The devTOX quickPredict™ assay: A high reproducible in vitro NAM for developmental toxicity prediction as demonstrated by an interlaboratory blinded study

SOT 2026 -- Traditional in vivo animal-based developmental toxicity testing is slow, expensive and may not directly reflect human developmental biology. devTOX quickPredict™ is a fast, low‑cost human in vitro assay using human induced pluripotent cells (hiPSCs) and metabolomic biomarkers. It predicts developmental toxicity by tracking changes in ornithine/cystine ratios across a dose‑response curve. A compound’s developmental toxicity potential (dTP) is defined by when this ratio crosses a developmental toxicity threshold (dTT). The method can detect toxicity at non‑cytotoxic doses, reducing false signals from cell death. Using undifferentiated hiPSCs enhances relevance to early human development. The Stemina/Labcorp partnership was formed to supply data from a second lab to the FDA Biomarker Qualification Program (FDA BQP) application. All knowledge was transferred from Stemina to Labcorp, and full training was provided to establish the assay at Labcorp’s In Vitro Toxicology laboratories (Harrogate, UK).