USA flag logo/image

An Official Website of the United States Government

Reconstructed Skin Micronucleus Genotoxicity Assay

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
80251
Program Year/Program:
2009 / 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 2
Fiscal Year: 2009
Title: Reconstructed Skin Micronucleus Genotoxicity Assay
Agency: HHS
Contract: 2R44ES015002-02A1
Award Amount: $819,104.00
 

Abstract:

DESCRIPTION (provided by applicant): As part of a standard toxicological evaluation, all new products must be tested to insure they are not genotoxic. Animal tests are available but European legislation that takes effect in 2009 will ban animal testing. T his legislation will affect almost all large US multinational personal care, cosmetic, and pharmaceutical companies. Non-animal, in vitro tests exist; however, they lack specificity and result in an unacceptably high rate of false positives. This leads to a large number of materials being excluded from further development even though are safe. The long term goal of the proposal is to validate an in vitro test method to accurately determine human skin genotoxicity. Phase 1 research made significant progress in developing a reconstructed skin micronucleus (RSMN) assay for genotoxicity testing. A standardized protocol, a pre- screen cytotoxicity assay, and a prediction model (based on statistically significant increases in micronuclei in dividing cells) were de fined and tested. A previously published method was improved to increase the sensitivity of the assay for detecting genotoxins requiring metabolic activation. In addition, long term reproducibility studies utilizing tissue from multiple donors showed highl y reproducible results. Phase 2 will further build on Phase 1 results to optimize the assay method, automate scoring, expand the database of materials tested, demonstrate interlaboratory reproducibility, and adapt the assay to a high throughput format. The se studies will lay the groundwork for formal validation and regulatory acceptance of the assay. PUBLIC HEALTH RELEVANCE: Current genotoxicity test methods rely on animals or in vitro tests. However, the in vitro methods give an unacceptable percentage of false positive test results and animal testing will be banned for US based multinational companies due to pending legislation. This project will develop an in vitro assay which accurately predicts human genotoxicity.

Principal Investigator:

Yulia Kaluzhny
5088816771
YKALUZHNY@MATTEK.COM

Business Contact:

Mitchell Klausner
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