INSTRUMENTATION FOR IN SITU ANALYSIS TUMORS

基因（DNA）或基因表达（mRNA）的分析往往是最有用的，如果在细胞的解剖背景下确定的遗传靶点。结果从显微镜载玻片成像。例如，FDA批准的两种检测乳腺癌HER-2过度表达的方法都是原位检测，在切片上进行。乳腺癌的雌激素和孕激素受体检测也是如此。缺乏用于这些类型的原位测试的样品制备仪器已经导致样品处理瓶颈，特别是在高通量基因分析实验室中。此外，它阻碍了这些复杂的测试在临床实验室中的广泛采用。我们提出了一个仪器研究项目，以解决技术挑战，创造一个幻灯片染色原位分子遗传分析。第一阶段的技术挑战涉及微流体领域，并且从未被克服。因此，不存在这样的仪器。我们开发了一种新颖的设计，满足流体处理要求。初步数据表明我们的设计很可能成功.因此，资助该项目可能会导致癌症分子分析的新仪器能力。拟议的商业应用：所提出的仪器是重要的前端，样品制备步骤的基因和基因表达的癌症的高通量分析。

The analysis of genes (DNA) or gene expression (mRNA) is often most informative if the genetic target is identified in the anatomic context of the cell. The result is imaged from a microscope slide. For example, the two FDA-approved tests for her-2 over-expression in breast cancer are both in situ tests, performed on tissue sections mounted on slides. The same is true of the breast cancer tests for estrogen and progesterone receptors. The lack of sample preparation instrumentation for these types of in situ tests has resulted in a sample processing bottleneck, especially in high- throughput gene analysis labs. Moreover, it has hindered the widespread adoption of these sophisticated tests in the clinical laboratory. We propose an instrumentation research project, to solve the technical challenges in creating a slide stainer for in situ molecular genetic analysis. The Phase I technical challenges relate to the field of microfluidics, and have never been overcome. Consequently, no such instrumentation exists. We have developed a novel design that addresses the fluid handling requirements. Preliminary data support the likelihood that Our designs will likely succeed. Funding the project will therefore likely result in a new instrumentation capability for the molecular analysis of cancer. PROPOSED COMMERCIAL APPLICATIONS: The proposed instrumentation is important as a front-end, sample preparation step for high throughput analysis of genes and gene expression in cancer.