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Classification of Developmental Toxicants in a Human iPSC Transcriptomics-Based Test.

Anna Cherianidou1, Florian Seidel2, Franziska Kappenberg3

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Summary
This summary is machine-generated.

A new in vitro test using human induced pluripotent stem cells (hiPSC) effectively identifies developmental toxicants. The UKK2 test shows high accuracy in predicting teratogenicity at clinically relevant concentrations.

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Area of Science:

  • Developmental Toxicology
  • In Vitro Toxicology
  • Stem Cell Biology

Background:

  • Existing in vitro tests for developmental toxicants often lack correlation with human oral doses and blood concentrations.
  • Accurate identification of developmental toxicants is crucial for human safety during drug development.

Purpose of the Study:

  • To establish and validate a human induced pluripotent stem cell (hiPSC)-based in vitro test (UKK2) for identifying developmental toxicants.
  • To assess the test's performance in classifying known teratogens and non-teratogens based on genome-wide expression profiles.

Main Methods:

  • Utilized hiPSC-derived cells for the UKK2 in vitro test.
  • Analyzed genome-wide expression profiles of 23 teratogens and 16 non-teratogens exposed to maximal plasma concentrations (Cmax) and 20-fold Cmax.
  • Employed penalized logistic regression with leave-one-out cross-validation, incorporating cytotoxicity data, for compound classification.

Main Results:

  • The UKK2 test achieved high performance metrics: AUC of 0.96, accuracy of 0.92, sensitivity of 0.96, and specificity of 0.88.
  • Including cytotoxicity information significantly improved test performance compared to omitting it.
  • Testing at clinically relevant concentrations (1-fold Cmax) yielded comparable results to higher concentrations (20-fold Cmax).

Conclusions:

  • The UKK2 test demonstrates significant potential for early-stage detection of human developmental toxicants.
  • Further optimization, including additional readouts and cell systems, is recommended for broader application.
  • The test provides a valuable tool for assessing developmental toxicity in drug discovery phases.