Verax Biomedical Receives Clearance From FDA For Platelet PGD Test
Platelet PGD Test
Verax Biomedical has received 510 (k) clearance for its Platelet PGD Test System from 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 need for a rapid test like Platelet PGD. With our ability to enable testing later in platelet unit life, after bacteria have had a chance to grow, blood bankers will have access to a critical new tool in the battle against bacterial contamination."
The Platelet PGD Test is an easy-to-use, disposable device designed to detect the presence of a broad range of bacterial contaminants in platelets at a later phase in platelet unit life than current culture methods. Bacterial contamination in platelets and red blood cells represents the single greatest risk for lethal infections in transfusion medicine today. An estimated 10 million platelet units are transfused each year into patients in North America, Europe and Asia, and experts estimate that as many as 1 in every 2,000 units are contaminated with bacteria.
The Verax PGD Test is based on Verax Biomedical's proprietary Pan Genera(R) Detection technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.