Abstract
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. A new test, developed by the company and called the ZET™ medical device polymer biocompatibility screening test (ZET), utilises Zebrafish (Danio rerio) to screen plastics, composites, and polymers for toxicity, an essential component in the development of medical devices and used by biomaterials researchers.
Company comment
“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.”
New white paper
In a new white paper, which can be downloaded here, 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.
Source: Microtest Laboratories
published: February 14, 2012 in: Products, Technology, USA