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Fenwal Inc.

Improving Transfusion Safety: Fenwal, Verax Biomedical Sign Agreement for Rapid, Point-of-Care Bacteria Test

Lake Zurich, Illinois (ots/PRNewswire)

Fenwal Inc., a global medical technology company focused on
improving blood collection, separation, safety and availability,
announced today it has signed a five-year exclusive worldwide
agreement with Verax Biomedical Incorporated to market, sell and
distribute Verax's unique PanGenera(R) Detection (PGD) technology, a
rapid diagnostic test used to detect bacterial contaminants in
donated blood platelets.
The Verax PGD(R) test is the only rapid test for the detection of
bacteria cleared by the United States Food and Drug Administration
(FDA) and CE Marked in Europe. Development is underway to apply the
Verax PGD(R) technology to detect bacteria in other blood components,
tissues for transplantation and cell-based therapies.
The Verax PGD(R) test, based on proprietary technology developed
by Verax, consists of an easy-to-use disposable handheld device and
reagents that work together to detect the presence of bacterial
contaminants in platelets. The test can be performed in fewer than 30
minutes and is designed for use in hospitals, cancer centers and
other sites of care as a safeguard immediately prior to transfusion.
More than 5 million platelet doses are transfused annually
worldwide. Platelets are tiny cells in blood that help blood clot.
They are transfused when platelets levels are low - as, for example,
a result of illness or the side effect of some chemotherapy
treatments.
An estimated one in 2,000 to 3,000 platelet units may contain
bacteria, and up to 50 percent of bacteria-contaminated platelets may
escape detection by conventional culture testing, according to
experts.(i) Bacteria can cause fatal reactions, especially in
immune-compromised patients. The Verax PGD(R) test, a rapid
immunoassay, targets antigens found on the surface of a wide spectrum
of common bacteria known to be pathogenic to humans in high
concentrations.
"Bacterial contamination in platelets is a serious concern in
transfusion medicine," said Darrell J. Triulzi, M.D., medical
director of the Institute for Transfusion Medicine and the University
of Pittsburgh Medical Center's Division of Transfusion Medicine,
which is using the Verax PGD(R) test. "The blood center community has
made progress with the implementation of culture-based tests, but
these occur at the point of collection when bacteria levels can be
too low for detection. A rapid, point-of-care assay, such as the
Verax PGD(R) test, takes place just prior to transfusion, which is
the best time to detect bacteria levels in platelets and provides a
more comprehensive strategy for patient safety."
"Transfusion safety is central to the mission of Fenwal and our
customers," said Ron K. Labrum, Fenwal president and chief executive
officer. "This agreement is another example of how Fenwal is bringing
advanced technology, ideas and performance to our vital industry."
"Fenwal is a pioneer in the development of products that improve
blood safety worldwide," said Jim Lousararian, Verax president and
chief executive officer. "We are confident that with Fenwal's support
we can increase adoption of the Verax PGD(R) test and improve
health-care outcomes by reducing transfusion-related issues
associated with bacterial contamination."
About Verax Biomedical
Verax Biomedical Inc. is a leading developer of rapid tests for
detecting bacterial contaminants in blood cells and tissue. The
privately held company was founded in 1999. Its headquarters and
laboratory facilities are in Worcester, Massachusetts. The Verax
PGD(R) test is currently cleared by the FDA as a rapid, qualitative
immunoassay for the detection of bacteria in leukocyte-reduced
apheresis platelets as an adjunct quality-control test following
previous bacterial testing. For more information, visit
www.veraxbiomedical.com.
About Fenwal
Fenwal Inc. is a global medical technology company focused on
improving blood collection, separation, safety and availability for
patient care. Fenwal became an independent company in 2007, but its
roots go back to 1949 with the founding of Fenwal Laboratories.
Fenwal developed the first flexible, disposable container for blood
collection, eliminating complications associated with glass
containers and allowing blood to be separated into therapeutic
components. Today, the company's products and advanced collection and
separation technologies are used throughout the world to help ensure
a safe and available supply of lifesaving blood and blood products.
Fenwal Inc. is based in Lake Zurich, Illinois. For more information,
please visit www.fenwalinc.com.
(i.) Benjamin R. and Wagner S. The residual risk of sepsis:
modeling the effect of concentration on bacterial detection in
2-bottle culture systems and estimation of false-negative culture
rates. Transfusion 2007; 47:1381-1389.

Contact:

Geoffrey Fenton of Fenwal Inc., +1-847-550-2321,
geoffrey.fenton@fenwalinc.com

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