Verax Biomedical, Incorporated Submits 510(k) Application to FDA for Platelet PGD Test
Published: Mar 14, 2007
WORCESTER, Mass., March 14 /PRNewswire/ -- Verax Biomedical Inc., a leading 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 contamination in 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."
The Verax PGD Test is based on Verax Biomedical's proprietary Pan Genera(R) Detection technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.
For additional information, visit www.veraxbiomedical.com. Verax is located at 377 Plantation Street, Worcester, MA 01608. Tel.: 508-755-7029.
About Verax Biomedical, Inc.
Based in Worcester, Mass., Verax Biomedical is a leader in the development of rapid tests designed to detect a broad range of bacterial contaminants based upon its proprietary Pan Genera Detection (PGD) technology. The first target application for its technology is to test for the presence of bacterial contaminants in the blood supply. Bacterial contaminants in platelets and red blood cells represent the greatest lethal infectious risks in transfusion medicine today, and no rapid, simple methods are presently available to effectively address this threat. Each year an estimated 17 million patients receive more than 60 million units of these individual blood components in North America, Europe and Asia.
Contact: Sam Everett
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CONTACT: Sam Everett of Verax Biomedical, Inc., +1-508-795-0535, firstname.lastname@example.org
Web site: http://www.veraxbiomedical.com//