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| home > epc > autumn 2002 > comparison of the regulatory ames test with the sos/umu assay as part of lead optimisation screening |
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European Pharmaceutical Contractor
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In our experience, regulatory genetic toxicology testing consistently produces 20-25 per cent in vitro positive results each year (Ames, cytogenetics and mammalian cell mutation). For the customers concerned, this means, at best, significant delays while further testing is carried out using more precious compound. At worst the pharmaceutical will fail further down the development pipeline.
Either way a positive genetic toxicology result leads to considerable cost and delay. The problem is even greater when using the 'fast-track, early into human' approach preferred by some customers when the toxicology study package has been 'compressed' to save time. A significant failure will bring down a whole programme. To aid screening for potential genotoxins, we assessed the performance of the SOS/umu assay, carried out in microwell plates, when compared to the regulatory Ames test performed to OECD guidelines.
Materials and Methods
The SOS/umu assay, performed in microwell plates, has the advantage of being sensitive to a wide range of genotoxins and has been shown to correlate well with the Ames test.
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