MB RESEARCH LABORATORIES, INC. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): The current industry standard for predicting contact
MB RESEARCH LABORATORIES, INC. — SBIR Phase I award from Department of Health and Human Services.
- Amount
- $222,711
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase I
- Solicitation
- PA13-234
- NAICS
- —
- Place of performance
- PA
- Period
- —
Description
DESCRIPTION (provided by applicant): The current industry standard for predicting contact dermal sensitization is the murine Local Lymph Node Assay (LLNA). A significant limitation of the LLNA is the frequency of false positives, as well as the occurrenceof false negatives. This limitation occurs as a result of the LLNA inability to always correctly distinguish between substances that are strongly irritating and those that are sensitizing. The LLNA assesses sensitization by evaluating a dose-response of proliferating lymphocytes within a test group compared to a vehicle control group. Sensitizing substances induce lymphocyte proliferation, but irritating substances can also induce lymphocyte proliferation, thus preventing an accurate classification. Even though over-prediction of substances as sensitizers sounds acceptable, in the context of regulatory guidelines for public safety, this recognized limitation of the LLNA results in a significant issue during testing. Current testing guidelines allow for