ST LOUIS, Mo., March 5, 2013 /PRNewswire/ -- Sigma-Aldrich ® Corporation (NASDAQ: SIAL) today announced that BioReliance ® ( http://www.bioreliance.com), the biologics and early development services business under SAFC ® ( www.safcglobal.com), has signed an agreement to acquire the colonies required for the Big Blue® transgenic rodent mutation (TRM) assay and to obtain a license to its associated trademark from Agilent Technologies.
TRM assays, which measure mutation frequency in any tissue, are the first in vivo genetic toxicology mutation assays to be approved by the Organization for Economic Co-Operation and Development (OECD), meeting Testing Guideline 488. BioReliance is now the owner of Big Blue ®, mutation models and the exclusive supplier of testing services based on this model.
"It is often of critical importance to use an in vivo mutation assay in order to assess human risk in drug development and chemical manufacturing. Big Blue ® is such an assay and one we are intimately familiar with, having been part of the initial co-development team in the 1990s," stated Daniel Aparicio, Executive Director and General Manager of Early Development Services at BioReliance. "Based on feedback from our customers and from the market in general, we believe there will be an ever-increasing demand for transgenic rodent assays and we are delighted to be able to bring that capability to customers on the back of this agreement."
BioReliance is now focused on completing the transfer of colonies and cell lines from Agilent and building full capacity and capability to perform the Big Blue ® assay. BioReliance is in the process of re-qualifying the assay to meet new regulatory requirements and anticipates that Big Blue ® testing services will be commercially available in the second half of the year.BioReliance has been a leading provider of genetic toxicology testing services over the past two decades and continues to innovate and offer the latest technologies to help ensure the safety of pharmaceuticals and chemical compounds. The Big Blue ® Testing Assay was originally validated by BioReliance to use as a GLP regulatory submission assay to detect chromosomal and/or gene mutations in collaboration with Agilent in the early 90s. To learn more about BioReliance by SAFC, please visit: www.bioreliance.com The foregoing release contains forward-looking statements that can be identified by terminology such as "will be," "anticipates", "believe" 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 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 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. About BioReliance by SAFC: BioReliance was acquired by Sigma-Aldrich Corporation, in January, 2012 to supply 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 over 700 employees and has laboratory operations in Rockville, MD and Scotland. For more information, visit www.bioreliance.com . About SAFC: SAFC , 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 science 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.safcglobal.com . About Sigma-Aldrich : Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology SAFC manufacturing. Sigma- Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma- Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com . ©2013 Sigma-Aldrich Co. LLC. All rights reserved. BioReliance and SAFC are trademarks of Sigma-Aldrich Co. LLC or its Affiliates, registered in the US and other countries.