Although regulatory genetic toxicology testing has been around for nearly 30 years, interpretation of the reliability of negative results and of the relevance of positive results continues to pose problems. The occurrence of positive results from in vitro tests, particularly in mammalian cells, that do not predict in vivo genotoxic or carcinogenic activity, is uncomfortably high. The frequency of “misleading” positive results ranges from 25-40% depending on the database used. The process of interpreting whether a positive result will inhibit the development of a new substance (perhaps rejection of a clinical trial application, or delays in regulatory acceptance) is not simple and requires expert evaluation.

In order to help clients make the best decisions, the services available can be summarised as follows:
Literature reviews
Criticial review of data
Recommendations on study design and conduct
Monitoring of genotoxicity studies at contract facilities
Expert advice and problem solving
Preparation of expert commentaries/”white” papers
To accompany regulatory submissions
To defend a regulatory position
For potential out-licensing
In respect of potential in-licensing
Preparation of strategy or position papers
Advocacy at meetings with regulatory agencies
Advice on go/no go decisions