Evidence map›Paper›PMID 40035370›Full record

ReviewEnvironmental and molecular mutagenesis2025

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

Heng-Hong Li, Jiri Aubrecht, Tatyana Y Doktorova, Danyel Jennen, J Christopher Corton, Roland Froetschl, Roman Mezencev, Carole L Yauk

Abstract readReview
In one paragraph

Review in Environmental and molecular mutagenesis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Advancing genotoxicity assessment with transcriptomic biomarkers: from 2D to 3D HepaRG spheroid models.Toxicological sciences : an official journal of the Society of Toxicology · 2026
    Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Heng-Hong LiDepartment of Oncology, Georgetown University Medical Center, Washington, Washington, DC, USA.ORCID 0000-0001-5979-5141
Jiri AubrechtDepartment of Oncology, Georgetown University Medical Center, Washington, Washington, DC, USA.
Tatyana Y DoktorovaPredictive Modelling and Data Analytics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Danyel JennenDepartment of Translational Genomics, GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
J Christopher CortonCenter for Computational Toxicology and Exposure, US Environmental Protection Agency, Durham, North Carolina, USA.ORCID 0000-0002-6197-2036
Roland FroetschlFederal Institute for Drugs and Medical Devices, Bonn, Germany.ORCID 0000-0001-8721-7509
Roman MezencevCenter for Public Health and Environmental Assessment, Office of Research and Development, US Environmental Protection Agency, Washington, Washington, DC, USA.
Carole L YaukDepartment of Biology, University of Ottawa, Ottawa, Ontario, Canada.

Funding

Novel genotoxicity assay incorporating the toxicogenomics biomarker TGx-28.65 with a direct digital countingR44ES026473 · NIEHS · AMELIA TECHNOLOGIES, LLC · PI FORNACE, ALBERT J, GEORGE, JAY · 2018 to 2019
$1.5M
NIEHS NIH HHS R44 ES026473
6 · The paper itself

Abstract

The current genotoxicity testing paradigm provides little mechanistic information, has poor specificity in predicting carcinogenicity in humans, and is not suited to assessing a large number of chemicals. Genomic technologies enable the characterization of genome-wide transcriptional changes in response to chemical treatments that can inform mechanisms or modes of action. These technologies provided an impetus to develop transcriptomic biomarkers that could transform genotoxicity hazard assessment for drugs, cosmetics, and environmental and industrial chemicals. In August 2022, the International Workshops on Genotoxicity Testing (IWGT) held a workshop to critically review progress in the development and application of transcriptomic biomarkers in genotoxicity testing. Here, we describe the findings of this workshop's subgroup that conducted a systematized review and analysis of in vitro transcriptomic biomarkers for evaluating genotoxicity. Although there is a multitude of published reports exploring transcriptomics in genetic toxicology, the working group identified only five in vitro transcriptomic biomarker candidates, of which three (GENOMARK, TGx-DDI, and MU2012) were independently developed with sufficiently defined context of use, validation data, and supporting case studies that warranted inclusion in the review. Although these in vitro biomarkers were developed independently and for different classes of chemicals (TGx-DDI for pharmaceuticals, GENOMARK for cosmetics, and MU2012 for medical and environmental chemicals), they all address the same shortfall of the standard in vitro genotoxicity testing battery, that is, lack of specificity by genotoxicity-induced stress response at the transcriptomic level. In this review, we discuss the development of these in vitro biomarkers, including challenges and progress toward achieving regulatory acceptance.

Indexed as

BiomarkersMutagensTranscriptomeCell LineDNA DamageHumansMutagenicity TestsBiomarkersMutagensadverse outcome pathwayDNA damage responsegenotoxicityp53transcriptomic biomarkertranscript profiling

Identifiers

PMID40035370
PMCPMC12353356

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.