(Applicant?s abstract): Although the murine Local Lymph Node Assay (LLNA) is effective at detecting potential irritants/sensitizers, this assay, in its current standard form: 1) cannot readily differentiate some types of irritants from respiratory and contact sensitizers; 2) utilizes moderate amounts of radioactive material and; 3) requires increased numbers of animals to determine the different endpoints (i.e., proliferation, immunophenotype) to fully characterize the response of an animal to a topically-applied chemical. To enhance and improve this important test, our company has implemented several innovative modifications to the standard LLNA. We have applied flow cytometric techniques to this assay to increase the sensitivity/specificity of the assay, eliminate the use of radioactive material and decrease the number of animals used for screening. It has been determined by the results of SBIR Phase I studies that the proposed enhanced flow cytometry-based LLNA is technically and commercially feasible. However, to develop this assay to its full commercial potential, which our company would provide to the chemical, pharmaceutical and consumer products industries, our group must: 1) validate the enhanced version of the LLNA; 2) establish the cytometry-based LLNA as a GLP compliant assay at our company and; 3) develop and provide various versions of the enhanced LLNA for our clients.

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 #
5R44ES010234-04
Application #
6757865
Study Section
Special Emphasis Panel (ZRG1-SSS-3 (10))
Program Officer
Heindel, Jerrold
Project Start
2002-09-30
Project End
2005-03-31
Budget Start
2004-04-01
Budget End
2005-03-31
Support Year
4
Fiscal Year
2004
Total Cost
$266,597
Indirect Cost
Name
MB Research Laboratories, Inc.
Department
Type
DUNS #
077070712
City
Spinnerstown
State
PA
Country
United States
Zip Code
18968