Development of a Miniature Mass Spectromtry System for Point-of-Care Applications

 描述（申请人提供）：质谱法（MS）是化学分析的“金标准”，由于其高灵敏度、高特异性以及 定量精度高。传统的质谱化学分析需要复杂的程序，包括样品制备、色谱分离、质谱分析和数据分析的多个步骤。通常需要的设备很大，拥有成本（约40万美元）和维护成本很高。整个过程是劳动密集型的，需要分析化学和质谱实验室技术的专业知识。在这个拟议的项目中，PURSPEC技术公司，与普渡大学合作，将开发一种新的质谱产品，将改变MS分析的即时护理（POC）应用。PURSPEC Technologies，Inc.一家位于印第安纳州的小企业，已经成立，以开发基于普渡大学研究开发的微型MS产品，该研究开发由NIH项目1 R 01 GM 106016和1 R21 RR 031246赞助。普渡大学已经开发了一系列技术和研究原型，用于环境电离和微型质谱仪。拟议的产品将解决现有MS产品在实验室和现场应用中的缺点，并将满足药物发现和临床分析商业市场中未满足的需求。由于现有知识的深度和所涉团队的专业知识，以及成功的初步和可行性研究，PURSPEC正在寻求直接进入第二阶段的奖励。本STTR Direct to Phase II的目标是开发一个完整的POC-MS系统，作为产品原型及其相关的操作方案，用于当地临床研究中心的化学分析，并最终用于个人医疗保健。目的 一曰：目标2：设计采样盒并优化样品处理方案;目标3：开发支持POC-MS系统的软件和数据库;目标4：验证集成的POC-MS系统和分析方案。第二阶段工作的预期成果是交付第一个POC-MS系统的产品原型，该系统具有相对完整的临床分析解决方案。在第二阶段成功之后，PURSPEC将准备将负担得起的，易于使用的和独立的便携式设备商业化。这种装置有相当大的市场。

 DESCRIPTION (provided by applicant): Mass spectrometry (MS) is the "gold standard" for chemical analysis and has been widely applied due to its high sensitivity, high specificity as well as high quantitation precision. Traditional chemical analysis using MS requires complex procedures, including multiple steps for sample preparation, chromatographic separation, MS analysis and data analysis. Equipment typically required is large and of high cost for ownership (~$400K) and maintenance. The entire procedure is labor intense and requires expertise in laboratory techniques for analytical chemistry and mass spectrometry. In this proposed project, PURSPEC Technologies Inc., in collaboration with Purdue University, will develop a new mass spectrometry product that will transform the MS analysis for point-of-care (POC) applications. PURSPEC Technologies, Inc., an Indiana-based small business, has been founded to develop miniature MS products based on the research development at Purdue University, which has been sponsored by NIH projects 1R01GM106016 and 1R21RR031246. A series of technologies and research prototypes have been developed at Purdue for ambient ionization and miniature of mass spectrometers. The proposed product will address the shortcomings of the existing MS products for laboratory and in-field applications and will fulfill an unmet need in the commercial market for drug discovery and clinical analysis. Due to the depth of existing knowledge and the expertise of the team involved, as well as successful preliminary and feasibility studies, PURSPEC is seeking a Direct to Phase II award. The goal of this STTR Direct to Phase II is to develop a complete POC-MS system as a product prototype and its associated operational protocol for chemical analysis at local clinical sites and ultimately for personal health care. Aim 1: Develop a product prototype for POC MS system with improved robustness, enhanced sensitivity and quantitation precisions; Aim 2: Design the sampling cartridge and optimize the sample handling protocol; Aim 3: Develop the software and database supporting the POC-MS system; and, Aim 4: Validate the integrated POC-MS system and analysis protocols. The expected outcome from the Phase II efforts is the delivery of the product prototype of a first POC-MS system with a relatively complete solution for clinical analysis. Immediately following the successfully Phase II, PURSPEC will prepare to commercialize the affordable, easy-to-use and self-contained portable device. A considerable market exists for such a device.