Skip to main content

Development and Regulatory approval for Toxicogenomics (TGX) biomarker to detect DNA damage-inducing agents

AAPS | American Association of Pharmacueticals Scientists | Path Course Page

Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately distinguish DNA damage-inducing (DDI) from non-DDI exposures based on changes in the expression of 64 biomarker genes. This In-vitro gene expression signatures have the capability to predict toxicological responses and can provide a mechanistic context for regulatory testing. The panel of 64 biomarker genes could be utilized to facilitate safety genotoxicity hazard assessment in nonclinical studies. Although, the standard genotoxicity testing battery recommended by the international conference on Harmonization, ICH S2(R1), has been successful in preventing the introduction of harmful carcinogens to the marketplace. However, the interpretation of positive genotoxicity finding the in vitro chromosome damage assays for compounds with otherwise negative results in the salmonella reverse mutation assay and in vivo micronucleus test is a major challenge to both industry and regulatory agency. Therefore, HESI Committee on the Application of genomics to Mechanism-based Risk Assessment (HESI Genomics Committee) was issued with the letter for support from Center for Drug Evaluation and Research from Food and Drug Administration. HESI committee received support from FDA to develop a rigorous panel of biomarker to address the need for a reliable follow-up approach for compounds that exhibit these characteristics.

Moderated by

Shraddha Thakkar, FDA and Syril Pettit, HESI e-star

AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

Course Objectives
  • Describe the discovery and development of the toxicogenomic biomarker from discovery to receiving the letter of support process.
  • Describe the developer's point of view for biomarker development point of view.
  • Identify the essential components required for the biomarker development process and will help attendees with an understanding of criteria they would need to go through the qualification process.