Genetic Toxicology Services

Fully Compliant with US FDA, OECD, Chinese SFDA GLP Requirements

The Genetic Toxicology laboratory at WuXi AppTec provides GLP genotoxicity assays in support of regulatory filing. Emphasis is placed on producing high quality results and reports while significantly minimizing costs and the timeframe required whenever there are tight schedules to meet. Non-GLP versions of these assays can also be applied to meet specific client requirements for safety lead optimization.

Our experienced staff and state-of-the-art facility provides rapid, reliable assessment of the mutagenic, clastogenic potential of new chemical entities. Screening of entities can often be conducted with the Mini-Ames and In Vitro micronucleus tests helping detect potential liabilities early and reducing later stage attrition.

WuXi AppTec provides a range of validated standard assays and appropriate battery of tests to meet international regulatory requirements for pharmaceutical, chemicals and agro-chemicals.

WuXi's Genetic Toxicology Service Offering Includes:

Screening Assays

  • Mini-Ames
  • Microwell micronucleus assays

Standard Assays

  • In Vitro
    • Ames assay
    • In Vitro Chromosome Aberration assay in CHO-WBL Cells or Human Lymphocytes
    • Mouse Lymphoma assay in L5178Y Cells
    • In Vitro Chromosome Aberration Assay
    • In Vitro Micronucleus assay in CHO-WBL Cells
  • In Vivo
    • Rodent (Rat or Mouse) Bone Marrow Micronucleus assay
    • Integration into standard toxicology studies
  • Other
    • Advice on regulatory requirements and testing strategy
    • GLP and analytical chemistry support