We now offer access to the GARD® technology platform, a second generation of in vitro assays for skin sensitization testing based on genomics and machine learning.
The GARD® technology platform, developed by SenzaGen AB, is intended to gradually replace all animal-based testing components with human equivalents, enabling truly animal-free skin sensitization testing, benefitting animal welfare and human health.
From a regulatory perspective, GARD® skin sensitization testing conforms with ISO 10993 standards and is the first and only non-animal OECD-approved test for assessing the allergenicity of chemicals based on genomics and machine learning.
A better understanding of the biological mechanism that causes skin sensitization has led to significant progress in developing and the regulatory implementation of New Approach Methodologies (NAMs) for this endpoint. These methodologies include computational models and cell/tissue in vitro-based assays. In addition to not testing on living animals, NAMs also have the benefit of generating more human-relevant information.
At its core, the GARD® technology platform uses an analysis of a human cell’s total response when exposed to different substances and has four key elements:
- a biological cell system based on a human dendritic-like cell line, mimicking critical parts of the immune system and recognizing allergens
- a dataset for biomarker discovery and subsequent machine learning training
- a gene expression pattern to establish a genomic biomarker signature
- a prediction model to perform future classification of the test chemicals
These four elements are key to improved accuracy and human relevance, as they combine the simplicity of in vitro methods and the biological intricacy of in vivo models.