Study focuses on in vitro toxicogenomics

The study indicated that these methods are sufficiently robust and reproducible to allow their further investigation in regulatory risk assessment.

In collaboration with the Fund for the Replacement of Animals in Medical Experiments (FRAME) Unilever, Agilent and the Institute for Health and Consumer Protection of the European Commission's Joint Research Centre, LGC designed an inter and intra-laboratory study to assess whether the current generation of microarray technology is capable of generating robust, reproducible data of sufficient quality to show promise as a tool for regulatory risk assessment.

Toxicogenomics merges toxicology with genomics and bioinformatics to investigate global molecular and cellular effects of chemicals in biological systems.

While this platform has been evaluated over the past 10-15 years in the pharmaceutical and chemical industries, improvements in microarray technology have made the platform more robust, thereby potentially offering a suitable alternative to costly animal testing.

As a case study, three of the laboratories analysed a human liver cell model (HepG2) for gene expression, following 24-hour exposure to the genotoxic carcinogen benzo(a)pyrene.

Exposure of HepG2 cells to benzo(a)pyrene has been used as an archetypal model for research into the mechanisms of genetic toxicology and forms the basis for many standardised testing studies.

The abundance of existing data from previous toxicogenomic studies enabled direct comparisons with results from this research.

Mimicking a real-life regulatory testing environment and incorporating a controlled standard operating procedure, the inter-laboratory study produced reproducible datasets, with each laboratory identifying the same key biological responses characteristic of a benzo(a)pyrene response.

This provides further evidence that toxicogenomics can predict chemical toxicity in vitro and, importantly, it also shows that the technology can produce data of sufficient quality to show promise as a tool for toxicity testing in a regulatory setting.