SBIR Phase I: Crosstalk-Free Multiplexed Immunoassay of Plasma Biomarkers

这个小型企业创新研究（SBIR）第一阶段项目填补了生物和化学传感器开发的关键技术空白。 对于容易检测指示疾病发作或预测哪些候选药物将具有有害副作用的分子、细胞或临床反应的测试存在未满足的需求。在这个项目中，我们通过创新和商业化一种可靠、灵敏和准确的测试来满足这一需求，该测试可以同时监测和定量生物液体（血浆、尿液、血清）中多种蛋白质的水平。这些靶蛋白生物标志物指示疾病发作、疾病进展或药物功效。该测试很简单，可以使用现有的实验室设备进行，便于学术实验室和制药公司采用。此外，该测试是唯一可靠地防止假阳性信号的测试，假阳性信号通常由非靶蛋白检测试剂之间的非特异性结合引起。防止假阳性信号至关重要，因为它可以更准确地测量生物液体中的蛋白质。 最初的蛋白质测试小组将用于心血管疾病管理和药物开发。该项目更广泛的影响/商业应用是在价值10亿美元的生命科学研究市场，今天主要是通过一次只能检测单一蛋白质的测试服务。逐个测量蛋白质是时间和劳动密集型的。这项研究具有巨大的潜力，可作为高度准确检测和分析蛋白质生物标志物的研究工具，从而更好地了解疾病的发病机制和治疗反应。这项创新的新测试在价值366亿美元的合同研究组织市场中也有潜在的应用，可以改善药物安全性和有效性测试，降低临床试验成本，缩短上市时间。该提案推进了生物和化学技术（BC）以及纳米技术，先进材料和制造（NM）领域

This Small Business Innovation Research (SBIR) Phase I project fills a key technological gap in development of biological and chemical sensor development. There is an unmet need for tests that easily detect molecular, cellular, or clinical responses that indicate disease onset or predict which candidate drugs will have harmful side effects. In this project, we are addressing this need by innovating and commercializing a reliable, sensitive, and accurate test that simultaneously monitors and quantifies levels of multiple proteins in biological fluids (plasma, urine, serum). These target protein biomarkers indicate disease onset, disease progression, or drug efficacy. The test is simple and can be performed using existing laboratory equipment, allowing for easy adoption in academic labs and pharmaceutical companies. Furthermore, this test is the only test that reliably prevents false positive signals, which typically result from nonspecific binding between non-target protein-detection agents. Preventing false positive signals is crucial because it enables more accurate measure of proteins in biological fluids. An initial test panel of proteins to be tested will be for cardiovascular disease management and drug development.The broader impact/commercial application of this project is in the $1 billion life science research market that today is served mainly by tests that can only detect a single protein at a time. Measuring proteins one by one is time- and labor-intensive. The proposed research has tremendous potential as a research tool for highly accurate detection and analyses of protein biomarkers, leading to better understanding of disease pathogenesis and therapeutic response. The innovative, new test also has potential applications in the $36.6 billion contract research organization market to improve drug safety and efficacy testing, decrease clinical trial costs, and decrease time to market. This proposal advances the fields of Biological and Chemical Technologies (BC) as well as of Nanotechnology, Advanced Materials, and Manufacturing (NM)