TGx-DDI (toxicogenomic DNA damage-inducing) biomarker validation: multi-site ring trial supporting regulatory use.

ABSTRACT: Standard in vitro genotoxicity assays often suffer from low specificity, leading to irrelevant positive findings that require costly in vivo follow-up studies. The TGx-DDI (Toxicogenomic DNA Damage-Inducing) transcriptomic biomarker was developed to address this limitation by identifying DNA damage-inducing compounds through gene expression profiling in human TK6 lymphoblastoid cells. To qualify TGx-DDI as a reliable, reproducible biomarker for augmenting genotoxicity hazard assessment, a multi-site ring-trial was conducted across four laboratories using 14 blinded test compounds and standardized protocols. TK6 cells were exposed to three concentrations of each compound, followed by RNA extraction and digital nucleic acid counting using the NanoString nCounter platform. A three-pronged bio

SUBMITTER: Wang X 

PROVIDER: S-EPMC12646585 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature