Immunohistochemistry and in situ hybridization are important research and clinical tools in the modern pathology laboratory. Once reserved for leading academic institutions, they are now used on a routine basis in most pathology departments nationwide. The clinical applications of these tests include the areas of cytology, surgical pathology, cytogenetics, and microbiology. The tests pose two problems, however, for clinical laboratories: (1) they are tedious and time consuming to perform on a regular basis, and (2) the technique-dependent aspects of these tests complicates inter-laboratory standardization. The objective of this proposal is to develop the designs and concepts demonstrated from the Phase I effort to a production-ready condition. To accomplish this task, we propose to: 1. Develop and test automated staining protocols for immunohistochemistry, in situ hybridization and certain special chemical stains using the existing prototype. 2. Design the production-ready automated slide stainer. 3. Perform alpha- and beta-site testing. This machine will be used for detection of infectious microorganisms, chromosomal anomalies, oncogenes, and tumor markers. It's unique and proprietary reagent cartridge/liquid dispensing system, coupled with computer control, will make it especially versatile for all of these applications.
