimal classification accuracy between patient subsets. In MEA tests, as with most PFAs, the role of local fluid shear and macro/microscale physical environment 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 function testing for the broadest possible benefits.