Low Cost Modular Tissue Microarray Instrument

项目总结 要约组织的名称、地址和电话号码 Micatu公司 加拿大路109号 彩绘邮局，纽约14870 办公室：1-888-705-8836 传真：1-888-715-8672 代理机构名称： NCI-DHHS/NIH 征集编号： 小灵通2013-2 主题编号： 项目名称 半自动加温降温组织芯片构建仪 参与项目的关键人员 姓名(名字、中间、姓氏) 迈克尔·雅格尔斯基 普拉丹·阿图尔博士 迈克尔·奥谢茨基 约翰·奥谢茨基 郝焦提，医学博士，博士。 组织 Micatu，Inc. Micatu，Inc. Micatu，Inc. Micatu，Inc. 职位头衔 项目总监 首席科学家 高级工程师 高级工程师 泌尿外科病理科主任 加州大学洛杉矶分校 摘要： 第一阶段研究的目标是设计和制造一种低成本的组织微阵列(TMA)设备，该设备将满足 市场对高质量、快速TMA施工的需求。为此，Micatu Inc.成功开发了一种 已成功展示H&E染色TMA的生产就绪TMA设备和套件(MicaArray)，具有以下特性 90%的样品芯与接收块对齐，95%的样品芯垂直放置，100% 符合要求的TMA分区计数。Micatu的第二阶段开发计划将在这些成功的基础上继续 和快速进展，以提供负担得起的交钥匙工具套件，进一步扩大调查人员的能力 在不依赖昂贵的核心实验室设施的情况下建造自己的TMA，并允许高效、 可靠、低成本的TMA构建，用于验证和在研究和临床环境中使用。这将促进一种 在病理学、组织学、免疫组织化学控制和癌症诊断等领域的应用激增，具有重要的 医疗影响。MicaArray愿景代表了一个基于无缝集成的简单而强大的概念， 用于制造TMA的工具的精密制造和优化。第二阶段的研究计划将完善这部小说 以高精度间隔对准和引导取心针的对准模板，设计和建造了一种新型的， 符合人体工程学的多功能取心和注射针，带有螺纹针系统，允许单个手柄用于 供体块芯的提取和受体块内的注入，经设计验证测试证明具有较低的 使用可加工或注塑塑料进行批量生产的MicaArray设备的成本坚固结构 和可制造性，为铸造TMA块提供定制的低成本模具，设计建造和安装集成的 热电制冷器(TEC)/加热器，可以直接加热和冷却施主和受主块，从而提供一种新的， 强大的、迄今无法提供的电子控制和设计热循环序列的能力，这些序列 最适合石蜡和冷冻(冷冻)嵌入式TMA结构，并在 销售价格比任何市面上可获得的仪器都低30倍。 识别研究或技术的关键词： 组织，微阵列，染色，石蜡，冷冻，受体块，供体块，模板，取芯针，TMA 这项研究的潜在商业应用的简要摘要： Micatu公司的研究计划为学术、临床和研究提供了商业化潜力 市场

PROJECT SUMMARY NAME, ADDRESS, AND TELEPHONE NUMBER OF OFFEROR ORGANIZATION Micatu, Incorporated 109 Canada Road Painted Post, New York 14870 Office: 1-888-705-8836 Fax: 1-888-715-8672 AGENCY NAME: NCI- DHHS/NIH SOLICITATION NUMBER: PHS 2013-2 TOPIC NUMBER: TITLE OF PROJECT Semi-Automated, Heated and Cooled Tissue Microarray Construction Instrument KEY PERSONNEL ENGAGED ON PROJECT Name (First, Middle, Last) Michael Jagielski Atul, Pradhan Ph.D Michael Oshetski John Oshetski Jiaoti Haung, M.D., Ph.D. ORGANIZATION Micatu, Inc. Micatu, Inc. Micatu, Inc. Micatu, Inc. POSITION TITLE Project Director Lead Scientist Sr. Engineer Sr. Engineer Director of Urologic Pathology UCLA ABSTRACT: The objective for the Phase I study was to design and build a low cost Tissue Microarray (TMA) device that would meet market demands for high quality, fast TMA construction. To that end Micatu Inc. has successfully developed a production ready TMA device and kit (MicaArray) that has successfully demonstrated H&E stained TMAs featuring 90% alignment of sample cores to the recipient block, 95% sample core perpendicular placement , and 100% compliance to required TMA sectioning count. Micatu's Phase II development program will continue on these successes and rapid progress to provide an affordable, turnkey instrument suite that further expands investigators' ability to construct their own TMAs without resorting to expensive core laboratory facilities as well as allow for the efficient, reliable, and low cost construction of TMAs for validation and use in research and clinical settings. This will foster a proliferation of applications in fields such as pathology, histology, IHC controls, and cancer diagnosis, having major medical impact. The MicaArray vision represents a simple, yet powerful concept based on seamless integration, precision fabrication, and optimization of tools for constructing TMAs. The Phase II research plan will refine the novel alignment template that registers and guides the coring needle at highly precise intervals, design and build a novel, ergonomic, and versatile coring and injection needle with a threaded needle system that allows for a single handle for both extraction of the donor block cores and injection into recipient block, prove out with design verification testing a low cost rugged construction of the MicaArray device using machinable or injection molded plastic for volume production and manufacturability, provide a custom low cost mold for casting TMA blocks, design build and install an integrated Thermoelectric Cooler (TEC)/Heater that can directly heat and cool donor and recipient blocks thereby providing a new, powerful, and heretofore unavailable capability to electronically control and devise thermal cycling sequences that are optimum for both paraffin and cryo (frozen) embedded TMA construction, and commercialize the MicaArray kit at a sales price that is 30x less than any commercially available instrument. Key words to identify the research or technology: Tissue, microarray, staining, paraffin, cryo, recipient block, donor block, template, Coring Needle, TMA Brief summary of the potential commercial applications of the research: Micatu, Inc. research plan provides commercialization potential to the academic, clinical and research markets