2009-07-14

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 onimproving blood collection, separation, safety and availability,announced today it has signed a five-year exclusive worldwideagreement with Verax Biomedical Incorporated to market, sell anddistribute Verax's unique PanGenera(R) Detection (PGD) technology, arapid diagnostic test used to detect bacterial contaminants indonated blood platelets.

The Verax PGD(R) test is the only rapid test for the detection ofbacteria cleared by the United States Food and Drug Administration(FDA) and CE Marked in Europe. Development is underway to apply theVerax 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 developedby Verax, consists of an easy-to-use disposable handheld device andreagents that work together to detect the presence of bacterialcontaminants in platelets. The test can be performed in fewer than 30minutes and is designed for use in hospitals, cancer centers andother sites of care as a safeguard immediately prior to transfusion.

More than 5 million platelet doses are transfused annuallyworldwide. 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 chemotherapytreatments.

An estimated one in 2,000 to 3,000 platelet units may containbacteria, and up to 50 percent of bacteria-contaminated platelets mayescape detection by conventional culture testing, according toexperts.(i) Bacteria can cause fatal reactions, especially inimmune-compromised patients. The Verax PGD(R) test, a rapidimmunoassay, targets antigens found on the surface of a wide spectrumof common bacteria known to be pathogenic to humans in highconcentrations.

"Bacterial contamination in platelets is a serious concern intransfusion medicine," said Darrell J. Triulzi, M.D., medicaldirector of the Institute for Transfusion Medicine and the Universityof Pittsburgh Medical Center's Division of Transfusion Medicine,which is using the Verax PGD(R) test. "The blood center community hasmade progress with the implementation of culture-based tests, butthese occur at the point of collection when bacteria levels can betoo low for detection. A rapid, point-of-care assay, such as theVerax PGD(R) test, takes place just prior to transfusion, which isthe best time to detect bacteria levels in platelets and provides amore comprehensive strategy for patient safety."

"Transfusion safety is central to the mission of Fenwal and ourcustomers," said Ron K. Labrum, Fenwal president and chief executiveofficer. "This agreement is another example of how Fenwal is bringingadvanced technology, ideas and performance to our vital industry."

"Fenwal is a pioneer in the development of products that improveblood safety worldwide," said Jim Lousararian, Verax president andchief executive officer. "We are confident that with Fenwal's supportwe can increase adoption of the Verax PGD(R) test and improvehealth-care outcomes by reducing transfusion-related issuesassociated with bacterial contamination."

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. The VeraxPGD(R) test is currently cleared by the FDA as a rapid, qualitativeimmunoassay for the detection of bacteria in leukocyte-reducedapheresis platelets as an adjunct quality-control test followingprevious bacterial testing. For more information, visitwww.veraxbiomedical.com.

About Fenwal

Fenwal Inc. is a global medical technology company focused onimproving blood collection, separation, safety and availability forpatient care. Fenwal became an independent company in 2007, but itsroots go back to 1949 with the founding of Fenwal Laboratories.Fenwal developed 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.

(i.) Benjamin R. and Wagner S. The residual risk of sepsis:modeling the effect of concentration on bacterial detection in2-bottle culture systems and estimation of false-negative culturerates. Transfusion 2007; 47:1381-1389.

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

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

Fenwal Inc.

Zurück zur Übersiche Medizin-Nachrichten

Preisvergleich Medikamente
Medikament oder PZN:   
In Zusammenarbeit mit Medizinfuchs

News

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

Medizin-News