Human relevant data for safer products
Allergic contact dermatitis is the most prevalent form of immunotoxic adverse effects induced by chemicals in consumer products and everyday surroundings.
For patient safety all medical device classified products need to be evaluated for the endpoint skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018).
GARD®skin Medical Device enables a robust and accurate way of predicting the ability of chemicals to induce sensitization, in this case leachables in extracts of Medical Device classified product, without the use of animal experimentation in compliance with the 3R principle.
It is a genomic based test measuring changes in gene expression of 200 genes relevant to the skin sensitization adverse outcome pathways (AOP) and can be used for skin sensitization testing in the Biological Evaluation of Medical Devices according to ISO 10993.