A Collaborative Initiative to Establish Genomic Biomarkers for Assessing Tumorigenic Potential to Reduce Reliance on Conventional Rodent Carcinogenicity Studies

Most global regulatory safety assessment standards for agrochemicals and pharmaceuticals require the rodent 2-year bioassay for evaluating the carcinogenic potential of a new chemical. The low-end estimate of resources required for said test is 3 years, 600 animals and ~$2–4M USD. There is increasing interest across industry and government to reduce reliance on these long animal studies with the use of novel genomic biomarkers, but more confidence in the newer tools is still required.

The HESI Emerging System Toxicology for the Assessment of Risk (eSTAR) Carcinogenomics Workgroup is a multi-stakeholder scientific collaboration working to develop genomic biomarkers to query established mechanisms of early carcinogenic processes that can be applied to samples already collected from required shorter duration studies and provide greater insights to relevancy for predicting human cancer risk.

This call-to-action paper describes the multi-sector collaboration seeking to accelerate the evaluation of biomarker tools in carcinogenicity studies which will facilitate the transition from current heavy reliance on conventional 2-year rodent carcinogenicity studies to more rapid animal- and resource-sparing approaches.

Click to read the full publication:

A Collaborative Initiative to Establish Genomic Biomarkers for Assessing Tumorigenic Potential to Reduce Reliance on Conventional Rodent Carcinogenicity Studies. J. Christopher Corton, Constance A. Mitchell, Scott Auerbach, J. Pierre Bushel, Heidrun Ellinger-Ziegelbauer, Patricia A. Escobar, Roland Froetschl, Alison H. Harrill, Kamin Johnson, James E. Klaunig, Arun R. Pandiri, Alexei A. Podtelezhnikov, Julia E. Rager, Keith Q. Tanis, Jan Willem van der Laan, Alisa Vespa, Carole L. Yauk, Syril D. Pettit, Frank D. Sistare. Toxicological Sciences. July 2022

Click to learn more about the Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee

Click to learn more about the Health and Environmental Sciences Institute (HESI)