The SENS-IS Assay

We have developed SENS-IS, a method based on the quantitative analysis of specific biomarkers expressed in 3D reconstructed epidermis. The use of a reconstructed 3D human epidermis as the test system allows the testing of chemicals/ingredients under conditions close to the human use. Using this approach, the SENS-IS assay can also be used for the measurement of chemical sensitizing potency. The end point analysis measures the quantitative overexpression of a carefully selected set of 65 biomarkers regrouped into three subsets to take into account the irritation potential and the diversity of chemical induction of skin sensitization. The performance of the SENS-IS assay was evaluated here with a subset of 41 chemicals. Its hazard and potency predictivity as compared to the corresponding LLNA data were, respectively, of 97.5% and 90.2%. The reproducibility and predictivity of the SENS-IS assay have been evaluated during a ring study organized with three laboratories. The SENS-IS assay was shown to be robust and transferable and delivered results that compared very well with corresponding human sensitization data.