Mesodissection Device Phase II

介层解剖装置第二期

• 批准号: 8524438
• 负责人: Nils B Adey
• 金额: $ 59.75万
• 依托单位: AVANSCI BIO, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524438
• 关键词: Adoption; American Association of Cancer Research; Area; Biochemical; Biological Assay; Cancer Diagnostics; Cell physiology; Cells; Clinical; Clinical Research; Complex; Computer software; Development; Devices; Diabetes Mellitus; Diagnostic; Disease; Dissection; Documentation; Ensure; Evaluation; Feedback; Frozen Sections; Funding; Future; Glass; Goals; Grant; Hardness; Heart Diseases; Histopathology; Immobilization; Lasers; Liquid substance; Malignant Neoplasms; Manuals; Market Research; Marketing; Mass Spectrum Analysis; Measures; Methods; Microdissection; Microscopic; Molecular Analysis; Movement; Normal Cell; Peer Review; Performance; Phase; Preparation; Productivity; Progress Reports; Protein Analysis; Publications; Recovery; Research; Research Personnel; Research Support; Resolution; Running; Sampling; Site; Slide; Small Business Innovation Research Grant; Staging; System; Techniques; Technology; Testing; Time; Tissues; Validation; Work; biological research; commercialization; cost; design; expectation; improved; instrument; instrumentation; interest; laser capture microdissection; meetings; molecular pathology; new technology; next generation sequencing; novel; performance tests; posters; pressure; prototype; public health relevance; research study; success; usability; web site

DESCRIPTION (provided by applicant): Microscopic analysis of tissue mounted on glass slides is commonly used to study cancer, non-neoplastic entities such as heart disease and diabetes, and normal cell function. Researchers utilize micro and macro tissue dissection techniques in order to recover specific areas of these tissue sections from the slides for subsequent molecular analysis including real time PCR, microarrays, sequencing, and mass spectrometry. When the area to be dissected is relatively large (a few mm), manual macrodissection is adequate. If single cell resolution is required, Laser Microdissection (LMD) is often employed. Both of these methods have their short comings, particularly when an intermediate level of resolution is needed (100¿m to 1 mm). The Phase II project continues the goal to develop the MESO system, which is an affordable, easy to use, tissue milling and fragment recovery technology for slide mounted tissue sections. AvanSci Bio has met the Specific Aims of the Phase I grant by developing the manufacturing prototype and successfully completing the planned performance evaluation experiments. However, challenging improvements in accuracy, resolution, and sample preparation methods are necessary to expand the usability of the MESO system. In addition, significantly more testing and validation are necessary to ensure the system performs reliably and up to expectations and to encourage adoption. The two Specific Aims of this Phase II include: 1) optimization of sample prep and milling conditions, beta site testing including performance evaluation and validation, and novel application development; and 2) design refinement primarily to the stage precision and blade pressure control, and improved hardness of xScisor blade and more refined fluid control. This new technology and product is expected to further research and clinical diagnostics by greatly reducing the cost and therefore broadening availability of high performance microdissection. We have demonstrated feasibility for Phase II development and commercialization. Our Phase III goal will be to ultimately manufacture and distribute the MESO System, including instrumentation, software, and consumables to clinicians and researchers doing slide mounted tissue dissection.

描述（由申请方提供）：载玻片上组织的显微镜分析通常用于研究癌症、非肿瘤实体（如心脏病和糖尿病）以及正常细胞功能。研究人员利用微观和宏观组织解剖技术，以便从载玻片上恢复这些组织切片的特定区域，用于随后的分子分析，包括真实的时间PCR、微阵列、测序和质谱。当要解剖的区域相对较大（几mm）时，手动宏观解剖就足够了。如果需要单细胞分辨率，通常采用激光显微切割（LMD）。这两种方法都有其短的分辨率，特别是当需要中等分辨率（100 μ m至1 mm）时。第二阶段项目继续开发MESO系统的目标，这是一种经济实惠、易于使用的组织研磨和碎片回收技术，用于载玻片组织切片。AvanSci Bio通过开发制造原型并成功完成计划的性能评估实验，达到了第一阶段赠款的具体目标。然而，有必要在准确度、分辨率和样品制备方法方面进行具有挑战性的改进，以扩大MESO系统的可用性。此外，还需要进行更多的测试和验证，以确保系统可靠地运行并达到预期，并鼓励采用。第二阶段的两个具体目标包括：1）优化样品制备和研磨条件，进行包括性能评估和验证在内的β现场测试，以及开发新的应用程序; 2）主要针对载物台精度和刀片压力控制进行设计改进，并提高xScisor刀片的硬度和更精细的流体控制。这种新技术和产品有望通过大大降低成本来进一步研究和临床诊断，从而扩大高性能显微切割的可用性。我们已经证明了第二阶段开发和商业化的可行性。我们的第三阶段目标是最终制造和分销MESO系统，包括仪器、软件和耗材，供临床医生和研究人员进行载玻片组织切割。