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Pre-validation of Tissue Specific Micronucleus Assay for Genotoxicity Testing

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
80251
Program Year/Program:
2006 / SBIR
Agency Tracking Number:
ES015002
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MATTEK CORPORATION
200 HOMER AVE ASHLAND, MA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2006
Title: Pre-validation of Tissue Specific Micronucleus Assay for Genotoxicity Testing
Agency: HHS
Contract: 1R43ES015002-01
Award Amount: $207,730.00
 

Abstract:

DESCRIPTION (provided by applicant): Safety assessment of any new product for human use requires genotoxicity testing to insure that the product is not carcinogenic. Current genotoxicity assays are based on bacterial or non-human cell systems. Such tests are sensitive but give very low specificity (high rate of false positive results). Hence important new chemicals (possibly life-saving drugs) may be eliminated from further development. Animal systems, e.g., rodents, are also used; however, beginning in 2009, legislation in Europe will prevent manufacturers from marketing cosmetics products that have been tested using animals. Given today's global economy, this legislation will directly affect the vast majority of US companies. Finally, for topically applied dermatologic or cosmetic materials, a test which determines genotoxicity to the skin that utilizes a system with inherent metabolic activity would be optimal. The overall goal of this proposal is to develop a skin specific genotoxicity assay. An in vitro highly differentiated skin equivalent tissue will be used to accurately determine the genotoxicity following topical exposure. Based on significant preliminary results, it is likely that this research will result in a human in vitro, skin-specific micronucleus (INVSSMN) assay which will replace current in vitro and animal-based genotoxicity tests. The INVSSMN test will overcome the low levels of specificity of current test methods and avoid animal welfare issues. The specific aims of the Phase I proposal are to: (1) evaluate the INVSSMN assay for a battery of 10 known genotoxins and 5 non-genotoxic chemicals; (2) evaluate INVSSMN assay for a battery of 10 genotoxic chemicals that are known to require metabolic activation to become mutagens; (3) investigate reproducibility of reconstructed skin genotoxicity test; and (4) automate analysis and scoring. Safety assessment of all new products for human use requires a genotoxicity testing to insure that product is not carcinogenic. Current methods are not tissue and human specific which results in extremely low level of specificity and elimination of important substances from further development. We will develop skin-specific micronucleus assay by utilizing in vitro human reconstructed skin model to overcome low levels of specificity of current test methods and avoid animal welfare issues.

Principal Investigator:

Yulia Kaluzhny
5088816771
ykaluzhny@mattek.com

Business Contact:

Mitchell Klausner
5088816771
MKLAUSNER@MATTEK.COM
Small Business Information at Submission:

MATTEK CORPORATION
MATTEK CORPORATION 200 HOMER AVE ASHLAND, MA 01721

EIN/Tax ID: 042877744
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No