First rapid test cleared for the detection of bacterial contamination in
WORCESTER, Mass., Sept. 19 /PRNewswire/ -- Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received 510 (k) clearance for its Platelet PGD Test System from the U.S. Food and Drug Administration (FDA). This provides Verax authorization to market the device, which cuts the detection time for bacterial contamination in leukocyte reduced apheresis platelets to approximately 30 minutes.
The clearance comes on the heels of the execution of key agreements with Abbott Diagnostics to serve as distributor and British Biocell International to serve as manufacturer of the product. The data from US clinical studies that served as the basis of the Company's 510 (k) filing will be featured in 7 poster presentations at the upcoming Annual Meeting of the American Association of Blood Banks (AABB) in Anaheim, California October 20th - 23rd.
To combat the risk of bacterial contamination, the AABB requires all of its members to detect and limit contamination in platelets. Recent articles published in Transfusion, the journal of the AABB, indicate that current culture testing methods fail to detect half of the contaminated units in the U.S. inventory and false negative results associated with this testing have resulted in 26 documented septic transfusion reactions including 5 fatalities since testing began in 2004. The Platelet PGD test is designed to allow testing after platelets have entered the inventory and offers clinicians the opportunity to detect contaminated units that slip past current testing methodologies.
"We are thrilled to achieve this critical milestone," said Jim
Lousararian, chief executive officer of Verax Biomedical. "The increasing
recognition of culture false negative results associated with current
platelet testing clearly illustrates the nee
|SOURCE Verax Biomedical Inc.|
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