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Gentronix will be showcasing its latest product and service developments at the Society of Toxicology 49th Annual Meeting and ToxExpo at booth 1919 to be held in Salt Lake City. New research using 75 marketed pharmaceuticals shows GreenScreen HC from Gentronix is more predictive for genotoxic carcinogenicity than existing regulatory in vitro assays.
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Manchester, UK - 11 February 2010 - Gentronix will be showcasing its latest product and service developments at the Society of Toxicology 49th Annual Meeting and ToxExpo at booth 1919 to be held in Salt Lake City. New research using 75 marketed pharmaceuticals shows GreenScreen HC from Gentronix is more predictive for genotoxic carcinogenicity than existing regulatory in vitro assays.
Published in Mutagenesis, the analysis provides additional evidence to support the use of the Gentronix assay in the early identification of genotoxic liability or in non-clinical safety assessment of candidate pharmaceuticals during development. As well as more accurate prediction of in vivo genotoxicity (88%) and genotoxic carcinogenicity (93%) than other in vitro genotoxicity tests, the assay maintained its high specificity: no new genotoxicity and/or carcinogenicity alerts were produced for any of the compounds tested.
All marketed pharmaceuticals have other published regulatory in vitro and in vivo genotoxicity data, and often carcinogenicity study data. These allow accurate calculation of predictive statistical data. The accumulated data from carcinogenicity and regulatory genotoxicity studies to date, including this new study, shows the overall specificity and sensitivity of GreenScreen HC for genotoxic carcinogenicity to be 95% and 87.5% respectively.
Data from this human cell-based assay has application in 'weight of evidence' approaches when assessing the biological relevance of positive in vitro mammalian cell assay data, where no bacterial mutagenicity has been observed, prior to conducting in vivo testing. With the high throughput, low resource and compound requirement of GreenScreen HC, data can be generated at an earlier stage of the drug development process. This additionally allows prioritization of compounds to be progressed for non-clinical studies to support clinical investigations.
ENDS
Editor's note
About Gentronix Ltd.:
Gentronix provides services and solutions for a wide range of chemistry-driven industries that help reduce attrition rates and ensure safer products. Gentronix' primary focus is on providing better hazard identification assays for genotoxicity through its GreenScreen® and BlueScreen™ human cell assay technology. All Gentronix assays are designed for use much earlier in drug and compound discovery than the standard battery of genotoxicity tests, and provide positive results that are more accurately predictive of in vivo risk than the current in vitro mammalian assays. In addition, the high specificity of the assays means that valuable compounds are not discarded due to false positive toxicology.
For further information, please contact: Steve Beasley, Commercial Director, Gentronix Limited, CTF Building, 46 Grafton Street, Manchester, M13 9NT UK.
Tel: +44 (0)161 603 7676
Email: steve.beasley@gentronix.co.uk
Website: www.gentronix.co.uk
For further press information, please contact: Catherine Butcher, or Nicola Aldren, Barrett Dixon Bell, Craig Court, 25 Hale Road, Altrincham, Cheshire WA14 2EY UK.
Tel: +44 (0)161 925 4700 Fax: +44 (0)161 925 4701
Email: catherine@bdb.co.uk, nicola@bdb.co.uk
Contact Information
Nicola Aldren
Gentronix Limited
CTF Building
46 Grafton Street
Manchester
M13 9NT
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