Regulatory Strategies
and Safety
Genotoxicity Testing

Compounds testing positive in genotoxicity studies are potential carcinogens and/or mutagens in humans. TriApex can perform scientific, accurate and rapid genotoxicity testing of compounds, and set out scientific follow-up test strategies for compounds at risk.

Service Advantages

1. TriApex is staffed with professional and experienced genotoxicity study directors and technicians. We can conduct rapid and reliable early mutagenicity screening of compounds, and a standard battery of genotoxicity tests in compliance with GLP regulations.

2. TriApex can provide customized study design and additional tests as appropriate based on proposed indications and compound characteristics.

3. TriApex can provide the advices from the perspective of regulatory agent, to support the IND and NDA application to regulatory authorities including NMPA, FDA, and OECD.

Service Capacities

Screening Assays:



In Vitro Assays:

Bacterial Reverse Mutation Assay (Ames)

CHL Cell Chromosome Aberration Assay

Mouse Lymphoma Tk Gene Mutation Assay

In Vivo Assays:

Micronucleus Assay in Rodents

Alkaline Comet Assay in Rodents

Combined/Integrated Alkaline Comet/Micronucleus Assay


Genotoxicity tests are mainly used for the prediction of carcinogenicity, and also used for evaluating mutagenic impurities in pharmaceuticals to limit potential carcinogenic risk. Genotoxicity tests are used for rapid screening of compounds in early drug development to lower R&D risk.

TriApex can conduct genotoxicity tests to support early development and IND filing, mainly including:

-In the early stages of drug development: Bacterial reverse mutation (Ames) assay is widely used in the drug discovery and have proven to be the most predictive in vitro test for carcinogenicity in rodents and humans. Mini-Ames test can help to solve the problem of difficult synthesis or extract in large quantities.

-TriApex usually uses a standard test battery in the nonclinical safety study:
Option 1: In vitro bacterial reverse mutation assay (Ames), in vitro chromosome aberration assay or mouse lymphoma Tk gene mutation assay, and in vivo genotoxicity study.

Option 2: In vitro bacterial reverse mutation assay (Ames), in vivo assessment of genotoxicity study with two different tissues. 

Project Experience

TriApex has completed more than 200 genotoxicity tests. 

In the case of one candidate not intended to be developed in oncology, we conducted 3 standard genotoxicity tests (bacterial reverse mutation (Ames) assay, in vitro chromosome aberration assay and in vivo micronucleus assay) of one non-antitumor drug to support the IND application. The in vitro chromosome aberration assay was evaluated as equivalent positive result, then alkaline comet assay in rats was conducted as the follow-up test (the result was negative), which increased the reliability of the results to assist sponsors in IND approval.