Development of an Optical Instrument For Label-Free Assays

描述(由申请者提供)：美国的医疗费用正以前所未有的速度上涨。至关重要的是要促进新技术的发展，以降低疾病诊断和研究的总成本，同时允许更早的检测和预测性医学。Maven Technologies开发了一种名为无标签内反射椭圆术(LFIRE)的光学分子结合检测技术，这是一种经济高效、灵敏和高通量的技术，能够取代用于单链免疫分析的更昂贵的ELISA法和用于多路分析市场的Luminex平台。LFIRE减少了执行和开发分析的工作量，减少了一次性用品的成本，减少了所需生物试剂的数量。该团队将利用这些知识开发一种基于LFIRE的商业仪器，名为Polaron，能够对癌症、自身免疫、传染病和心血管疾病等复杂疾病进行早期诊断。该提案描述了四个具体目标。首先，将创建两个‘阿尔法’原型单元。其次，将在用户现场安装五个测试版单元，以供诊断试剂盒制造商进行反馈和测试。第三个将是与我们的诊断合作伙伴共同开发化验，包括将酶联免疫吸附试验试剂盒转移到LFIRE平台的验证研究。最终目标是在2012年5月之前发射极化子。该项目将受益于与几个分包商和开发伙伴的合作，这些分包商和开发伙伴在生命科学、制药和临床诊断行业的仪器、光学系统和一次性产品开发方面拥有丰富的资源和经验。在项目过程中，将在软件编程、光学工程、表面科学和分析开发方面创造几个高技能的工作岗位。 与公共卫生相关：该项目将向市场推出一种光学仪器，能够在几分钟内诊断复杂的疾病，使用只需一滴血、唾液或其他体液的微创策略。同样的仪器将被用作创新医疗诊断测试的开发平台，这种测试比该领域的任何技术都更具成本效益，而且内在地更准确地用于早期疾病检测。该仪器将具有足够的通用性，以针对三个领域的应用：临床诊断、药物开发和生命科学研究，同时每分钟还提供比同类仪器更多的样本信息。

DESCRIPTION (provided by applicant): Healthcare costs in the US are rising at unprecedented rates. It is vital to foster new technologies that reduce the overall costs of disease diagnostics and research while simultaneously allowing for earlier detection and predictive medicine. Maven Technologies has developed an optical molecular-binding detection technique called Label-Free Internal Reflection Ellipsometry (LFIRE), a cost-effective, sensitive and high-throughput technology capable of displacing the more expensive ELISA for single- plex immunoassays and the Luminex platform for the multiplexed assay market. LFIRE reduces the workload for performing and developing assays, the costs of disposables, and the volumes of biological reagents needed. The team will use this knowledge to develop a commercial instrument based on LFIRE, named Polaron, capable of early diagnosis of complex diseases such as cancer, autoimmune, infectious and cardiovascular diseases, amongst others. The proposal describes four specific aims. First of all, two 'alpha' prototype units will be created. Second, five beta units will be installed at user sites for feedback and testing with a diagnostic kit manufacturers. Third will be assay co-development with our diagnostic partners, consisting of a validation study for the transfer of an ELISA kit to the LFIRE platform. The final aim is the launch of Polaron by May 2012. The project will benefit from collaboration with several sub-contractors and development partners with substantial resources and experience in the development of instruments, optical systems and disposable products in the life science, pharmaceutical and clinical diagnostic industries. During the course of the project, several highly skilled jobs will be created in software programming, optical engineering, surface science and assay development. PUBLIC HEALTH RELEVANCE: This project will bring to market an optical instrument capable of diagnosing complex diseases in minutes using minimally invasive strategies requiring just a drop of blood, saliva, or other bodily fluids. The same instrument will be used as a development platform for innovative medical diagnostic tests, which are more cost effective than any technology in the field and inherently more accurate for early disease detection. The instrument will be universal enough to target applications in three areas; clinical diagnostics, drug development, and life science research while also providing more sample information per minute than any instrument in its class.