SBIR-STTR Award

This project is for the development of an automated color based micronuclei assay system based on results of a prototype MS-DOS color analysis system. The system will automatically locate and count polychromatic erythrocytes (PCE's), micronucleated polychromatic erythrocytes (MPCES) and normochromatic erythrocytes (NCEs). During Phase I, a number of critical variable parameters previously developed will be adapted into a user-friendly interactive program capable of rapidly selecting the appropriate parameters for each new slide preparation. These parameters include: the level of background strain; criteria for acceptable erythrocyte size range and roundness; and color discrimination. Color discrimination is the key element for differentiation. The system will be implemented on a MacIntosh IIFX computer. It will include a capability to automatically process multiple slides and produce automatic reports including appropriate statistical analysis. By capturing all images with scored micronuclei the system provides a necessary audit trail for regulatory overview.Awardee's statement of the potential commercial applications of the research:The potential market for an image based micronuclei analysis systems is large and growing; extending to both drug and chemical manufactures, research organizations and government regulatory agencies. In Japan, the micronuclei assay is a required test for toxic effect.National Institute of Environmental Health Sciences (NIEHS)

The overall objective of Phase II is the completion and validation of an automated color-based Micronuclei Assay System. Current federal plans include extensive use of the MNA to determine the potential genetic toxicity of various chemicals and drugs. The automation of MNA, based on color separation of polychromatic erythrocytes and normochromatic erythrocytes in bone marrow and peripheral blood preparations, provides consistent unbiased scoring of erythrocytes and micronuclei. A new 160-slide changer is under development and allows total experiment operation without manual interruption, allowing a system to operate within and outside of normal working hours. Automation produces significantly improved statistics with significantly reduced manpower requirements. There is a large and building commercial requirement for these systems both in the U. S. and Japan.Awardee's statement of the potential commercial applications of the research: The National Toxicity Program has identified in vivo cytogenic tests (Micronucleus Assay) as providing effective and reproducible means to detect genetic toxicity of chemicals in whole animals. MNA is widely used in the U. S. and worldwide. Automated, statistically reliable techniques for color-based MNA are commercially important in preclinical trials, in development testing in the pharmaceutical industry and in government agencies cited with the regulatory oversight function.National Institute of Environmental Health Sciences (NIEHS)