The Mouse Lymphoma uses cell cultures, usually mammalian, to determine gene mutations, change in chromosome structure and number, and other gene toxicities caused by medical devices, material, or their extracts. These tests are used to ensure devices that have prolonged contact with the body do not elicit genotoxicity that in turn might cause gene mutations with a potential for cancer. Biocompatibility Genotoxicity tests comply with ISO 10993-1 and ISO 10993-3 standards.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
Applicable Standards
- ISO 10993-3
Sample Specifications
SCX530: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
Study Outline
In the Biocompatibility Genotoxicity test, mouse lymphoma cells are used to determine whether a test material has the capacity to induce either point mutations or clastogenic (chromosomal breakage) events in a cultured mammalian cell line. In this case, the target gene, thymidine kinase (TK), is a dispensable gene. Loss of TK activity indicates a mutation has occurred. Because TK is involved in a salvage pathway for thymidine derived from DNA metabolism, the cells can synthesize thymidine de novo. Therefore, the loss of the TK does not render the cell nonviable.
Mutants can be selected and mutant frequencies derived by including a thymidine analog (trifluorothymidine or TFT) in the culture medium of cells after exposure to the test material. Normal cells with intact TK incorporate the analog and die; mutant cells (which lack TK activity) survive, form colonies, and are quantified.
