Mesodissection Device Phase II

描述（由申请人提供）：安装在玻片上的组织显微分析通常用于研究癌症，非肿瘤性实体，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，以便从载玻片中恢复这些组织切片的特定区域，用于随后的分子分析，包括实时PCR，微阵列，测序和质谱分析。当待解剖区域相对较大（几毫米）时，手动宏观解剖就足够了。如果需要单细胞分辨率，通常采用激光显微解剖（LMD）。这两种方法都有它们的缺点，特别是当需要一个中等水平的分辨率（100米到1毫米）时。第二阶段项目的目标是继续开发MESO系统，这是一种经济实惠、易于使用的组织铣削和碎片恢复技术，适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，实现了第一阶段拨款的具体目标。然而，为了扩大MESO系统的可用性，需要在精度、分辨率和样品制备方法方面进行具有挑战性的改进。此外，需要更多的测试和验证，以确保系统可靠地执行，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，beta现场测试，包括性能评估和验证，以及新的应用开发；2)设计上的改进主要集中在工作台精度和刀片压力控制上，提高了xScisor刀片的硬度，流体控制更精细。这项新技术和产品有望通过大大降低成本，从而扩大高性能显微解剖的可用性，进一步研究和临床诊断。我们已经证明了二期开发和商业化的可行性。我们的第三阶段目标是最终生产和销售MESO系统，包括仪器、软件和耗材，供临床医生和研究人员进行切片组织解剖。

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.