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

这个小企业创新研究（SBIR）一期项目填补了生物和化学传感器发展的关键技术空白。对于能够容易地检测分子、细胞或临床反应，从而指示疾病发病或预测哪些候选药物将具有有害副作用的检测方法的需求尚未得到满足。在这个项目中，我们正在通过创新和商业化一种可靠、敏感和准确的测试来满足这一需求，该测试可以同时监测和量化生物液体（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的发病、疾病进展或药物疗效。该测试很简单，可以使用现有的实验室设备进行，可以很容易地被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，假阳性信号通常是由非靶蛋白检测试剂之间的非特异性结合引起的。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。初步测试的蛋白质组将用于心血管疾病管理和药物开发。这个项目的更广泛的影响/商业应用是在10亿美元的生命科学研究市场，目前主要是由一次只能检测一种蛋白质的测试服务。一个一个地测量蛋白质是费时费力的。该研究具有巨大的潜力，可作为高精度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。这种创新的新检测方法在366亿美元的合同研究机构市场上也有潜在的应用，可以改善药物的安全性和有效性测试，降低临床试验成本，缩短上市时间。这一提议推动了生物和化学技术（BC）以及纳米技术、先进材料和制造（NM）领域的发展。

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)