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

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.

rdwgroup