Detect Risks Early. Build Confidence Faster.

Genotoxicity testing is crucial to ensuring the materials used in your medical devices do not cause damage to skin, tissue, or organs. Understanding how and when to carry out this testing can be complex. Regulations are continually evolving, and no single test can identify every potential genotoxic risk. Without the right guidance, manufacturers risk unnecessary delays, increased costs, and regulatory setbacks. Determining if testing is required and selecting the appropriate combination of studies to meet regulatory standards such as ISO 10993, calls for expert insight.

With more than 30 years of experience, Eurofins Medical Device Services network of laboratories offers both regulatory clarity and technical precision for your device. Our full range of in vitro and in vivo studies is  aligned with ISO 10993-3, ICH, US-FDA, OECD, and EMEA requirements. In addition, our in silico QSAR modelling identifies potentially hazardous substances early in the process.

Our toxicologists support you in selecting the most appropriate in vitro test systems, carried out in-house, while in vivo assays are performed by our trusted partner labs. As no single method can detect all genotoxic substances, we provide clear recommendations on the types and number of tests needed, avoiding unnecessary delays and additional samples. Whether you need a customised assay design, support in evaluating alternative strategies, or consulting expertise on required testing, our team partners with you to build a strategy tailored to your unique device development goals

A genotoxicity testing strategy  covers three main areas:

  • Chromosome aberration or breakage (clastogenicity)
    • o   Chromosome aberration Test (OECD 473, 475)
  • Chromosome loss or gain (aneuploidy)
    • Micronucleus Assay (OECD 478, 474) 
  • Gene mutations
    • AMES (OECD 471), Mouse Lymphoma Assay (OECD 490), HPRT Test (OECD 476) 

Recommended follow-up evaluations in the event of positive results:

  • Comet with 3D-reconstructed human skin model
  • in vivo chromosome aberration test (OECD 475)
  • in vivo Comet Assay (OECD 489)
  • in vivo micronucleus test (OECD 474)
  • in vivo UDS Test (OECD 486)
  • MNT with 3D-reconstructed human skin model
  • Transgenic mutagenicity tests (OECD 488)

 

*All in vivo assays are performed by our partner lab.

Genotoxicity testing strategy

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Chromosome aberration or breakage (clastogenicity)

Chromosome aberration Test (OECD 473, 475)

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Chromosome loss or gain (aneuploidy)

Micronucleus Assay (OECD 478, 474) 

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Gene mutations

AMES (OECD 471), Mouse Lymphoma Assay (OECD 490), HPRT Test (OECD 476)

Group of four people sitting around a table in a meeting or discussion. The person in the center holds a pen and appears to be engaged in conversation. Items on the table include notebooks, pens, coffee cups, and a water bottle. Abstract wall art with circular and curved shapes in blue, orange, and white is visible in the background.

Recommended follow-up evaluations

in the event of positive results

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Comet with 3D-reconstructed human skin model

Comet with 3D-reconstructed human skin model

in vivo Comet Assay (OECD 489)

in vivo micronucleus test (OECD 474)

in vivo UDS Test (OECD 486)

MNT with 3D-reconstructed human skin model

Transgenic mutagenicity tests (OECD 488)