Webinar: Safer Medical Devices
Safer Medical Devices – in vitro skin sensitization testing with human relevance and high accuracy
By Rose-Marie Jenvert, PhD, and Joshua Schmidt, PhD, SenzaGen
Watch by clicking the image below.
In vitro skin sensitization testing of Medical Devices using GARD™
Rose-Marie Jenvert, Angelica Johansson, Olivia Larne, Emelie Danefur, Emil Altonen, Anders Jerre, Robin Gradin, Gunilla Grundström.
SenzaGen, Lund, Sweden.
Introduction
All medical devices need to be evaluated for the end point skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018), today commonly involving in vivo assays. Here, we show that the in vitro assay GARDskin Medical Devices can classify leachables as either skin sensitizers or non-sensitizers in polar and non-polar extraction of Medical Devices.
Conclusion
GARDskin Medical Device
- is an in vitro alternative for assessment of skin sensitization of Medical Devices
- is compatible with the extraction vehicles salin, olive oil and sesame oil.
Poster presented at Eurotox, Helsinki, Sep 9, 2019.
Extended applicability domain with new solvent selection for the GARD platform
Jenvert RM, Larne O, Torstensdotter MattssonU. I., Johansson H, SenzaGen, Lund, Sweden
Introduction
The Genomic Allergen Rapid Detection (GARD) assay is a state of the art in vitro assay developed for the assessment of skin sensitizers. It is based on gene expression analysis of SenzaCells, a human myeloid cell line, after stimulation by the test item.
During the development of the GARD platform, two solvents were used; DMSO (0.1%) and Water. To increase the applicability domain of GARD® and the solubility of certain test items, for e.g. Medical Device extracts and UVCBs, we here show a broader range of solvents compatible with GARD.
Conclusions
Here, we show that the GARD® platform is compatible with the following solvents:
• Acetone
• Ethanol
• Glycerol
• Super refined olive oil
• DMF
• DMSO
• Water
• Isopropanol
