Registration of pharmaceuticals requires a comprehensive assessment of their genotoxic potential. This assessment is performed according to advice on the timing of the studies relative to clinical development provided in the ICH guidance M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH  M3(R2) guidance). According to this guideline, prior to first human exposure, in vitro tests for the evaluation of mutations and chromosome damage are required. If an equivocal or positive finding occurs, additional testing should be performed. The standard battery of tests for genotoxicity (ICH Topic S2) should be completed prior to the initiation of Phase II studies

Besides ICHM3, guideline ICH S2(R1) provides guidance to drug sponsors on which tests should be performed to assess potential genotoxicity of pharmaceuticals throughout the preclinical development of new pharmaceuticals.Vivotecnia provides a full genotoxicity testing service in compliance to these guidelines, including  advice on testing conditions, data interpretation, and followup strategies if a positive response is seen in in vitro assay. These services ensure that your compound is appropriately tested for potential to cause genetic damage in compliance with regulatory requirements.

Genotoxicity testing of pharmaceuticals


Testing battery Option 1:

  • A test for gene mutation in bacteria.
  • A cytogenetic test for chromosomal damage (the in vitro metaphase chromosome aberration test or in vitro micronucleus test), or an in vitro mouse lymphoma tk gene mutation assay.
  • An in vivo test for genotoxicity, generally a test for chromosomal damage using rodent hematopoietic cells, either for micronuclei or for chromosomal aberrations in metaphase cells. Can be integrated into repeat tox studies if suitable dose used

Testing battery Option 2:

  • A test for gene mutation in bacteria.
  • An in vivo assessment of genotoxicity with two different tissues, usually an assay for micronuclei using rodent hematopoietic cells and a second in vivo assay. Typically this would be a DNA strand breakage assay in liver, unless otherwise justified. Can be integrated into repeat tox studies if suitable dose used.
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  • Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Atuthorization
    for Pharmaceuticals M3 (R2).
  • Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. ICH
    S2 (R1).
  • ICH M7: Assessment and control of DNA reactive (Mutagenic) Impurities in Pharmaceuticals to Limit potential
    carcinogenic risk.
Our team and Experience

Vivotecnia provides services and solutions to help pharmaceutical, chemical, cosmetics and other industries
to optimise the development of their compounds by testing genotoxicity through our testing packages
complying regulatory guidelines and GLP standards.
You can rely on the vast experience of our team of scientist, which have conducted hundred of assays, to
conduct an accurate and reliable genetic toxicology assessment of your compound. Vivotecnia can provide
assays and advice on follow-up strategies for mechanism elucidation (involving clastogenicity, aneugenicity
and DNA effects such as frameshift, transverse and transition mutations).

Our team will discuss with you the specific needs of your project providing detailed assay documentation and
data reporting in compliance with our internal Standard Operating Procedure protocols.

The staff is fully trained, which allow us to offer a very efficient and cost-effective service. Moreover, our team of experts is trained to troubleshoot all the issues on genotoxicity testing, and can advise you on assay design and performance to yield the best data for your compound.


genotoxicity services

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