FDA News

Verax Biomedical Submits 510 Application to FDA for Platelet PGD Test

(March 14, 2007)-- Verax Biomedical, developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has submitted a 510 (k) application to the U.S.Food and Drug Administration (FDA) for its Platelet PGD Test. This filing is based on data gathered at three major U.S. hospitals and is intended to
demonstrate that the performance of the product is substantially equivalent to existing FDA cleared tests for the detection of bacterial contaminationin platelets.

FDA clearance of the test would permit Verax to market the device, which cuts the detection time for bacterial contamination to approximately 30 minutes compared to the one- to three-day detection times of currently available tests.The filing comes in advance of anticipated strong worldwide demand for the Verax Platelet PGD Test. Recently, Abbott Diagnostics signed a worldwide exclusive agreement to market and distribute the product, and British Biocell International (BBI) signed a 10-year contract to provide gold colloid and manufacturing.

The Platelet PGD Test is an easy-to-use, disposable device designed to detect the presence of a broad range of bacterial contaminants in platelets prior to transfusion. Bacterial contamination in platelets and red blood
cells represents the single greatest risk for lethal infections in transfusion medicine today. An estimated 10 million platelet units are transfused each year into patients in North America, Europe and Asia, and experts estimate that as many as one in every 2,000 units could be contaminated with bacteria.

To combat the risk of bacterial contamination, the American Association of Blood Banks requires all of its members to detect and limit contamination in platelets. Current culture testing methods miss at least
half of all bacterial contaminations and take up to three days before results are available. In comparison, the Verax Platelet PGD Test is designed to produce results in less than 30 minutes, and targets all species of bacteria known to cause diseases in humans.

"We get calls everyday from blood banks and hospitals eager to add our Platelet PGD Test to their protocols," said Jim Lousararian, chief executive officer of Verax Biomedical. "The 510 (k) filing brings us one step closer to marketing this product - and allowing clinicians to use it to ensure safer blood products."

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