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:12/1/2015)... 1, 2015 Building on its 25-year ... Johnson (NYSE: JNJ ) today announced four ... to significantly reduce the burden of HIV incidence, ... percent of new HIV infections among adolescents in ... Day, these new initiatives include collaborations with the ...
(Date:12/1/2015)... York , December 1, 2015 /PRNewswire/ ... Pills, Contraceptive Injectables, Topical Contraceptives, Male Condoms, ... Contraceptive Vaginal Rings, Contraceptive Diaphragms, Contraceptive Sponges, ... Analysis, Size, Share, Growth, Trends and Forecast ... by Transparency Market Research (TMR).The report states ...
(Date:12/1/2015)... ATLANTA , Dec. 1, 2015   ... automated value cycle solutions, today announced the company ... Pharmacy ChargeLink ® solution at ... 2015 Midyear Clinical Meeting . The new features ... complicated process of monitoring and managing enterprise-wide pharmacy ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 02, 2015 , ... The National Association of ... into its VIP Woman of the Year Circle. She is recognized with this ... exclusively for professional women, boasting 850,000 members and, over 200 operating Local Chapters. ...
(Date:12/1/2015)... ... 01, 2015 , ... Trustify is proud to announce the success of the ... an organization dedicated to ending domestic violence. , Trustify and Becky’s Fund have joined ... survivors of domestic violence. Trustify is also proud to announce the launch of the ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... The Multiple ... drive awareness and funds for Multiple System Atrophy (MSA) research, timed today to coincide ... takes many things from patients including their ability to work and be productive, to ...
(Date:12/1/2015)... ... 2015 , ... World Patent Marketing , a vertically integrated manufacturer ... for easier packing and organizing of items into one big, portable jar. , The ... CEO and Creative Director of World Patent Marketing and Desa Industries Inc . ...
(Date:12/1/2015)... ... December 02, 2015 , ... ClinicoEconomics and Outcomes Research ... of treatment for osteoporosis ”. , As corresponding author Dr Ankita Modi says ... with osteoporosis. Based on a large US managed care database, women aged 55 ...
Breaking Medicine News(10 mins):