Error-corrected next-generation sequencing mutagenicity assays in human HepaRG cells as human-relevant genetic toxicology new approach methodology

These findings demonstrate the reproducibility and specificity of ecNGS for detecting low-frequency point mutations and characterizing mutational mechanisms. When combined with complementary cytogenetic assays, duplex sequencing enables a more complete and human-relevant evaluation of genotoxic potential. This study supports the integration of ecNGS into next-generation genotoxicity testing strategies as a NAM for regulatory decision-making.