INSTRUMENTATION FOR IN SITU ANALYSIS TUMORS

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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.