SBIR Phase I: Development of Soluble Analyte Amplification for PBP2a Detection

该小型企业创新研究（SBIR）I期项目旨在开发一种原型可行性检测方法，用于使用创新的专利检测技术低水平检测耐甲氧西林金黄色葡萄球菌（MRSA）蛋白生物标志物青霉素结合蛋白2a（PBP2a）。 该公司开发了一种名为可溶性分析物扩增（SAM）的检测技术，这是一种多功能诊断平台，能够识别溶液中目前无法检测到的生物分子。在美国，每年有超过94，000名患者获得MRSA血流感染，死亡率几乎为20%。目前，没有诊断平台可以直接从血液中检测MRSA。该项目将使用SAM技术开发一种检测血液中PBP2A的检测方法。这项研究的更广泛影响是开发创新的SAM技术，该技术将作为SAM在人类医学中找到多种应用的跳板。虽然临床诊断测试已经深刻地影响了医疗保健的提供，但目前市场上的测试的灵敏度不具有检测在疾病早期观察到的低水平分子的能力，此时治疗更有效。引入基于SAM的测定系统作为用于检测非常低浓度的蛋白质、碳水化合物和其他感兴趣分子的灵敏且易于使用的技术，将增强对许多疾病的理解，并导致治疗和早期检测策略的重要进展。

This Small Business Innovation Research (SBIR) Phase I project is to develop a prototype feasibility assay for low level detection of methacillin resistant Staphlococcus aureus (MRSA) protein biomarker, Penicillin Binding Protein 2a (PBP2a), using an innovative, patented detection technology. The company has developed a detection technology called Soluble Analyte Amplification, or SAM, a versatile diagnostic platform that is capable of identifying biological molecules at currently undetectable concentrations in solution. In the US over 94,000 patients acquire MRSA bloodstream infection yearly with a mortality rate of almost 20%. Currently, no diagnostic platforms can detect MRSA directly from blood. The project will use the SAM technology to develop an assay that will detect PBP2A in blood.The broader impacts of this research are the development of the innovative SAM technology that will serve as a springboard from which SAM will find multiple applications in human medicine. While clinical diagnostic testing has profoundly impacted healthcare delivery, the sensitivity of tests currently on the market do not have the ability to detect molecules at the low levels observed early in disease when treatment is more efficacious. Introduction of a SAM-based assay system as a sensitive and easy to use technology for detection of proteins, carbohydrates and other molecules of interest at very low concentration will enhance the understanding of many diseases and lead to important advances in therapeutics and early detection strategies.