GARDskin Dose-Response

The GARDskin Dose Response (DR) method is a transcriptomics-based in vitro assay measuring with a NanoString nCounter instrumentation the transcriptional levels of a panel of genes called the GARDskin Prediction Signature (GPS). It is a variation of the established GARDskin assay (TSAR TM2011-09; OECD TG 442E) for skin sensitisation assessment. Consistently with the GARDskin, the GARDskin DR addresses the third key event of the skin sensitisation Adverse Outcome Pathway (activation of dendritic cells). It uses the very same cell system (a subclone of the MUTZ-3 cell line), protocols, and analysis pipeline, but instead of testing at a single concentration as in the traditional GARDskin, it measures gene expression across a range of concentrations. In addition, it provides an add-on to the established prediction model allowing to convert the data into a "Predicted Potency Value" which is proposed for discriminating between UN GHS subcategory 1A skin sensitisers from those not categorised as subcategory 1A i.e., subcategory 1B or no category.