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Biomaterial Genotoxicity Assessment

March 22, 2023

It's important to assess the interaction and impact of biomaterials on mammalian cells in the lab before it's used in the human body.

One example of these mandatory tests to be performed are the genotoxicity tests. Genotoxicity tests are laboratory-based assessment of a biomaterial’s potential to produce compounds that induce genetic damage inhuman cells.

It is of utmost importance to assess this potential genetic damage induced by a biomaterial. Without this test, a biomaterial may cause mutations within the human cells and lead to catastrophic side effects. These catastrophic side effects would manifest as DNA damage in a somatic cell and may lead to malignant transformation (cancer).

To assess this, we use a test called an Ames test.  

The Ames test uses bacterial strains to investigate the potential presence of detrimental mutagenic compounds. The types of bacteria used in this test include Escherichia coli and Salmonella typhimurium. These bacteria are genetically modified so they unable to produce certain amino acids (e.g., histidine or tryptophan) by themselves and are unable to grow without these amino acids.

However, if these bacteria are exposed to a compound that produces a genetic change, the bacteria will change back to being able to produce these amino acids by themselves and be able to grow on agar plates without these amino acids incorporated (figure 1).

Figure 1. Principle of the Ames test.

For a biomaterial, we ensure that the bacteria are exposed to the biomaterial through solid or liquid forms. Using the Ames test we assess the impact on the ability of the bacteria to grow in the absence of the amino acids. If the bacteria are able to grow on the agar plates after incubation, it means that the biomaterial is producing a mutagenic compound. If there no bacteria growing on the agar plate after incubation, it means that the biomaterial is safe for usage in the human body.

These tests follow the guidelines laid out in ISO 10993-3:2003 and ECD Guidelines for the Testing of Chemicals, Section 4 Test No. 471: Bacterial Reverse Mutation Test.  Biohubx is capable of performing these tests to these standards. Please contact Dr. Steven Jones (steve@biohubx.com) for further information.

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Biomaterial Genotoxicity Assessment

When developing medical devices and other biomaterials, it's critical to determine how the material will interact with human cells. Genotoxicity tests like the Ames test measure the potential of a biomaterial to cause genetic damage in human cells. If modified bacteria grow on the plates without nutrients, then a genetic mutation has occurred and it's a genotoxic biomaterial. If not, the biomaterial is safe.