Low Cost Modular Tissue Microarray Instrument

低成本模块化组织微阵列仪器

• 批准号: 8893922
• 负责人: Michael T Jagielski
• 金额: $ 75.07万
• 依托单位: MICATU, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-17 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8893922
• 关键词: Applications Grants; Biological Assay; Clinical; Clinical Research; Custom; Development; Devices; Fluorescent in Situ Hybridization; Fostering; Freezing; Goals; Health; Heating; Hematoxylin and Eosin Staining Method; Histology; Immunohistochemistry; Injection of therapeutic agent; Legal patent; Marketing; Medical; Methods; Microscope; Microtome - medical device; Molds; Needles; Paraffin; Pathology; Pattern; Performance; Phase; Plastics; Price; Production; Program Development; Research; Research Personnel; Resort; Sales; Sampling; Slide; Staining method; Stains; System; Technology; Testing; Tissue Microarray; Tissues; Validation; Vision; Work; base; cancer diagnosis; clinical application; commercial application; commercialization; cost; design; ergonomics; instrument; laboratory facility; meetings; novel; phase 1 study; programs; prototype; success; tool

DESCRIPTION (provided by applicant: 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

描述（由申请人提供）：I期研究的目的是设计和构建低成本组织微阵列（TMA）器械，以满足市场对高质量、快速TMA构建的需求。为此，Micatu Inc.成功开发了一种生产就绪的TMA设备和套件（MicaArray），该设备和套件已成功证明H&E染色的TMA具有90%的样品芯与受体块对齐，95%的样品芯垂直放置，以及100%符合要求的TMA切片计数。Micatu的第二阶段开发计划将继续这些成功和快速进展，以提供一个负担得起的交钥匙仪器套件，进一步扩大研究人员的能力， 拥有自己的TMA，而无需求助于昂贵的核心实验室设施，以及允许高效，可靠和低成本的TMA的建设，以验证和使用在研究和临床环境。这将促进病理学、组织学、IHC控制和癌症诊断等领域的应用扩散，具有重大的医学影响。MicaArray的愿景代表了一个简单而强大的概念，它基于无缝集成、精密制造和优化构建TMA的工具。II期研究计划将完善新型对准模板，该模板以高度精确的间隔配准和引导取芯针，设计和构建新型、符合人体工程学且多功能的取芯和注射针，其具有螺纹针系统，允许单个手柄用于提取供体块芯和注射到受体块中，通过设计验证测试证明了MicaArray器械的低成本坚固结构，使用可加工或注塑成型塑料进行批量生产和可制造性，提供了用于铸造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块和受体块，从而提供新的、强大的且迄今为止不可用的能力来电子控制和设计对于石蜡和低温（冷冻）包埋的TMA构造都是最佳的热循环顺序，并以比任何市售仪器低30倍的销售价格将MicaArray试剂盒商业化。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研究潜在商业应用的简要总结：Micatu，Inc.研究计划为学术、临床和研究市场提供商业化潜力