Control Performance of Amphibian Metamorphosis Assays with Xenopus laevis

  • Publication Date :
  • Publication Type : Journal Article
  • Author(s) : Wheeler et al.
  • Journal Name : Regulatory Toxicology and Pharmacology

The Health and Environmental Sciences Institute's (HESI) Next Generation Ecological Risk Assessment Committee is proud to announce the release of new publication: "Control Performance of Amphibian Metamorphosis Assays with Xenopus laevis."

This study addresses variability challenges in the Amphibian Metamorphosis Assay (AMA), a widely used assay to detect the endocrine-disrupting effects of chemicals on the thyroid system. By analyzing data from 52 studies across seven laboratories, the paper highlights how variability in controls affects the assay's reliability and provides actionable solutions to improve its consistency and interpretability.

Why It Matters:

  • Protecting Ecosystems and Public Health: The AMA helps identifies chemicals that disrupt thyroid function, helping safeguard wildlife and human health from harmful environmental exposures.
  • Regulatory Impact: Enhanced assay performance strengthens confidence in regulatory decision-making and enables harmonized global standards for chemical safety assessments.

Key Highlights:

  • Identification of variability drivers in biological endpoints such as growth and development.
  • The utility of historical control data (HCD) for contextualizing results and optimizing study designs.
  • Proposed refinements to OECD and US EPA guidelines to ensure reliability while minimizing animal use.
  • Insights into how New Approach Methodologies (NAMs) can complement or replace the AMA.

Potential Benefits:

  • Resolving these issues will result in more reliable scientific outcomes, efficient regulatory processes, and potential reduced animal use.

Read the full article at the link below:

Control Performance of Amphibian Metamorphosis Assays with Xenopus laevis. Wheeler et al., 2025. Regulatory Toxicology and Pharmacology.  https://doi.org/10.1016/j.yrtph.2025.105773

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