2009-11-17

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 onimproving blood collection, separation, safety and availability,announced today that the U.S. Food and Drug Administration hascleared the Verax Platelet PGD(R) test as a quality control test todetect bacterial contamination in whole blood-derived, pooledplatelets prior to transfusion. Fenwal is the exclusive globaldistributor of the test, which was developed by Verax Biomedical ofWorcester, Mass.

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

Bacterial contamination in platelets is a serious threat totransfusion safety. More than 5 million platelet doses are transfusedannually worldwide. Studies show that up to 1 in 2,000 doses maycontain bacteria, which can cause a range of reactions, includingdeath, especially in immune-compromised patients.

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

"Until now, there was no rapid test cleared by the FDA fordetecting 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 currentStandards regarding 'methods to limit and to detect bacteria in allplatelet components.'"

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

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

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

In September 2007, Verax received FDA clearance to market thePlatelet PGD(R) test as an adjunct test to detect bacteria inleukocyte-reduced, apheresis platelets following culture testing byan FDA-cleared test. Recent studies, including post-marketsurveillance from Verax, show that up to 70 percent of unitscontaining bacteria may escape detection by culture testing, whichoccurs following collection when bacteria may still be at levels toolow for detection by culture sampling. The Verax Platelet PGD(R) testis used within a few hours before transfusion, when bacteria, ifpresent, have had a chance to grow to higher, more threateninglevels.

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

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

About Verax Biomedical

Verax Biomedical Inc. is a leading developer of rapid tests fordetecting bacterial contaminants in blood cells and tissue. Theprivately held company was founded in 1999. Its headquarters andlaboratory facilities are in Worcester, Massachusetts. For moreinformation, visit www.veraxbiomedical.com.

About Fenwal

Fenwal, Inc. became an independent company in 2007, but its rootsgo back to 1949 with the founding of Fenwal Laboratories. Fenwaldeveloped the first flexible, disposable container for bloodcollection, eliminating complications associated with glasscontainers and allowing blood to be separated into therapeuticcomponents. Today, the company's products and advanced collection andseparation technologies are used throughout the world to help ensurea 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

Fenwal Inc.

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