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The ICCVAM Skin Sensitization Workgroup reviewed the validation study report of the Genomic Allergen Rapid Detection™ assay for skin sensitization potential. This method measures changes in gene expression for 200 genes relevant to skin sensitization in a human myeloid leukemia cell line after the exposure of the cells to test substances.
The review of the validation study report started in February 2018. The ICCVAM workgroup did not support a further comprehensive assessment and peer review of this method, based on a number of considerations:
ICCVAM provided a response to test method developers in April 2018.