Verax Biomedical Receives 510 (k) Clearance From FDA For Platelet PGD Test

Main Category: Medical Devices / Diagnostics
Also Included In: Infectious Diseases / Bacteria / Viruses;  Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 20 Sep 2007 - 0:00 PDT

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Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received 510 (k) clearance for its Platelet PGD Test System from the U.S. Food and Drug Administration (FDA). This provides Verax authorization to market the device, which cuts the detection time for bacterial contamination in leukocyte reduced apheresis platelets to approximately 30 minutes.

The clearance comes on the heels of the execution of key agreements with Abbott Diagnostics to serve as distributor and British Biocell International to serve as manufacturer of the product. The data from US clinical studies that served as the basis of the Company's 510 (k) filing will be featured in 7 poster presentations at the upcoming Annual Meeting of the American Association of Blood Banks (AABB) in Anaheim, California October 20th - 23rd.

To combat the risk of bacterial contamination, the AABB requires all of its members to detect and limit contamination in platelets. Recent articles published in Transfusion, the journal of the AABB, indicate that current culture testing methods fail to detect half of the contaminated units in the U.S. inventory and false negative results associated with this testing have resulted in 26 documented septic transfusion reactions including 5 fatalities since testing began in 2004. The Platelet PGD test is designed to allow testing after platelets have entered the inventory and offers clinicians the opportunity to detect contaminated units that slip past current testing methodologies.

"We are thrilled to achieve this critical milestone," said Jim Lousararian, chief executive officer of Verax Biomedical. "The increasing recognition of culture false negative results associated with current platelet testing clearly illustrates the need 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.

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.

Verax Biomedical Inc.
http://www.rdwgroup.com