A new test that utilizes Zebrafish (Danio rerio) embryos to screen plastics, composites, and polymers for toxicity in medical device manufacturing will be featured at AMI’s Medical Grade Polymer 2013 technical conference in September.
“The U.S. Food and Drug Administration (FDA) requires testing to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. The dynamics of such testing are rapidly evolving,” according to Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and a former FDA official.
Dr. Richter developed the new “ZET Medical Device Polymer Biocompatibility Screen Test,” at Microtest Laboratories for use by medical device manufacturers and bio-material researchers.
“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. 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,” he said.
“Moreover, Microtest’s ZET Test sensitivity has proven to be greater than the USP gold standard test for BPA. In addition, the benefits of ZET surpass both USP cytotoxicity testing and mouse embryo toxicity tests,” he said.
Dr. Richter will present details of the new ZET Test in his presentation, “Biocompatibility Testing: Past, Present, and Future,” on Tuesday, Sept. 17, at 10:10 a.m., at the Applied Market Information LLC (AMI) Medical Grade Polymers 2013 conference. The conference runs Sept. 17-18, at the Crowne Plaza, Boston/Woburn, Mass. For more information, visit http://goo.gl/o9edjx.
For more information about Microtest Laboratories’ new ZET Test, download the white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” from http://www.microtestlabs.com/zebrafish-test-paper.