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

SBIR II 期：开发用于心血管疾病研究的强大多重蛋白质测试

• 批准号: 1456281
• 负责人: John Dishinger
• 金额: $ 75万
• 依托单位: PhasiQ, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1456281&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; robust

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.

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，主要是通过多重蛋白质测试服务。 这里提出的研究具有巨大的潜力，可以作为高度准确和强大的检测与心血管疾病相关的蛋白质的工具。 此外，这项核心技术的发展可用于许多其他疾病的研究。 该项目开发的产品在制药和合同研究组织市场中具有潜在的应用，用于药物发现，监测治疗效果和协助临床研究。 虽然该第二阶段提案包括DVT面板的开发和商业化，但商业产品供应将涵盖用于研究应用的更广泛的疾病相关蛋白质（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）。拟议的项目将产生更好，更强大的检测患者血液中疾病相关蛋白质的工具。 该产品将能够同时测量多种蛋白质的量，而不会出现所谓的问题。抗体串扰？这在使用其他技术时妨碍了结果的质量。 该项目的工作将涉及开发一个套件，其中包括设备和试剂，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，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），直到用于临床样本的分析。 患者样本，已经收集，银行，并在IRB批准下去识别，将与密歇根大学的研究人员合作进行分析。II期支持的结果将包括一个有用的多重蛋白质生物标志物免疫测定平台，该平台已使用患者血液样本进行了验证。