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TGx-DDI: CEBS Database Website Outline

Publication

Abstract

TGx-DDI (TGx = toxicogenomics; DDI = DNA damage-inducing) is an in vitro transcriptomic biomarker developed by the Health and Environmental Sciences (HESI). By detecting transcriptional changes in key DNA damage response pathways, such as p53-responsive genes, TGx-DDI supports a weight-of-evidence approach in drug development to determine whether test compounds may induce DNA damage relevant to cancer development. The biomarker enhances genotoxicity testing by addressing the low specificity of traditional chromosome damage assays like the micronucleus assay. Its scientific foundation is well-documented, with extensive validation through exploratory and confirmatory studies, including an FDA- funded ring trial. Open-access bioinformatics tools for TGx-DDI analysis are available via NIEHS, and both public and private sector organizations have incorporated it into screening strategies. TGx-DDI has been successfully applied across multiple transcriptomic platforms and cell lines, further demonstrating its versatility in diverse laboratory settings.

Standard Operating Procedures (SOPs) and Guidance

Files

TGx-DDI Classification Tool

Link

Ring Trial Summarized Results

Excel Files

Nanostring nCounter Analysis Systems output

RCC Files

nSolver Output

Lab 1 - Analysis 1

Lab 1 - Analysis 2

    Lab 2 - Analysis 1

    Lab 2 - Analysis 2

    Lab 3 - Analysis 1

    Lab 4 - Analysis 1

    TGx-DDI Publications

    File

    Acknowledgements

    Acknowledgements

    We sincerely thank the Health and Environmental Sciences Institute (HESI) TGx-DDI Working Group members for their valuable input and contributions. We also extend our gratitude to the four ring trial sites for their time and resources in completing this study:

    • Georgetown University: Henghong Li, Al Fornace, Loretta Lin
    • Burleson Research Technologies: Florence Burleson
    • The Procter & Gamble Company: Stefan Pfuhler, Ashley Allemang
    • Sanofi-Aventis Deutschland GmbH: Andreas Czich, Ulrike Hemmann, Yasmin Dietz-Baum, Lena Dorsheimer
    Additionally, we thank the two contract NanoString cores, Wistar Institute and Children’s National Genomics Core, for their contributions.

    This page is for review purposes only and should not be distributed to unauthorized users.