Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices



A new article about sensitization of medical devices using the SkinEthic RHE has been published by Toxicology In Vitro (TIV):


Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices 

C.Pellevoisina F.Cottrezb J.Johanssonc E.Pedersenc K.Colemand H.Grouxb

aEPISKIN, 4, rue Alexander Fleming, Lyon, France
bImmunoSearch, Les Cyclades, Chemin de Camperousse, Grasse, France
cRISE Research Institutes of Sweden AB, Borås, Sweden
dMedtronic plc, Minneapolis, MN, USA 



According to ISO 10993-1:2018, the skin sensitization potential of all medical devices must be evaluated, and for this endpoint ISO 10993-10:2010 recommends the use of in vivo assays.

The goal of the present study was to determine if the in vitro SENS-IS assay could be a suitable alternative to the current in vivo assays.


The SENS-IS assay uses the EpiSkin Large and SkinEthic RHE reconstructed human epidermis models to evaluate marker genes. In our study, the SENS-IS assay correctly identified 13 sensitizers spiked in a non-polar solvent. In a subsequent analysis six medical device silicone samples previously impregnated with sensitizers were extracted with polar and non-polar solvents. The SENS-IS assay correctly identified five of these extracts, while a sixth extract, which contained the weak sensitizer phenyl benzoate, was classified as negative. However, when this extract was concentrated, or a longer exposure time was used, the assay was able to detect phenyl benzoate. The SENS-IS assay was transferred to a naïve laboratory which correctly identified sensitizers in six blinded silicone samples, including the one containing phenyl benzoate. In light of these results, we conclude that the SENS-IS assay is able to correctly identify the presence of sensitizers in medical devices extracts.


To read complete article you can just follow this link on TIV website.