Sigma-Aldrich® Corporation (NASDAQ: SIAL) today announced that its recent acquisition, BioReliance, the biopharma and early development services business under SAFC, will introduce a new assay to detect DNA damage from products with dermal routes of exposure. The Reconstructed Skin Micronucleus (RSMN) Assay represents the first commercial offering of a Genetic Toxicology assay using three-dimensional tissue models.
The RSMN Assay uses the EpiDerm™ three-dimensional skin model, developed by global tissue engineering industry leader, MatTek. Three-dimensional models are increasingly being used in predictive toxicology, as they require no animal models, more closely resemble human organs, and have proven to be more predictive than other in vitro models.
BioReliance has performed extensive qualification studies of this assay using chemicals with defined genotoxicity/carcinogenicity and has developed a robust Good Laboratory Practices (GLP) protocol. The results of these studies have been presented in numerous meetings, including sessions at the Society of Toxicology (SOT), Environmental Mutagen Society (EMS), and International Life Science Institute (ILSI)/In Vitro Genetic Toxicity (IVGT) meetings; as well as posters, most recently presented at the Congress of the European Society of Toxicology Annual Meeting, Eurotox 2012 and the United Kingdom EMS meeting.
"We are very proud to introduce this novel genotoxicity assay that represents a paradigm shift from traditional genotoxicity testing, and a step forward in further contributing to the 'three R's' of reduce/refine/replacement of animal tests," said Executive Director for Early Development Services, Daniel Aparicio. "BioReliance places significant emphasis on the development of new assays and innovative technologies. The RSMN Assay is the latest endeavor in our continuing demonstration of leadership in Genetic Toxicology."
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