Transgenic Mouse Model Validated for Carcinogenicity Studies
October 1, 2009 – Charles River is pleased to offer the rasH2 transgenic mouse model as a recently validated alternative to traditional two-year carcinogenic bioassays. Transgenic mouse oncogenicity models such as the Tg.Ac, p53 and rasH2 models offer a range of benefits, including shorter study durations, lower study costs and quicker report times. The rasH2 model is more widely applicable than the Tg.AC and p53 models and is becoming the preferred transgenic mouse alternative for most major regulatory bodies.
With the rasH2 assay, sponsors can save valuable time and resources by dramatically shortening the duration of their carcinogen studies from the usual two years to a mere six months. Despite the cost of the transgenic mice, the overall study cost of a six-month rasH2 study is considerably less than that of a traditional two-year mouse carcinogenicity study.
In addition, sponsors can take advantage of the much quicker report turnaround time with the rasH2. Reporting for a two-year study takes a minimum of six months and often takes longer. With the rasH2 model, report turnaround time is 20 weeks or less.
The rasH2 model is appropriate for the testing of both genotoxic and non-genotoxic compounds, and is accepted as an alternative to two-year mouse carcinogenicity studies by the U.S. Food and Drug Administration, the Japanese Ministry of Health, Labor, and Welfare and the EMEA for regulatory submission.
With all these benefits, the rasH2 transgenic mouse model could be an ideal choice for your carcinogen studies. Please contact us at 1.877.CRIVER.1 (1.877.274.8371) or askcharlesriver@crl.com for more information.