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Review of Transcriptomic Biomarkers That Predict In Vitro Genotoxicity in Human Cell Lines.

Heng-Hong Li1, Jiri Aubrecht1, Tatyana Y Doktorova2

  • 1Department of Oncology, Georgetown University Medical Center, Washington, Washington, DC, USA.

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Summary

New transcriptomic biomarkers offer improved mechanistic insights for genotoxicity testing, addressing limitations in predicting human carcinogenicity. Three key biomarkers (GENOMARK, TGx-DDI, MU2012) show promise for regulatory acceptance in evaluating chemical safety.

Keywords:
DNA damage responseadverse outcome pathwaygenotoxicityp53transcript profilingtranscriptomic biomarker

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Area of Science:

  • Toxicology
  • Genomics
  • Biomarker Development

Background:

  • Current genotoxicity testing lacks mechanistic detail and human carcinogenicity prediction accuracy.
  • Genomic technologies offer genome-wide transcriptional data to understand chemical mechanisms of action.
  • Transcriptomic biomarkers are emerging to enhance genotoxicity hazard assessment for various chemical classes.

Purpose of the Study:

  • To critically review the development and application of in vitro transcriptomic biomarkers for genotoxicity testing.
  • To identify and analyze promising transcriptomic biomarker candidates based on systematized review.
  • To discuss challenges and progress toward regulatory acceptance of these novel biomarkers.

Main Methods:

  • Systematized review and analysis of published literature on in vitro transcriptomic biomarkers.
  • Identification of biomarker candidates with defined context of use, validation data, and case studies.
  • Workshop discussions by the International Workshops on Genotoxicity Testing (IWGT) subgroup.

Main Results:

  • Only five in vitro transcriptomic biomarker candidates were identified, with three (GENOMARK, TGx-DDI, MU2012) meeting inclusion criteria.
  • These biomarkers, developed independently for pharmaceuticals, cosmetics, and medical/environmental chemicals, address the lack of specificity in standard genotoxicity tests.
  • All identified biomarkers detect genotoxicity-induced stress responses at the transcriptomic level.

Conclusions:

  • Transcriptomic biomarkers represent a significant advancement over traditional genotoxicity testing methods.
  • GENOMARK, TGx-DDI, and MU2012 show potential for transforming genotoxicity hazard assessment.
  • Further progress and validation are needed to achieve widespread regulatory acceptance for these biomarkers.