devTOX quickPredict^TM Accurately Predicts the Developmental Toxicity Potential of the ICH S5(R3) Guideline Reference Compounds [BDRP 2022]

Presented by Jessica Palmer at the Society for Birth Defects Research and Prevention Annual Meeting (June, 2022)

• Multiple regulatory agencies have released new guidelines permitting the use of new approach methods (NAMs) in conjunction with or in place of the traditional in vivo embryo-fetal development (EFD) studies.
• In particular, the revised S5 (R3) guideline on Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals recently issued by the  International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines specific scenarios where qualified NAMs can be used to defer or replace conventional in vivo testing or as part of a weight of evidence assessment.
• The devTOX quickPredict^TM (devTOX^qP) assay is an in vitro human pluripotent stem (hPS) cell-based assay that predicts the developmental toxicity potential of chemicals based on changes in ornithine and cystine metabolism.

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