Tailored genetic toxicology testing

You need certainty that your products will not pose mutagenic risks, that they meet international regulatory standards, and that your testing partner can deliver both speed and scientific rigour. At Eurofins BioPharma Product Testing (BPT) network of laboratories, genetic toxicology studies are designed to do exactly that. With a track record of complying with OECD, ICH, US-FDA, ISO, and EMEA guidelines, and with full GLP compliance, we help clients worldwide meet stringent regulatory expectations with confidence.

We offer comprehensive services of in vitro and in vivo genetic toxicology testing to assess the mutagenic potential of your product. While the majority of studies are performed in vitro, in some cases, in vivo genetic toxicology may be necessary. Our experienced scientific teams will advise you on the most appropriate testing strategy. Our familiarity with an array of different in vitro test systems enables us to provide contract testing services using the optimum assays to answer specific product safety and efficacy questions.

With the rise of new molecules synthesised in the pharmaceutical and chemical industries, there is growing demand for rapid assays that require minimal test material. To meet this need,  Eurofins BPT provides miniaturised screening tests, enabling the efficient screening of a high volume of substances. Alongside standard testing, we also offer customised testing with accelerated turnaround times, delivering fast, reliable, efficient results without compromising regulatory compliance. 

Discover our services

Gene mutation

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  • Bacterial mutation - ames mutagenicity (OECD 471)
  • Mammalian mutation assay: mouse lymphoma assay (OECD 490)
  • HPRT-test (OECD 476)
  • Pig-a assay 

in vitro  cytogenics

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  • Micronucleus assay (chinese hamster cell) (OECD 487)
  • Micronucleus assay (human lymphocyte) (OECD 487)
  • Chromosome aberration test (chinese hamster cells) (OECD 473)
  • Chromosome aberration test (human lymphocytes) (OECD 473)
  • 3D skin model combined with micronucleus assay - EpiDerm® Model 

in vivo* cytogenics

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  • Micronucleus assay (peripheral blood) (rat or mouse) (OECD 474)
  • Micronucleus assay (bone marrow) (rat or mouse) (OECD 474)
  • Chromosome aberration test (mammalian bone marrow) (OECD 475) 

*All in vivo assays are performed by our partner lab

DNA strand breaking properties

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  • Comet assay (in vitro and in vivo) (OECD 489)
  • Combination of Micronucleus and Comet Assay
  • 3D skin model combined with micronucleus assay - Phenion® Model 

Additional tests

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  • Embryonic stem cell test
  • Drug uptake in vitro
  • Hepatocyte proliferation assay in vitro (mouse, rat, dog, human)
  • Sponsor specific assay establishment