GH2AX/pH3 Biomarkers For The Prediction Of DNA Damage - TSAR

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  5. gH2AX/pH3 biomarkers for the prediction of DNA damage
gH2AX/pH3 biomarkers for the prediction of DNA damage

Topic: Genotoxicity/Mutagenicity

Test Method Number: TM2017-01 (EU) Short Name of TM: gH2AX/pH3 Year received: 2017 Responsible Organisation: EURL ECVAM - European Union General Comments: Presubmission assessment finalised. Method Not prioritised for validation

Method Description

The proposed method is based on gH2AX/pH3 biomarkers for the prediction of genotoxic potential of all kind of substances. The combination of the two biomarkers is proposed to detect early events in the DNA damage response and to discriminate structural and numerical chromosome damage. This assay is applicable to almost all cell types including cells of human origin. The assay use innovative techniques with a higher throughput than usual assays and potentially amenable to automation. The method is less prone to irrelevant positive results as compared to some of the current assays because is able to also discriminate the misleading cytotoxic chemicals.

Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
Step Expand All
Submission Show status
Date Stage Comment Documents/Links
Jul 2017 Receipt of presubmission Receipt of pre-submission of method
Feb 2018 Stopped Submitter notified of presubmission outcome. No invitation to full submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

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