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TEST REQUEST

Corporate studying toxicology for health and happiness of human.

Testing field

Genetic toxicology exam observes a phenomenon which examination substance damages DNA or chromosome and causing morphological change or functional abnormality.

Genetic toxicology is a significant test item conducted at the screening level of development of new medicine or chemicals, and plays significant role for deciding the development.

Genogen Co.,Ltd conducts genetic toxicology test as condition for various guideline and conducts counseling for the test.

As for the types of genetic toxicology exam, there are various methods for verification of diverse toxicity, and the most general method is 3 batteries which are bacterial reverse mutation test, in vitro chromosomal aberration test, in vivo micronucleus test.

  • Bacterial Reverse Mutation Test

    Reverse mutation is a test checking genetic toxicology by confirming the conversion of strains with deterred amino acid synthesis to amino acid synthesis strain by causing mutation from test chemical. The test method examines hereditary damage of DNA using more than 5 strains. It shows very close of correlation with the result of carcinogenicity test which is simple and rapid among other test methods. It is widely used to safety test of early screening level and medicine, food additive, agricultural pesticide, normal chemicals of new medicine development.

  • In vitro vitroChromosomal Aberration Test

    As the method to measure the structural abnormality of chromosome, In vitro chromosomal aberration test generally use Chinese Hamster Lung(CHL), Chinese Hamster Ovary(CHO) cell which is mammal cell.

  • In vitro gene mutation test/Mouse Lymphoma TK assay

    Mouse Lymphoma TK assay test measure thymidine kinase gene mutation by test chemical, which generally use L5178Y tk +/- Mouse Lymphoma Cell.

  • In vivo Micronucleus Test

    In vivo Micronucleus test is used to detect abnormal chromosome caused in bone marrow cell or peripheral blood cell and measure the formation of micro-nucleus including the piece or whole chromosome.

  • Provided service items

    Reverse mutation screening test
    Biological evaluation of medical devices - Test chemicals elution and reverse mutation test (ISO 10993 series)

Due to the increase of interest toward hygiene, sanitary and stability based on improvement of living standard, many antibacterial products are in development. Antibacterial means resisting germs from growing, and antibacterial agent is used to kill germs by adding to raw material, ingredient and products. As for the verification test for antibacterial materials, we conduct MIC test, MBC test and Agar diffusion assay. MIC test is able to confirm the minimal concentration resisting growth of germ. and MBC test is able to confirm the sterilization concentration of 99.9%.

  • Provided service items

    MIC (Minimum Inhibitory Concentration) test
    MBC (Minimum Bactericidal Concentration) test
    Agar diffusion assay, Paper Disk Method

Cytotoxicity and genetic toxicology test for biological safety test of medical devices

Common criteria standard regarding biological safety of medical appliances (KFDA announcement no. 2014-115)
International Test Standard ISO 10993 Biological evaluation of medical devices

  • Provided service items

    MTT assay
    XTT assay