Low Cost Modular Tissue Microarray Instrument

项目摘要 报价机构的名称、地址和电话号码 Micatu，Incorporated 加拿大路109号 画后，纽约14870 办公室：1-888-705-8836 传真：1-888-715-8672 机构名称： 国家癌症研究所-卫生部/国家卫生研究所 招标编号： PHS 2013-2 主题编号： 项目名称 半自动加热和冷却组织微阵列构建仪器 参与项目的关键人员 姓名（名、中间名、姓） 迈克尔·贾杰尔斯基 Atul，Pradhan博士 迈克尔·奥谢茨基 约翰·奥谢茨基 Jiaoti Haung，医学博士，博士 组织 Micatu公司 Micatu公司 Micatu公司 Micatu公司 职位名称 项目主任 首席科学家 Sr.工程师 Sr.工程师 泌尿病理学主任 UCLA 摘要： I期研究的目标是设计和构建一种低成本的组织微阵列（TMA）设备， 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 生产就绪的TMA设备和试剂盒（MicaArray）已成功证明H&E染色的TMA， 样品芯与受体块90%对齐，95%样品芯垂直放置，100% 符合要求的TMA切片计数。Micatu的第二阶段开发计划将继续取得这些成功 和快速进展，提供一个负担得起的，交钥匙仪器套件，进一步扩大调查人员的能力， 在不诉诸昂贵的核心实验室设施的情况下， 可靠和低成本的TMA结构，用于研究和临床环境中的验证和使用。这将培养一个 在病理学、组织学、IHC控制和癌症诊断等领域的应用激增， 医学影响。MicaArray的愿景代表了一个基于无缝集成的简单而强大的概念， 精确制造和优化用于构建TMA的工具。第二阶段的研究计划将完善小说 对准模板以高度精确的间隔配准和引导取芯针，设计和构建一种新颖的， 符合人体工程学和多功能的取芯和注射针，具有螺纹针系统， 无论是供体区块岩心的提取，还是注入受体区块，都通过设计验证试验证明， MicaArray器械采用可机加工或注塑成型塑料进行批量生产， 和可制造性，提供用于铸造TMA块的定制低成本模具，设计建造和安装集成的 热电冷却器（TEC）/加热器，其可以直接加热和冷却供体和受体块， 电子控制和设计热循环顺序的能力， 最适合石蜡和冷冻（冷冻）包埋的TMA构建，并以100万美元的价格将MicaArray试剂盒商业化。 销售价格比任何市售仪器低30倍。 识别研究或技术的关键词： 组织、微阵列、染色、石蜡、冷冻、受体组织块、供体组织块、模板、取芯针、TMA 本研究潜在商业应用的简要总结： Micatu公司研究计划为学术、临床和研究提供商业化潜力 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