SBIR-STTR Award

Automation of in situ hybridization and antibody mediated stains will be increasingly important in the future as a diagnostic tool in clinical medicine. Immunohistochemistry, a technique once reserved for leading academic institutions, is now routine in most pathology departments nationwide. In a similar manner, in situ hybridization using cDNA probes promises to have tremendous benefits in clinical cytology, surgical pathology, microbiology, and cytogenetics. The objective of this application is to develop an apparatus for automating this difficult and tedious procedure. Automation will achieve both standardization as well as facilitate high volume application of these technological advances. To accomplish this task, the investigators plan to develop further the basic patented innovation of a reversibly applied slide chamber. Phase I objectives are therefore: 1) to design and construct an automated prototypic slide stainer for molecular probes applicable to immunocytochemistry and in situ hybridization; 2) to develop associated computer software and interface electronics; and 3) to test preliminary machine function and optimization for several immunocytochemistry reagent stains. This machine will be used for the detection of infectious microorganisms, chromosomal anomalies, oncogenes, and tumor markers.

Thesaurus Terms:
biomedical equipment, cytogenetics, immunocytochemistry, nucleic acid probe cytodiagnosis, in situ hybridization complementary DNA, computer program /software

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.

Thesaurus Terms:
biomedical automation, biomedical equipment development, histochemistry /cytochemistry, method development, staining computer human interaction, computer program /software, computer programming, cytodiagnosis, cytogenetics, immunocytochemistry, in situ hybridization, reagent /indicator antibody, cryostat, freezing, horseradish peroxidase