Genotoxicity Testing

Bacterial reverse mutation test (Ames test)

At Vivotecnia we perform the Ames Test (OECD TG 471) as part of our standardized battery of genotoxicity studies, key for the preclinical evaluation of new compounds in regulated industries. This in vitro test allows detecting the mutagenic capacity of chemical substances through the use of modified strains of Salmonella typhimurium and Escherichia coli.

Preclinical regulatory CRO

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Established – 2000

A key trial in regulatory studies

The Ames Test is mandatory for the approval of drugs, industrial chemicals, cosmetic ingredients and food additives. Its inclusion in the registration dossier is required by agencies such as the EMA, FDA and OECD, and is part of the ICH S2(R1) guidelines for drug development. 

What we offer at Vivotecnia

GLP-certified studies since 2003

OECD and ICH compliant

Performed with and without S9 activation

QA-audited, submission-ready reports

Industries we support

Pharmaceutical
Pharmaceutical
Chemical 

Chemical 

Cosmetics 

Cosmetics

Food & Nutrition 
Food & Nutrition 

Infrastructure and equipment

Vivotecnia has a highly specialized bioanalytical unit that combines state-of-the-art technology with a multidisciplinary team of experts in regulated preclinical studies. 

Infrastructure and equipment

WHY VIVOTECNIA

High-performance equipment

High-performance equipment

SCIEX Triple Quad™ LC-MS/MS, UPLC, HPLC, NanoLC 400 and robotic automation systems for sample handling.  
Comprehensive digital management

Comprehensive digital management

Provantis® platform for document control, traceability and regulatory compliance.

Expert team

Expert team

Professionals with experience in more than 4,000 preclinical studies, including mutagenicity, toxicity and pharmacokinetics.
Excellence in quality and compliance 

Quality assurance

All assays are performed under GLP certification and are audited by our internal Quality Assurance unit.

Do you need to perform an Ames Test as
part of your regulatory dossier?

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