SBIR Phase II: Development of a robust multiplex protein test for cardiovascular disease research

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是在10亿美元的生命科学研究市场，该市场主要由复合蛋白质测试提供服务。这里提出的这项研究具有巨大的潜力，可以作为一种工具，高度准确和可靠地检测与心血管疾病有关的蛋白质。此外，这项核心技术的开发还可以用于许多其他疾病的研究。在该项目期间开发的产品在制药和合同研究组织市场具有潜在的应用，用于药物发现、监测疗效和辅助临床研究。虽然这项第二阶段的提案包括DVT面板的开发和商业化，但商业产品将涵盖更广泛的用于研究应用的疾病相关蛋白质(例如学术研究人员、合同研究组织或制药公司感兴趣的蛋白质组合)。拟议的项目将产生一个更好、更强大的工具来检测患者血液中的疾病相关蛋白质。该产品将能够一次测量多种蛋白质的数量，而不会出现被称为抗体串扰的问题，而在使用其他技术时，抗体串扰会阻碍结果的质量。该项目的工作将包括开发一种包括设备和试剂的试剂盒，供最终用户使用和分析血液样本中的感兴趣蛋白质，在这种情况下，这些蛋白质与心血管疾病有关。作为第一阶段资金的一部分，已经开发了一个工作原型设备，第二阶段将改进该设备(增加分析时间和多路复用)，直到可用于临床样本的分析。根据IRB的批准，已经收集、储存和取消身份识别的患者样本将与密歇根大学的研究人员合作进行分析。第二阶段支持的结果将包括一个有用的多路复用蛋白质生物标记物免疫分析平台，该平台已经使用患者血液样本进行了验证。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in the $1 billion life science research market that is served mainly by multiplex protein tests. The research proposed here has tremendous potential as a tool for highly accurate and robust detection of proteins that have been linked to cardiovascular disease. Additionally, the development of this core technology can be used for research of numerous other diseases. The product developed during this project has potential applications in the pharmaceutical and contract research organization markets for drug discovery, monitoring therapeutic efficacy, and assisting with clinical studies. While this Phase II proposal includes the development and commercialization of a DVT panel, the commercial product offering will cover a wider variety of disease-related proteins for research applications (e.g. protein combinations in which academic researchers, contract research organizations, or pharmaceutical companies have interest).The proposed project will result in a better, more robust tool for detection of disease-related proteins in patient blood. The product will be able to measure the amounts of multiple proteins at one time without a problem known as ?antibody crosstalk?, which hinders the quality of results when using other technologies. Work on this project will involve developing a kit that includes equipment and reagents for an end-user to work with and analyze blood samples for proteins of interest, in this case those involved with cardiovascular disease. A working prototype device was developed as part of Phase I funding, and Phase II will improve upon the device (increased analysis time and multiplexing) until useful for the analysis of clinical samples. Patient samples, already collected, banked, and de-identified under IRB approval, will be analyzed in a collaborative effort with researchers at the University of Michigan. Results from Phase II support will include a useful multiplexed protein biomarker immunoassay platform that has been validated using patient blood samples.