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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Review and Comment on the Genomic Allergen Rapid Detection Assay

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:

  • Raw data from the study and subsequent nanoString analyses were not provided. A peer review cannot be conducted without access to raw data, necessary to evaluate the appropriateness and consistency of data analysis and processing.
  • The prediction algorithm was not disclosed. This precluded a review of model features typically evaluated by peer review (e.g., statistical robustness of methods used).
  • Eleven of the 28 chemicals used to develop the prediction model were used to evaluate the performance of the model. Chemicals used to develop the prediction model should not be used in an independent evaluation of model accuracy.
  • The applicability domain of the method was not defined.

ICCVAM provided a response to test method developers in April 2018.