21st Century Sensitisation testing: Can one test be stand alone? Regulatory challenges and GARD applications update
Presenter: Henrik Appelgren and Hanna Frykman, SenzaGen, Sweden
Allergy is a growing health problem in humans. The data requirements for the assessment of sensitisation in chemical legislations have been based on animal assays, which until now have served as the golden standard. However, in vitro assays have been developed which need to be combined in order to address all key events for sensitisation to fulfil the demands in e. g., Reach. However, The Genomic Allergen Rapid Detection Skin (GARDskin) assay addresses all the key regulatory questions regarding sensitisation, including potency – How?
This session we will give an update on the validation status and the different applications of GARD.