New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio)

A white paper by Steven Richter, Ph.D.

A new test has been developed for medical device manufacturers and biomaterials researchers to screen plastics, composites, and polymers for toxicity. This ZET™ test utilizes zebrafish (Danio rerio). Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. This test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses.

In this white paper, Richter discusses U.S. Food and Drug Administration (FDA) testing requirements to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs.

Richter also provides background facts about Zebrafish and details testing that revealed ZET sensitivity is greater than USP gold standard test for BPA. In addition, he outlines the benefits of ZET versus USP cytotoxicity testing and ZET versus mouse embryo toxicity tests.

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