Zebrafish Toxicology Testing
Microtest has confirmed and implemented the application of zebrafish embryos (Danio rerio) in screening for toxicity in the materials used in medical device design and manufacture. With the company's new in-vitro toxicology test, medical device manufacturers and biomaterials researchers can screen thousands of polymers in less than a week — yielding significant economic value in terms of time and expense.
Fast-track zebrafish toxicology testing is a much more robust and sensitive model for evaluating vertebrate development pathways and toxicity than small-animal models. Genotoxicity and developmental toxicity are readily viewable through the transparent embryo during development. Microtest's zebrafish embryo assay has better sensitivity and generates more scientific data than the small-animal tests currently recommended by the U.S. Food and Drug Administration (FDA). It also saves time and money because the embryos develop in 24 hours.
Zebrafish embryo assay eliminates small-animal testing
Due to the high degree of conservation with other vertebrates, the zebrafish is becoming an important tool for many areas of biomedical research, including cancer biology, cardiovascular disease, aging, and toxicology. Zebrafish labs are ubiquitous in most universities and research hospitals. In addition, the test has been used for the past 10 years for pharmaceutical toxicity analysis. There is growing literature on the use of the zebrafish to model human disease.
This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing. Research has revealed that zebrafish embryos are highly susceptible to toxins. Zebrafish embryo testing will reduce or eliminate the current animal testing required for all medical devices.
Currently, the FDA requires biocompatibility testing for medical devices according to ISO 10993. Extracts of medical devices (or components) are tested according to standard procedures. These procedures utilize small animal models or cell cultures. The testing encompasses systemic toxicity, irritation, sensitization, and implantation requirements. These tests do not give one a complete toxicological profile. Most tests are subjectively scored.
In its research, Microtest found that the current "gold standard" USP cytotoxicity assay, which utilizes live mouse fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA (bis-phenol A) extract during testing, while Microtest's new zebrafish embryo screen succeeded. (BPA is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The U.S. Environmental Protection Agency has indicated that BPA will be slated for screening soon.)