The FDA is phasing out the requirement for animal testing in drug development — a move that paves the way for faster, more ethical, and human-relevant preclinical models. BioReperia’s zebrafish tumor xenograft platform is already aligned with this direction, offering a validated in vivo system for efficient oncology drug screening.

The U.S. Food and Drug Administration (FDA) has recently announced a landmark plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs. This decision signals a significant transformation in the pharmaceutical and biotech industries, opening the door for innovative and more human-relevant preclinical models.

Read the full announcement from the FDA

As the industry moves away from traditional animal models, the need for validated, regulatory-aligned alternatives becomes increasingly important. BioReperia’s CE-marked zebrafish tumor xenograft platform is specifically designed to meet this demand. Our platform enables in vivo evaluation of drug efficacy using human cancer cells in a living organism, offering fast, reproducible, and cost-effective results — with high translational value to human biology.

Unlike conventional rodent models, our zebrafish xenograft system allows for:

  • Rapid screening of multiple drug candidates and cancer indications (link to page).
  • Evaluation of metastasis and tumor angiogenesis (link to page).
  • Rapid screening of multiple PDX models (link to page).
  • De-risk clinical trials by screening patient biopsies for patient stratification and use as companion diagnostics tool (link to page).
  • Prediction of patient treatment outcome and disease prognosis (link to page).

These advantages make the zebrafish model a powerful tool for identifying the most promising compounds before entering more complex and expensive stages of the pipeline and doing so in full alignment with the 3Rs principles:

Replacement: Zebrafish embryos are not classified as animals under current EU and U.S. regulations for early-stage development. This allows us to generate in vivo data while replacing higher-order animal use during early preclinical decision-making.

Reduction: Our model offers high-content, actionable results within just 5 days, reducing the number of animals needed per study. With medium-throughput capacity and real-time imaging, we enable early elimination of ineffective compounds, helping our partners streamline development and minimize resource use.

Refinement: Zebrafish embryos develop ex utero, are fully transparent, and require no invasive procedures for tumor monitoring. Our approach allows for precise, non-invasive assessment of tumor growth, metastasis, and angiogenesis, providing high-quality data while ensuring minimal distress and maximal refinement of animal use.

With regulatory bodies such as the FDA signaling a shift in acceptable preclinical methods, zebrafish xenografts represent a future-ready solution that supports both ethical research practices and efficient drug development strategies.

At BioReperia, we are proud to contribute to this paradigm shift by offering cutting-edge in vivo tools that align with evolving regulatory standards and the growing demand for patient-relevant data.

For pharmaceutical and biotech partners looking to de-risk oncology programs, reduce development time, and streamline preclinical workflows, BioReperia is ready to collaborate.