New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos to be Discussed at AMI's Medical Grade Polymers 2013
AGAWAM,
MASS. – September 3, 2013 – 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 Polymers 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.
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.
Labels: AMI, composites, medical device manufacturing, medical device testing, Medical Grade Polymers 2013, plastics, polymers, toxicity, toxicity testing, zebrafish
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