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Local Lymph Node Assay with IL-18 Endpoints

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AI108208-01A1
Agency Tracking Number: R43AI108208
Amount: $222,711.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA13-234
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
1765 WENTZ ROAD, PO BOX 178, SPINNERSTOWN, PA, 18968-0178
DUNS: 77070712
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (215) 536-4110
Business Contact
Phone: (215) 536-4110
Research Institution
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

* Information listed above is at the time of submission. *

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