The in vivo micronucleus (MN) assay is a widely used test to screen compounds for chromosome-damaging activity. It is also a key test for the registration of new pharmaceuticals. Litron Laboratories has developed an automated method of scoring MN using flow cytometry (FCM). This system has several benefits: increased numbers of cells analyzed, ability to process more samples in less time, and objective analysis/scoring. In Phase II work Litron will perform experiments designed to validate their kit for scoring MN. Specifically, they and their collaborators will: analyze genotoxic compounds with different modes of action, perform the entire assay from animal dosing to blood fixation and analysis, perform microscopic evaluations of these same blood samples for comparison with FCM, measure interlaboratory variability, and prepare a document to submit to ICCVAM for regulatory approval.

Proposed Commercial Applications

The validation and regulatory approval of Litron's FCM based MN assay would result in increased sales of Litron's developed mouse peripheral blood MN analysis kits. Similar studies are planned for analysis kits to measure MN in mouse and rat bone marrow, rat peripheral blood and also human peripheral blood. Enormous commercial opportunity exists from the sale of these kits.

Agency
National Institute of Health (NIH)
Institute
National Institute of Environmental Health Sciences (NIEHS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44ES011244-02
Application #
6403333
Study Section
Special Emphasis Panel (ZRG1-SSS-U (10))
Program Officer
Heindel, Jerrold
Project Start
2001-09-30
Project End
2003-09-29
Budget Start
2001-09-30
Budget End
2002-09-29
Support Year
2
Fiscal Year
2001
Total Cost
$265,514
Indirect Cost
Name
Litron Laboratories, Ltd.
Department
Type
DUNS #
City
Rochester
State
NY
Country
United States
Zip Code
14623
Torous, Dorothea K; Hall, Nikki E; Illi-Love, Anne H et al. (2005) Interlaboratory validation of a CD71-based flow cytometric method (Microflow) for the scoring of micronucleated reticulocytes in mouse peripheral blood. Environ Mol Mutagen 45:44-55
Dertinger, Stephen D; Camphausen, Kevin; Macgregor, James T et al. (2004) Three-color labeling method for flow cytometric measurement of cytogenetic damage in rodent and human blood. Environ Mol Mutagen 44:427-35