BioReliance Implements Newly Adopted OECD Guidelines for Genetic Toxicology Testing After Participating in Regulatory Working Groups

November 6, 2014 – Media Alert

BioReliance® (www.bioreliance.com), Sigma-Aldrich Corporation’s (NASDAQ: SIAL) biologics and early-development services business under SAFC® Commercial (www.sigmaaldrich.com/safc), announced today that its full genetic toxicology assay portfolio meets newly ratified universal Organisation for Economic Cooperation and Development (OECD) Guidelines. Scientists from BioReliance were invited to participate in the global OECD expert working groups responsible for updating the guidelines, which were adopted on September 26, 2014, and have worked internally to ensure assays meet the new requirements, including statistical accuracy of negative and positive test results. Customers can benefit from seamless access to the revised guidelines, eliminating any delays that could result as companies seek to comply with the new requirements.

“In response to the updated guidelines, we have been focused on standardizing study design and analysis through improved power,” said Scott Hickman, Market Segment Manager for Toxicology at BioReliance. “We have increased the number of cells scored in manual evaluation by as much as 100% across specific assays to enhance their statistical power, and we continue to optimize our processes for automated analysis.”

Since early 2012, expert groups have been working together to achieve clarification related to the update of the test guidelines and the Mutual Acceptance of Data (MAD) agreement. BioReliance scientists took part in these working groups to help define data-driven changes, to upgrade assay design and to interpret results. These efforts resulted in revised test guidelines for the following:   

  • TG 473: In Vitro Mammalian Chromosomal Aberration Test
  • TG 487: In Vitro Mammalian Cell Micronucleus Test
  • TG 474: In Vivo Mammalian Erythrocyte Micronucleus Test
  • TG 475: In Vivo Mammalian Bone Marrow Chromosomal Aberration Test

In addition, a new test guideline was also introduced to measure DNA strand breakage:

  • TG 489: In Vivo Mammalian Alkaline Comet Assay

While studies using the new guidelines can be initiated immediately, genetic toxicology testing service providers and their customers have a transitional period of 18 months during which they can initiate studies using either the old guidelines or the newly revised guidelines.  

“As members of these working groups, our team of scientists felt a responsibility to comply early on, as they recognize the increased power of these enhanced study designs,” said Tim Lawlor, Director of Genetic Toxicology. “We have been diligently working to adjust our laboratory procedures to accommodate the new designs and implement them as the new standard at BioReliance.”

The updated BioReliance assays are available immediately. To learn more about BioReliance’s full portfolio of genetic toxicology testing services, visit: www.bioreliance.com, or click the following links to learn more about the Comet Assay, or access the Series of Testing and Assessment report.


About BioReliance by SAFC: As part of the Sigma-Aldrich Corporation, operating under the SAFC Commercial business unit, BioReliance is a key component of the company's commercial life science services portfolio. With locations worldwide, BioReliance offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. 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 science and high-technology industries, SAFC works closely with customers to resolve development challenges and accelerate the product pipeline using 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.sigma-aldrich.com/safc.

About Sigma-Aldrich: Sigma-Aldrich, a leading life science and high-technology company focused on enhancing human health and safety, manufactures and distributes 230,000 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 37 countries, has more than 9,000 employees worldwide and had sales of $2.7 billion in 2013. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.

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