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BioReliance® Launches Ground Breaking 3D Skin Assay

ROCKVILLE, Md., Sept. 5, 2012 /PRNewswire/ -- 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." 

The foregoing release contains forward-looking statements that can be identified by terminology such as "will introduce," "increasingly being used," "continuing demonstration of leadership" or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived there from. You should not place undue reliance on these statements. There can be no guarantee that the Reconstructed Skin Micronucleus Assay will meet the demands of the marketplace. Nor can there be any guarantee that this assay will achieve any particular levels of revenue in the future. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding these products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company's assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich's current Form 10-K on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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