AGAWAM, MASS. – February 13, 2012 – A new white paper detailing the new ZET™ medical device polymer biocompatibility screening test using Zebrafish embryos is available to download from Microtest Laboratories at http://www.microtestlabs.com/zebrafish-test-paper.
The new ZET test was developed by Microtest Laboratories for medical device manufacturers and biomaterials researchers. It utilizes Zebrafish (Danio rerio) to screen plastics, composites, and polymers for toxicity.
“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times,” writes white paper author Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official. “The Zebrafish 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 the new white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” 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 the company’s 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.
About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter@MicrotestLabs at http://twitter.com/MicrotestLabs.
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