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

LAKE ZURICH, Ill., Nov. 17 /PRNewswire/ -- 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® 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® 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 ( 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® 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® 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® separator.

In September 2007, Verax received FDA clearance to market the Platelet PGD® 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® 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® 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® 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

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

SOURCE Fenwal, Inc.

SOURCE Fenwal, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
Post Your Comments:
(Date:11/25/2015)... 25, 2015 Allergan plc (NYSE: AGN ) ... New York State Attorney General,s Office ... Act, and other statutes with the Attorney General over the ... cease marketing and selling the now generic version of memantine ... no liability, has released its counterclaims against New ...
(Date:11/25/2015)... 2015 USP 800 applies to all ... pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home ... also covers all entities which store, prepare, transport, ... healthcare institutions, patient treatment clinics, physicians, practice facilities, ... --> What is the purpose of ...
(Date:11/25/2015)... - Will Also Offer Point -of- ... --> - Will Also Offer Point ... --> - Will Also Offer ... (CME) Elsevier , a world-leading provider of ... diagnostic imaging textbooks and decision support tools, as well as prominent ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... ... Today, Mothers Against Drunk Driving (MADD) learned that the number ... first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol impaired ... Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in 2014. ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When ... that regular bras were incredibly uncomfortable," said an inventor from Bronx, N.Y. "In ... She developed the patent-pending RECOVERY BRA for added comfort and support. The bra ...
(Date:11/25/2015)... ... November 25, 2015 , ... Many people know of the common symptoms ... hands, and dry skin. But many people who find their cholesterol levels and weight ... of their thyroid, especially if they don’t have any of the other symptoms. , ...
(Date:11/25/2015)... ... 2015 , ... Students and parents have something to be thankful for this ... Impact awards. California Casualty is proud to support the contest designed to ... reckless driving, the number one killer of young drivers. , Almost 1,000 entries ...
(Date:11/24/2015)... ... 2015 , ... Eric C. Seidel, DMD and Stephanie DeFilippo, ... revolutionary BIOLASE WaterLase iPlus 2.0™ system. This advanced laser technology uses light energy ... dentist in Gettysburg, PA . From routine visits to cosmetic treatments, laser dentistry ...
Breaking Medicine News(10 mins):