NEW METHOD FOR DETECTING CANCER AND VIRAL INFECTD CELLS

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Phase I research is aimed at developing a rapid, automated method to analyze DNA or RNA aberrations in isolated nuclei or cells using microencapsulation technology, fluorescence in situ hybridization (FISH) and flow cytometry. This novel microdrop in situ hybridization method (MISH) is expected to improve early disease detection and to contribute to genomic and cytogenetic research. Since individual, chromosomes, cells and nuclei do not withstand hybridization conditions in solution, use of flow cytometry for chromosome analysis is not currently feasible. In contrast with microscopy and more recently digital image analysis, this high throughput analytical technique is distinctive in its ability to rapidly analyze large numbers of biological entities and to quantitate small sub-populations. Adaptation of FISH procedures for flow cytometric use would dramatically expand the number of assays which could be performed for research and clinical cytogenetics. Genetic aberrations are implicated in a variety of disease states, including tumorigenesis, metastasis, and leukemias. Detection of rare cells, which are expressing virus specific RNAs or not expressing host- coded genes, such as tumor suppressor genes, could also be dramatically improved using this unique technology. An additional application includes qualitative or quantitative analyses of cells expressing specific mRNA levels for both research and clinical applications. Cytogenetic testing is still in its infancy. Discovery of new genes and their functions are the focus of intensive efforts by pharmaceutical companies and genome researchers. These therapeutic efforts are also expected to support rapid development of new assay methods for genetic testing. PROPOSED COMMERCIAL APPLICATION: Molecular cytogenetic testing is in its infancy. Development of rapid, high throughput assay methods for detecting gene aberrations present in low numbers will improve diagnosis and therapeutic drug development. The market for FISH assays is expected to increase to $1.0 billion annually by 2010.