Assessment of intralaboratory and interlaboratory reproducibility of the devTOX quickPredict assay

BDRP 2026 -- 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. Traditional in vivo animal-based developmental toxicity testing is slow, expensive and may not directly reflect early human developmental biology. The devTOX quickPredict (devTOXqP) assay is an in vitro human pluripotent stem (hPS) cell-based assay that predicts the developmental toxicity potential of chemicals with accuracy based on changes in ornithine and cystine metabolism, represented as the ratio of ornithine to cystine (o/c ratio). Using undifferentiated hPS cells enhances relevance to early human development. devTOXqP has been used by multiple industries for compound prioritization for over a decade and is included as part of the Next Generation Risk Assessment strategies being developed by multiple companies for animal-free assessment of developmental and reproductive toxicity testing. devTOXqP has an accepted Qualification Plan with the FDA CDER Biomarker Qualification Program to qualify the assay as a safety biomarker for detecting human developmental toxicity potential in vitro at the nonclinical stage of drug development for small molecule drugs as part of a weight-of-evidence assessment as described the ICH S5(R3) guideline, which will enable regulatory use of the assay in the pharmaceutical industry. As part of this qualification, we have evaluated the intralaboratory and interlaboratory reproducibility of the assay.