Development of an Optical Instrument For Label-Free Assays

开发用于无标记测定的光学仪器

• 批准号: 7927247
• 负责人: David Wiliam Ralin
• 金额: $ 196.5万
• 依托单位: MAVEN TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-27 至 2012-09-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7927247
• 关键词: Agreement; Area; Autoimmune Process; Binding; Biological; Biological Assay; Biological Sciences; Blood; Budgets; Cardiovascular Diseases; Clinical; Collaborations; Complex; Computer software; Contractor; Cost of Illness; Detection; Development; Device or Instrument Development; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Disease; Drops; Early Diagnosis; Engineering; Enzyme-Linked Immunosorbent Assay; Feedback; Fostering; Health Care Costs; Human Resources; Immunoassay; Industry; Knowledge; Label; Liquid substance; Malignant Neoplasms; Manufacturer Name; Marketing; Medical; Medicine; Molecular; Names; Occupations; Optical Instrument; Optics; Pharmacologic Substance; Production; Reader; Reagent; Research; Resources; Sales; Saliva; Sampling; Science; Secure; Site; Surface; System; Techniques; Technology; Testing; Workload; Writing; assay development; base; cost; cost effective; design; drug development; experience; high throughput technology; innovation; instrument; minimally invasive; new technology; programs; prototype; public health relevance; validation studies

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.

描述（由申请人提供）：美国的医疗费用正以前所未有的速度增长。至关重要的是，要促进降低疾病诊断和研究总成本的新技术，同时允许早期发现和预测医学。Maven Technologies开发了一种光学分子结合检测技术，称为无标签内反射椭偏法（LFIRE），这是一种成本效益高、灵敏度高、高通量的技术，能够取代更昂贵的ELISA用于单组分免疫分析和Luminex平台用于多组分分析市场。LFIRE减少了执行和开发检测的工作量、一次性试剂的成本和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，能够早期诊断复杂疾病，如癌症、自身免疫性疾病、传染病和心血管疾病等。该提案描述了四个具体目标。首先，将创建两个“alpha”原型单位。其次，将在用户站点安装五个测试版装置，以便与诊断试剂盒制造商进行反馈和测试。第三，将与我们的诊断合作伙伴共同开发检测方法，包括将ELISA试剂盒转移到LFIRE平台的验证研究。最终目标是在2012年5月发射极化子。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的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。