First commenting round on a Detailed Review Paper to support the application of Error-Corrected Sequencing for in vivo regulatory testing with a focus on amending TG 488

To date, regulatory assays designed to evaluate the mutagenic potential of chemicals and other substances have relied on the detection of phenotypic changes that arise from induced, functional mutations in reporter genes. Up to now, the technologies based on sequencing of nucleic acids known as “next generation sequencing” (NGS) could not be use for the identification of induced mutations, such as those associated with de novo somatic and germ cell mutations that result from exposure to mutagenic chemicals due to the high inherent NGS error rate. In recent years, DNA sequencing has advanced further with the development of error‑correction NGS techniques that can identify chemically induced mutations with a high degree of confidence. The objective of this DRP is to demonstrate the applicability of Error-Corrected Sequencing (ECS) to improve chemical testing, provide additional mechanistic insights, and support the implementation of the 3Rs principles, with a view to its application in regulatory toxicology.

The draft new DRP to support the application of error-corrected sequencing for in vivo regulatory testing with a focus on amending TG 488, is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programme and open for comments from the public at the same time. Interested parties are invited to submit comments to their National Coordinators at least a week before 10 September 2026.

Draft new DRP to support the application of error-corrected sequencing for in vivo regulatory testing with a focus on amending TG 488:  

• Part 1 - Detailed Review Paper and Concordance Analysis
• Part 2 - Validation Report