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Comet Assay News

Wednesday, June 2007

ICH Announces Revision to Guidelines for Genotoxicity Testing to Include the Comet Assay

To enhance the ability of current testing procedures to detect tissue specific genotoxins, the International Conference on Harmonization (ICH)Steering Committee met in May 2007 and included the comet assay in their Revision to the 1997 Guidelines for Genotoxoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. More information about ICH Guidelines and the most recent revisions can be found at the ICH website

News Item posted by Helix3 at 10:22 am

Monday, January 2007

REACH: EU legislation Requires Additional Chemical Safety Testing

As of 1 June 2007, REACH regulation (Registration, Evaluation, Authorisation and Restricition of Chemicals)will require over a period of 11 years the re-testing and registration of some 30,000 chemical substances in use today, a process which will allow regulatory agencies to fill information gaps on the hazards of substances and to identify appropriate risk management measures to ensure their safe use. As one of the few methodologies capable of measuring DNA damage in any eukaryotic cell type, the Comet Assay will play an imporant role in the new risk assessment of these chemicals. More information about REACH can be found at the Europa European Commission website

News Item posted by Helix3 at 9:30 pm

IWGT Comet Assay Working Group Meeting at 9th Annual ICEM, San Francisco Sept 2006 (publication citation listed below)

Joint Committees on Mutagenicity (COM) and Carcinogenicity (COC) of Chemicals in Food, Consumer Products, and the Environment recognize the Comet Assay as a well established supplementary assay to standard battery of genetox tests Oct 2005. Link>>

Previous News

Important Publications

Helix3 Poster Presentations:

Safety Testing With the In Vitro Comet Assay: Critical Factors in Protocol Design and Data Interpretation.

Cytotoxicity and its Impact on the In Vivo Comet Assay.

Effects of Sample Processing on the Interpretation of In Vivo Comet Assay Data

Technical Documents:

Low Molecular Weight (LMW) DNA Diffusion Assay

CFDA/EtBr Dual Stain Viability Assay

Regulatory Guidelines:

4th International Workgroup on Genotoxicity Testing: Results of the In Vivo Comet Assay Workgroup. Published: Mutation Research 2007 Feb 3; 627(1): 31-5.

FDA Recommendations for the Integration of Genetic Toxicology Study Results (2006)

COM Guidance for Chemical Mutagenicity Testing (2000)

ICH Guidelines for Standard Battery of Genotoxicity Testing (1997)