Aiming at best supporting our customers' pharmaceutical projects, experts from Creative Biolabs proudly introduce our integrated gene toxicity testing service to our global clients.

Many chemical compounds might exert genotoxic effect through interactions with cellular DNA, and potentially be human carcinogens and/or mutagens which eventually lead to cancer or other heritable defects. Therefore, genotoxicity profile has evolved as a standard regulatory request prior to new drug approval. Genotoxicity assays are designed to detect certain components with possible risk of inducing genetic damages directly or indirectly by various mechanisms. It can help to eliminate potential genotoxic hazard during the early development stage and discern the risks of heritable mutations, developmental defects, tumorigenesis and other long-term adverse genetic impacts.

Creative Biolabs offers a full range of gene toxicity liability assessment services based on extensive experience and world-class technologies. We can conduct multiple in vivo and in vitro assays under both non-GLP and GLP (OECD-compliant) conditions.

Gene Toxicity

In Vitro Assays

  • Mutation tests in bacteria and mammalian cell lines

Ames test is a bacterial reverse mutation assessment using Salmonella typhimurim and E. coli mutant strains with histidine/tryptophan defects. Test compounds capable of introducing back mutations can result in viable strains growing in the certain culture medium. Ames test is one of the most recognized genotoxicity assays and widely employed as an initial screen to determine mutagenic potential of new drugs. There are a variety of bacteria strains available in Creative Biolabs for detecting diverse mutation modes (such as frameshift, base substitution), from which you can select suitable options depending on different objectives.

Furthermore, we also provide mouse lymphoma assay (MLA) for detecting forward gene mutations in eukaryotic cells as the complement of Ames test.

  • Chromosome aberration

In vitro mammalian chromosomal aberration test is utilized to identify chromosomal structure aberrations and clastogenicity following short- or long-term exposure to test compounds in human lymphocytes or Chinese hamster ovary cell lines. Additionally, scientists in Creative Biolabs are also able to monitor genotoxicity-related DNA double-strand breaks (DSBs) using γH2A.X (Ser-139), a highly specific and sensitive molecular marker for DNA damages.

  • Micronucleus assay

If a chromosome of a chromosomal fragment is wrongly incorporated due to genetic damage, it may form one “micronucleus”. Hence, in vitro micronucleus assay (MNvit) emerges as a mutagenic test platform for discovering substances that cause the formation of these small membrane-bound DNA fragments (micronucleus) in CHO-K1 cell lines. This assay enables accurate detection of both clastogen and aneugens, and sensitive prediction of genotoxic potential. Notably, in a combination of high content screening (HCS) and fluorescent cellular imaging, MNvit can synchronously collect multiple endpoints with enhanced throughput, objective automatic scoring and rapid measurement of a large panel of cells. By efficiently delivering multi-parametric outcomes, this assay provides a more mechanistic insight into genotoxicity.

In Vivo Assays

Creative Biolabs has prepared series of in vivo tests constituting further supplement for in vitro assays. We offer comprehensive tests for rodent bone marrow micronucleus and chromosome aberrations. In addition, Comet assay and combination of Comet and micronucleus are also excellent choices for rapid and sensitive DNA alteration assessment.

In terms of the state-of-the-art platform, Creative Biolabs is specialized in conducting high-quality genetic toxicity studies in a tiered approach, starting with Ames assays and progressing to mammalian cells and in vivo assessment, ensuring efficient detection of genotoxic hazard within early stages. Furthermore, our service is highly flexible and customized with different cell lines, endpoints, and time points to satisfy specific objectives. Our experienced scientific team will be working closely with you to deliver regulatory-compliant reports based on the most up-to-date guidelines for best facilitating your drug discovery projects.

For more detailed information, please feel free to contact us or directly sent us an inquiry.

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