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The Syrian Hamster Embryo (SHE) assay is a short-term in vitro test designed to assess a substance's carcinogenic potential based upon its ability to cause morphologic transformation of SHE cells. Under the strategy for testing the carcinogenic potential of a pharmaceutical, the ICH Harmonised Tripartite Guideline S1B indicated that data from cell transformation assays can be useful at compound selection stage 2 and eliminate the need for costly and time consuming in vivo testing before entering human clinical trials. Results from the SHE assay are reported to correlate well with rodent carcinogenicity testing.

The SHE assay provides a means to investigate a positive genotoxic result quickly and cost effectively. A positive result at the screening stage once meant that an investigator would have to perform a standard in vivo carcinogenicity study that could take up to 3 years. The SHE assay offers an alternative, regulatory approved, means to check the validity of the positive result before embarking on potentially unnecessary and expensive research.

BioReliance's SHE assay is the latest in a series of expansions designed to enhance the range of services available to clients interested in genetic toxicology testing.


Syrian Hamster Embryo (SHE) Cell Transformation Assay

Normal SHE cells

Transformed SHE cells