Verax Biomedical Receives 510 (k) Clearance from FDA for Platele... (d for a rapid test likePlatelet PGD. Wit...)

Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test

Date:9/19/2007

d for a rapid test like Platelet PGD. With our ability to enable testing later in platelet unit life, after bacteria have had a chance to grow, blood bankers will have access to a critical new tool in the battle against bacterial contamination."

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 at a later phase in platelet unit life than current culture methods. 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 1 in every 2,000 units are contaminated with bacteria.

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 http://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
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SOURCE Verax Biomedical Inc.
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