Development and validation of a high-throughput transcriptomic biomarker to address 21st century genetic toxicology needs.

ABSTRACT: Interpretation of positive genotoxicity findings using the current in vitro testing battery is a major challenge to industry and regulatory agencies. These tests, especially mammalian cell assays, have high sensitivity but suffer from low specificity, leading to high rates of irrelevant positive findings (i.e., positive results in vitro that are not relevant to human cancer hazard). We developed an in vitro transcriptomic biomarker-based approach that provides biological relevance to positive genotoxicity assay data, particularly for in vitro chromosome damage assays, and propose its application for assessing the relevance of the in vitro positive results to carcinogenic hazard. The transcriptomic biomarker TGx-DDI (previously known as TGx-28.65) readily distinguishes DNA damage-inducing (

SUBMITTER: Li HH 

PROVIDER: S-EPMC5754797 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature