Accurate Measure of DNA Damage by Chemical Compounds

Categories: “Diagnostics” “Research Tools

Reference #: 2017-020

OTC Contact: Ruchika Nijhara, Ph.D., MBA, CLP, Director, (Directory Information | Send a Message)


A transcriptomic biomarker that readily distinguishes DNA damage-inducing (DDI) agents from non-DDI agents. DDI agents are defined as those that cause adducts or other DNA lesions such as DNA strand breaks that could result in gene mutations or chromosomal structural aberrations through either direct or certain indirect DNA-damage-like processes that are relevant to in vivo genotoxicity outcomes.

Current laboratory tests that assess chemical toxicity of agents in humans, often result in a high number of false-positive findings for agents that can induce DNA damage. Many of these positive results may reflect cellular toxicity at high chemical doses rather than actual genotoxicity (damage to DNA or genes). Such false-positive results often lead to expensive and time-consuming follow-up testing.

The new test, a biomarker panel referred to as TGx-DDI, is based on genes that are actively transcribed, or expressed, in a cell. These genes reflect particular pathways that respond to various types of stress, and can provide more insight into how cells respond to a particular type of injury, particularly damage to DNA.


  • In-vitro assay, measuring transcriptional DNA damage, thereby assessing carcinogenic risk
  • Investigating genotoxic mechanisms during lead optimization, candidate selection and/or investigational new drug (IND) development


  • Technical reproducibility: results are consistent across chemical agents and laboratories
  • Biomarker can classify agents across a broad set of chemical classes as DDI and non-DDI, de-risking false positive agents
  • The assay can be used in combination with a metabolic activation systems where DDI agents require certain metabolic activation to cause adducts
  • Reduces need for animal testing

Stage of Development

  • Reduced to practice.

Patent Status

Provisional Application Filed


Albert Fornace
Heng-Hong Li