Genotoxicity and Mutagenicity 

Genotoxicity and mutagenicity analyses have a significant role in the identification of hazard effects of therapeutic drugs, cosmetics, agrochemicals, industrial compounds, food additives, natural toxins and nanomaterials for regulatory purposes. To evaluate mutagenicity or genotoxicity, MB Biosciences offers in vitro, non-GLP gene-tox services as recommended by regulatory agencies. Our Mini Ames test assay is regulatory-approved and can identify compounds that are potential mutagens and is designed for screening large numbers of compounds in a high-throughput 384-well format. For compounds that induce chromosome damage, MB Biosciences offers in vitro micronucleus screening and In Vitro Chromosomal Aberration Assay. We also offer In Vitro Mammalian Cell Gene Mutation Test (HPRT Gene), Mouse Lymphoma Thymidine Kinase (TK) Gene Mutation Assay in a 96-well plate format and In Vitro Comet Test, providing both objective and consistent data.

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Key Features of Our Genotoxicity Tests

  • Reproducible and Consistent data

  • Rapid turnaround time (10 business days)

  • Best price guarantee

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage. Determination of a compound’s potential genotoxicity is an important component of a complete safety assessment of all new products. By identifying genotoxicity at an early stage in drug discovery rather than during regulatory assessment, the likelihood of late stage failures is reduced.

Genotoxicity studies include tests that detect gene mutations, structural and numerical chromosomal aberrations and abnormalities, as well as tests that evaluate induced DNA damages resulted from DNA strand breaks and DNA adducts.

MB Biosciences offers a series of genotoxicity tests to identify chemicals that can cause genetic alterations in cells following the OECD test guidelines, including bacterial reverse mutation test OECD 471 (Ames test), in vitro mammalian chromosomal aberration test OECD 473, in vitro mammalian cell micronucleus test OECD 487, in vitro gene mutation assays OECD 490, and  in vitro comet assay.  Biosciences offer a variety of in vitro genotoxicity tests, including but not limited to:

•Ames MPF (Mini Ames) and Bacterial Mutation Test (Ames, OECD 471)
Commonly known as Ames test, the bacterial reverse mutation test identifies chemicals that induce point mutations using Salmonella typhimurium and Escherichia coli that contain identified mutations in specific amino acid biosynthesis gene. Chemicals that can induce point mutations may induce a reverse mutation that enables the bacteria to grow on medium that lacks the required amino acid. MB Biosciences offer both Ames MPF test and Ames OECD471 test which determine the mutagenesis using two strains TA98 and TA100 or using 5 bacterial strains including TA98, TA100, TA1535, TA1537, and WP2 uvrA respectively.  

•Ames II
Mini Ames MPFTM 98/Mix assay allows a significant reduction of the quantity of test substance needed (50 mg) but remains applicable to the Salmonella strains used in regulatory protocol. High sensitivity and excellent correlation with agar plate test. High throughput, automatable for large numbers of compounds screening.

•Mammalian Chromosome Aberration Test (OECD 473)
The chromosomal aberration test is used to identify chemicals that cause structural chromosomal aberrations using cultured mammalian peripheral blood lymphocytes or established mammalian cell lines, for example Chinese Hamster Ovary cell line (CHO). In this test, individual cells are examined under microscope for chromosomal aberrations following the exposure of test chemicals.

•Mammalian Cell Micronucleus Test (OECD 487)
The in vitro micronucleus test, as chromosomal aberration test, can be conducted on cultured mammalian peripheral blood lymphocytes or established cell lines including CHO. It is used to identify chemicals that cause chromosomal breaks and aneuploidy.

•Mammalian Cell Gene Mutation Test (TK Gene, OECD 490)
The gene mutation assays, using specific thymidine kinase (tk) heterozygous cell lines, are used to identify chemicals that cause gene mutations at the tk reporter locus. The chemical induced gene mutation can be evaluated by observing the size and appearing time of colonies and enumerating their frequencies.

•Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476)
The in vitro mammalian cell gene mutation test is used to detect mutations of the hypoxanthine-guanine phosphoribosyltransferase (HPRT) gene in Chinese hamster ovary (CHO) or lung (V79) fibroblasts.

•In vitro comet assay
In vitro comet test, also known as single-cell gel electrophoresis (SCEG) test, is a sensitive method for rapid detection of DNA damage in single cells, including double-strand breaks, single-strand breaks, and alkali labile sites. The comet assay detects the migration of DNA in an agarose gel following electrophoresis, which results in a “head” of intact DNA and a "tail" of fragmented DNA. The percentage of DNA in the tail of the comet is used as a measure of DNA damage.

MB Biosciences have deep knowledge and experience in toxicological research and compound safety evaluation throughout the years. We perform in vitro genotoxicity assays and consulting.. If you have any special needs or questions regarding our services, please feel free to contact us at info@mbbiosciences.com or 617-952-3848 to get support from our experienced experts. We look forward to working with you in the near future.