ST. LOUIS, Aug. 28, 2013 /PRNewswire/ -- Sigma- Aldrich ® Corporation's (NASDAQ: SIAL) BioReliance ® ( www.bioreliance.com), the biologics and early-development services business under SAFC ® ( www.sigmaaldrich.com/safc), has qualified the Big Blue ® Mouse Transgenic Rodent Mutation (TRM) assay to meet the new Organization for Economic Co-Operation and Development (OECD) Test Guideline 488 requirements for evaluation of in vivo mutagenicity.
Big Blue is identified in OECD Test Guideline 488, as well as recommended by various agencies and expert groups, including the European Chemicals Agency, as an accepted assay for evaluating mutagenicity in somatic and male germ cell tissues. BioReliance confirms that the Big Blue Mouse TRM assay service is immediately available.
BioReliance acquired the exclusive ownership of the Big Blue TRM assay and rodents from Agilent in March 2013. The assay service fulfills a specific need of pharmaceutical and chemical companies by providing a unique confirmatory test for drugs and chemicals that initially test positive in in vitro mutation assays.
"We are pleased to offer this critical service to our clients," stated Robert Young, study director for TRM assays at BioReliance. "Our company played a key role in the development and validation of the model in the early 1990s. We have now expanded our expertise by updating and qualifying the assay to meet the requirements of OECD 488, additional regulatory guidelines and the current needs of our clients. This new service complements BioReliance's existing portfolio of comprehensive genotoxicity testing methods."BioReliance will present a scientific poster detailing the Big Blue TRM qualification studies at the upcoming EUROTOX Conference ( Sept. 1-4, 2013, Interlaken, Switzerland). Big Blue TRM experts will be available for individual consultation at this event and at the Environmental Mutagenesis and Genomics Society Conference ( Sept. 21-25, 2013, Monterey, Calif., U.S.). To read about the exclusive license of Big Blue earlier this year, click here. For more information on the Big Blue Mouse TRM assay service, click here. The foregoing release contains forward-looking statements that can be identified by terminology such as "will be," "anticipates," "believes" or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived therefrom. You should not place undue reliance on these statements. There can be no guarantee that the products and services in SAFC's product and service offerings will continue to meet the demands of the marketplace. Nor can there be any guarantee that any of these products or services 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 and services 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, trademark 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 U.S. 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. About BioReliance by SAFC: Sigma-Aldrich Corporation acquired BioReliance in January 2012 to provide customers' access to a powerful, single-point provider whose products and services span the drug discovery, development and commercialization pipeline. As part of the SAFC business unit, BioReliance is a leading provider of cost-effective contract services, offering more than 1,000 tests or services related to biologics safety testing, specialized toxicology and animal health services. BioReliance has more than 700 employees and has laboratory operations in Rockville, Md. and Scotland. For more information, visit www.bioreliance.com . About SAFC: SAFC Commercial, the custom manufacturing and services business unit of Sigma-Aldrich Corporation, is recognized as a top 10 global specialty chemicals and biologics supplier. As a trusted manufacturer for the life sciences and high-technology industries, SAFC works closely with customers to resolve development challenges and accelerate the product pipeline utilizing its global "Centers of Excellence" and dedicated manufacturing facilities. Its rich portfolio includes high-purity inorganic materials for high-technology applications, critical raw materials and extensive biologics safety testing services for biopharmaceutical manufacturing, and complex, high-potent APIs and key intermediates for pharmaceutical manufacturing. For more information, visit www.sigmaaldrich.com/safc . About Sigma-Aldrich : Sigma-Aldrich, a leading life sciences and high-technology company focused on enhancing human health and safety, manufactures and distributes more than 200,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets. With three distinct business units—Research, Applied and SAFC Commercial—Sigma-Aldrich is committed to enabling science to improve the quality of life. The company operates in 38 countries, has more than 9,000 employees worldwide and had sales of $2.6 billion in 2012. For more information about Sigma-Aldrich, please visit its website at www.sigma- aldrich.com . ©2013 Sigma-Aldrich Co. LLC. All rights reserved. SAFC is a trademark of Sigma-Aldrich Co. LLC or its affiliates, registered in the U.S. and other countries.