TGx-DDI, A Transcriptomic Biomarker for Genotoxicity Hazard Assessment of Pharmaceuticals and Environmental Chemicals

  • Publication Date :
  • Publication Type : Journal Article
  • Author(s) : Li HH, Yauk C, Chen R, Hyduke DR, Williams A, Frötschl R, Ellinger-Ziegelbauer HC, Pettit S, Aubrecht J, & Fornace Jr. AJ
  • Journal Name : Frontiers in Big Data

Genotoxicity testing is an essential component of the safety assessment paradigm required by regulatory agencies world-wide for analysis of drug candidates, and environmental and industrial chemicals. Current genotoxicity testing batteries feature a high incidence of irrelevant positive findings – particularly for in vitro chromosomal damage (CD) assays. The risk management of compounds with positive in vitro findings is a major challenge and requires complicated, time consuming and costly follow-up strategies including animal testing. Thus, regulators are urgently in need of new testing approaches to meet legislated mandates. Using machine learning, we identified a set of transcripts that responds predictably to DNA-damage in human cells that we refer to as the TGx-DDI biomarker, which was originally referred to as TGx-28.65.

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