Verax Platelet PGD test receives FDA clearance

Nov 18 2009

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 (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® 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."

SOURCE Fenwal, Inc.