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

Experts to Re-examine Guidance for Platelet Testing

LAKE ZURICH, Illinois, November 17 - 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.

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