ICCVAM welcomes submissions of innovative test methods that might be acceptable for specific regulatory use and for which adequate validation studies have been completed. To maximize effective implementation of new test methods or approaches, however, ICCVAM evaluates and recommends only those test methods proposed for regulatory uses that align with ICCVAM member agencies’ needs and priorities. More information on ICCVAM test method submissions is available.
In FY 2018, the Genomic Allergen Rapid Detection (GARD™) assay was submitted by SenzaGen AB to ICCVAM to evaluate its ability to identify potential skin sensitizers. The ICCVAM Skin Sensitization Workgroup reviewed and discussed a validation study report provided by SenzaGen and in response to SenzaGen note deficiencies in the validation that precluded a recommendation being made on the assay. Ongoing ICCVAM test method evaluation activities in FY 2018 are summarized below.
Test Method Evaluation Activities in FY 2018
|Test Method||ICCVAM Recommendations/Agency Status|
|Electrophilic allergen screening assay||This test method, nominated by the National Institute for Occupational Safety and Health (NIOSH), is an in chemico assay intended to identify potential skin sensitizers.
A validation study of the method began in FY 2017 with four ICCVAM agencies participating in the study. NICEATM is coordinating the study, and members of the ICCVAM Skin Sensitization Workgroup are serving on the study management team.
Phase 1 testing of 10 chemicals during FY 2018 showed that the method had sufficiently good reproducibility and accuracy rates to support further evaluation. Phase 2 testing will begin after a 96-well format is developed to increase throughput and accessibility of the assay.
|OptiSafe||NICEATM coordinated a multi-laboratory validation study to determine the reliability and relevance of the OptiSafe test method. In this method, a test substance is applied to a semi-permeable membrane to assess the substance’s potential to cause eye irritation.
Testing was completed on 95 coded chemicals in three phases during FY 2018; a report on the study will be submitted for publication in FY 2019.
|EpiAirway™||A cooperative agreement under the NIEHS Phase IIb Small Business Innovation Research provides funding to MatTek Corporation to validate its EpiAirway™ in vitro human bronchial tissue model to predict the toxicity of inhaled chemicals.
Several ICCVAM agency representatives are members of the cooperative agreement steering committee. Testing is ongoing with chemicals selected by steering committee members.
NICEATM provides scientific oversight of this NIEHS small business program supporting validation of alternative test methods.