GREENSCREEN® HELPS J&J IN EARLY IDENTIFICATION OF GENOTOXIC COMPOUNDS

New research published recently in Mutagenesis has confirmed the value to Johnson & Johnson of Gentronix GreenScreen as an effective early screening test for genotoxicity in lead drug candidates.

GreenScreen GC is a eukaryotic genotoxicity assay for simple and rapid screening of lead compounds. The patented assay system is designed for use much earlier in drug discovery than the standard test battery for genotoxicity.

The study tested 2698 J&J proprietary compounds from their compound library, as well as 51 marketed pharmaceuticals. The yeast system was shown to effectively complement AMES-based results by detecting different but overlapping classes of genotoxic compounds and increasing the number of positives from 164 with AMES II assay alone to 328 either positive in AMES II or GreenScreen.

After AMES II positive compounds were rejected, 40 proceeded through pre-clinical development, of which 30 were negative in both the in-vitro regulatory mammalian tests and GreenScreen, demonstrating the new assay’s low level of false positives. 6 of the 10 testing positive in the in-vitro regulatory mammalian tests were also positive for GreenScreen, proving the value of the test as an early screening tool with AMES II negative compounds.

The reliability and reproducibility of GreenScreen was demonstrated as the study compared data for tests carried out at different times by different operators. Results proved the test to be extremely robust as well as being quick and easy to perform and requiring very little compound (<1.0mg).

The main author of this study, Jacky Van Gompel, Head of Genetic and in- vitro Toxicology, Global Preclinical Development Europe, pointed out that these results underline how GreenScreen can “help prevent important genotoxic drug candidates from persisting in development using valuable resources that could be used to develop compounds more likely to be successful drug candidates.”