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| We’re proud to share how our innovative GARD® method is addressing key challenges in skin sensitization testing. In Q4, we’ve focused on filling data gaps in areas like Medical Devices, Safe Dose Levels, and Complex Mixtures—driving the shift to reliable, human-relevant solutions. |
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Progress is underway to integrate New Approach Methodologies (NAMs) into skin sensitization testing standards for Medical Devices within ISO. At the recent ISO TC 194/WG 8 meeting in Paris, SenzaGen’s Andy Forreryd presented data from the GARD®skin Medical Device pre-validation study—an important step toward its inclusion in the normative section of ISO 10993-10. Since 2021, GARD®skin has been recognized in Annex C of the standard, and its further integration underscores the advancement of NAMs in improving biological safety assessments while reducing reliance on animal testing.
Explore how you can use in vitro methods for Biocompatibility testing |
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At the recent ASCCT conference, SenzaGen presented exciting new data on assessing skin sensitizing potency, including a poster that highlighted the GARD®skin Dose-Response assay's performance on the Reference Chemical Potency List (RCPL). Further confirmation of the assay’s effectiveness comes from two recent publications, developed in collaboration with industry leaders L'Oréal, RIFM, and IFF. These studies demonstrate the assay’s ability to:
- Support UN GHS/CLP classification: 1A (strong) and 1B (weak)
- Predict LLNA EC3 and human NESIL/NOEL values
- Derive Points-of-Departure (PoD) for Quantitative Risk Assessment
Access our latest publications for more insights |
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In our latest webinar, we explored advancements in skin sensitization testing, focusing on challenging samples—specifically, substances that fall outside the applicability domains of conventional in vitro assays outlined in OECD Test Guidelines.
GARD®skin (OECD TG 442E) stands out as a reliable method for testing complex mixtures like natural extracts, backed by scientific data and successful industry collaborations.
Contact us for a case study on Natural Extracts |
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