Reproducibility and Applicability Domain of devTOX quickPredict, a Human Pluripotent Stem Cell-Based Developmental Toxicity Assay [FutureTox IV (2018)]

Presented at FutureTox IV, a Society of Toxicology (SOT) Contemporary Concepts in Toxicology (CCT) meeting, in Arlington, VA; November 2018

The ICH recently release the draft S5(R3) Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals, which outlines the use of new approach methods (NAMs) in certain circumstances and provides a framework for qualifying a NAM for regulatory acceptance. Part of this framework is to assess the accuracy, demonstrate reproducibility, and define the applicability domain of a NAM.

Over 100 chemicals have been evaluated with the devTOX quickPredict (devTOXqP) assay, which predicts the developmental toxicity potential of a chemical based on changes in human iPS metabolism. The assay predicted the developmental toxicity potential across this diverse set of chemicals with 86% accuracy (84% sensitivity, 87% specificity).