Mouse Lymphoma TK Assay (MLA)
The Mouse Lymphoma TK Assay (MLA) is used to detect a spectrum of genetic events denoting gene mutations induced by chemical substances in the cell lines that measure mutation at thymidine kinase (TK).
- Purpose: Detects mutations in the thymidine kinase (TK) gene in L5178Y mouse lymphoma cells
- Applications: Screening, IND-Enabling studies, ICH S2(R1) standard battery, REACH requirement, Annex VIII testing
- Procedure: Cells are exposed to test compounds, subcultures, and selected for mutants using trifluoro thymidine (TFT)
- Positive Outcome: Dose-dependent increase in mutant frequency exceeding the Global Evaluation Factor (GEF)
Our genetic toxicologists can help you design a battery of tests that produce high-quality data, so you can be aware of the potential risks during subsequent development stages. This allows you to:
- Identify and mitigate potential genotoxic risks early in the development process
- Reduce the likelihood of regulatory delays or setbacks
- Protect the health of consumers and patients
- Make informed decisions about the development and commercialization of your product
When to perform MLA TK Assay?
- Screening
- IND-Enabling Studies
- As part of the ICH S2(R1) standard battery
- REACH requirement
- As part of Annex VIII testing
- Other uses
- To assess mutagenicity when the Ames assay may not be appropriate (e.g., antibiotics, nanomaterials)
HPRT Gene Mutation Assay
The in vitro mammalian cell gene mutation test is used to detect mutations of the hypoxanthine-guanine phosphoribosyl transferase (HPRT) gene in L5178Y mouse lymphoma cells, Chinese hamster ovary (CHO), or lung (V79) fibroblasts.
- Purpose: Detects mutations in the hypoxanthine-guanine phosphoribosyl transferase (HPRT) gene in L5178Y mouse lymphoma cells, Chinese hamster ovary (CHO), or lung (V79) fibroblasts
- Applications: Screening, reduced volume or abbreviated formats, REACH requirement, Annex VIII testing, confirmation of presumed mutagenic activity from other assays
- Procedure: Cells are exposed to test compounds, subcultures, and selected for mutants using 6-thioguanine (TG)
- Positive Outcome: Statistically significant, dose-dependent increase in mutant frequency exceeding historical negative control limits