FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets

Lake Zurich, Illinois, November 17 (ots/PRNewswire) -

- Experts to Re-examine Guidance for Platelet Testing

Fenwal, Inc., a global medical technology company focused on
improving blood collection, separation, safety and availability,
announced today that the U.S. Food and Drug Administration has
cleared the Verax Platelet PGD(R) test as a quality control test to
detect bacterial contamination in whole blood-derived, pooled
platelets prior to transfusion. Fenwal is the exclusive global
distributor of the test, which was developed by Verax Biomedical of
Worcester, Mass.

The Verax Platelet PGD(R) test is the only rapid diagnostic test
to receive FDA clearance for detecting bacteria in both pooled and
single-donor platelets. The test can be performed in approximately 30
minutes and is designed for use in hospitals, cancer centers and
other sites of care as a safeguard prior to transfusion.

Bacterial contamination in platelets is a serious threat to
transfusion safety. More than 5 million platelet doses are transfused
annually worldwide. Studies show that up to 1 in 2,000 doses may
contain bacteria, which can cause a range of reactions, including
death, especially in immune-compromised patients.

The international blood transfusion association AABB
(www.aabb.org) issued an Association Bulletin in July 2009 stating
that "after publication of data sufficiently robust to support
application of an assay appropriate for use near the time of platelet
issue, the current standard will be reappraised. At that time, AABB
intends to promulgate an interim standard to require enhanced methods
of bacterial detection in WBD platelets-either by specifically
prohibiting the use of less sensitive methods such as pH or glucose,
or by establishing a minimum sensitivity level for methods used to
detect bacteria." The Verax Platelet PGD(R) test is an example of
such an assay.

"Until now, there was no rapid test cleared by the FDA for
detecting bacteria in whole-blood derived platelets," said Louis M.
Katz, M.D., chair of AABB's Task Force on Bacterial Contamination.
"With such a test now available, we will reexamine the current
Standards regarding 'methods to limit and to detect bacteria in all
platelet components.'"

AABB member facilities are responsible for collecting virtually
all of America's blood supply and transfusing more than 80 percent of
all blood and blood components in the United States. The
organization's members operate in 80 countries worldwide.

"We are pleased that Verax has received clearance for use of the
Platelet PGD(R) test on whole blood platelets," said Darrell Triulzi,
M.D., medical director of the Institute for Transfusion Medicine and
the University of Pittsburgh Medical Center's Division of Transfusion
Medicine. "We are a large user of pooled platelets and have sought a
more sensitive method for bacterial screening. The Verax test from
Fenwal fills this role with a point-of-issue test that we are
confident will reduce the risk of bacterial-contamination reactions.
Our preliminary experience indicates that it works well in the
transfusion service work flow and that the technologists who
administer the test find it easy to use."

Platelets are collected from whole-blood donations or via
apheresis. With whole-blood donations, platelets from four to six
whole-blood donors are pooled to produce a single, transfusion dose.
In an apheresis platelet donation, a single donor can give one or
more transfusion doses of platelets via a machine such as the Fenwal
Amicus(R) separator.

In September 2007, Verax received FDA clearance to market the
Platelet PGD(R) test as an adjunct test to detect bacteria in
leukocyte-reduced, apheresis platelets following culture testing by
an FDA-cleared test. Recent studies, including post-market
surveillance from Verax, show that up to 70 percent of units
containing bacteria may escape detection by culture testing, which
occurs following collection when bacteria may still be at levels too
low for detection by culture sampling. The Verax Platelet PGD(R) test
is used within a few hours before transfusion, when bacteria, if
present, have had a chance to grow to higher, more threatening
levels.

"With the recent FDA clearance for the Verax Platelet PGD(R)
test, we can partner with industry to offer a higher level of safety
across all platelet inventories," said Ron Labrum, Fenwal president
and chief executive officer. "We continue to pursue similar
opportunities to make a meaningful difference in transfusion medicine
by bringing advanced technology, ideas and performance vital to our
industry."

The Verax Platelet PGD(R) test, based on proprietary technology
developed by Verax, targets common antigens found on the surface of
all species of bacteria known to be pathogenic to humans. It consists
of an easy-to-use disposable handheld device, similar in size and
appearance to a pregnancy test, and reagents that work together to
detect the presence of bacterial contaminants in platelets.

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. For more
information, visit www.veraxbiomedical.com.

About Fenwal

Fenwal, Inc. 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.

ots Originaltext: Fenwal Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Tanya Tyska of Fenwal, Inc., +1-847-550-2732,
tanya.tyska@fenwalinc.com