Genetic Toxicology

Eurofins Medical Device Testing has more than 30 years of experience performing biological safety and activity testing, including a broad range of Genetic Toxicology Studies.

Our certified team has extensive experience in testing medical devices, pharmaceuticals, chemicals, agrochemicals and mixtures. Eurofins Medical Device Testing provides the scientific resources and expertise you need, with the most reliable and timely results possible. Our laboratory team has extensive experience, not only in serving the testing needs of diverse clients, but also in conducting in vitro assay validation studies. Our tests comply with the current international guidelines (e.g. ICH, US-FDA, ISO, EMEA, OECD) and are performed in accordance with GLP to ensure their acceptability worldwide.

Choose Eurofins Medical Device Testing to help you:

• Increase the success of your product development and avoid the risk of genetic damage by choosing the right test design according to ISO 10993-3.
• Rely on our expertise with different in vitro test systems with regard to specific safety and efficacy questions.

Customised Test Designs

The increasing number of newly synthesised molecules demands the use of assays that provide rapid results and require only small amounts of test material. To respond to these market requirements, Eurofins Medical Device Testing laboratories offer miniaturised screening tests, allowing us to screen a large number of substances.

Gene Mutation

• Bacterial Mutation - Ames mutagenicity (OECD 471)[ISO 10993-3]
• Mammalian mutation assay: mouse lymphoma assay (OECD 490) [ISO 10993-3]
• HPRT-test (OECD 476) [ISO 10993-3]
• Pig-a assay

Chromosome Damage

in vitro Cytogenics

• Micronucleus assay (Chinese hamster cell) (OECD 487) [ISO 10993-3]
• Micronucleus assay (human lymphocyte) (OECD 487) [ISO 10993-3]
• Chromosome aberration test (Chinese hamster cells) (OECD 473) [ISO 10993-3]
• Chromosome aberration test (human lymphocytes) (OECD 473) [ISO 10993-3]
• Unscheduled DNA synthesis (UDS) test (mammalian liver cells) (OECD 482) [ISO 10993-3]

in vivo* Cytogenics

• Micronucleus assay (peripheral blood) (rat or mouse) (OECD 474) [ISO 10993-3]
• Micronucleus assay (bone marrow) (rat or mouse) (OECD 474) [ISO 10993-3]
• Chromosome aberration test (mammalian bone marrow) (OECD 475) [ISO 10993-3]
• Comet assay (Lung, Stomach Intestine, Liver, Blood) (OECD 489) [ISO 10993-3]
  
  

Additional Tests

• Embryonic stem cell test
• Syrian hamster embryo (SHE) cell transformation assay
• Drug uptake in vitro
• in vitro hepatocytes proliferation assay (mouse, rat, dog, human)
• Sponsor specific assay establishment

*All in vivo assays are performed by our partner lab