BioReliance, Sigma-Aldrich Corporation’s biologics and early-development services business under SAFC Commercial, announced 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 focussed on standardising 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 per cent across specific assays to enhance their statistical power, and we continue to optimise 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 recognise 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.