Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.
“Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals,” said Steven Richter, PhD, president and scientific director of Microtest Laboratories, and former US Food & Drug Administration (FDA) official.
“We've confirmed the application of Zebrafish embryos in the toxicity testing of materials used in medical devices,” Dr Richter said. “With our in-vitro test, manufacturers and bio materials researchers can screen thousands of polymers in less than a week — yielding significant economic savings in both the time and expense of medical device testing.”
In its research, Microtest Laboratories 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 extract during testing — while Microtest's new Zebrafish embryo screen succeeded.
BPA (bis-phenol A) is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The US Environmental Protection Agency (EPA) has indicated that BPA will be slated for screening soon.
“Microtest's new Zebrafish embryo assay has better sensitivity and generates more scientific data than the small animal tests currently recommended by the FDA,” Dr Richter said.
“The use of Zebrafish embryos will reduce or eliminate the current animal testing required for all medical devices testing. This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing,” he noted.
Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries.