MARLBOROUGH, Mass.--(BUSINESS WIRE)--Expanding its range of FDA-cleared indications for use, the FDA granted a new clearance for the Verax Platelet PGD® Test when applied to single units of leukoreduced or non-leukoreduced whole blood derived (WBD) platelets in plasma. The test is already FDA cleared for testing post storage pools of up to six (6) leukoreduced or non-leukoreduced WBD platelets in plasma.
Individual units of WBD platelets are often used as pediatric doses in U.S. hospitals. This new clearance helps reduce the risk of bacterial contamination for a patient population of particular concern to all health care professionals.
"This new claim expands our existing portfolio of FDA clearances for the Platelet PGD® Test," said Jim Lousararian, Verax Chief Executive Officer. "It has been requested by current users of PGD as well as being outlined as a need in pending FDA Draft Guidance to address the risk of bacterial contamination in platelets."
The Verax PGD® test is already FDA cleared as a Safety Measure for bacterial contamination in platelets, meaning it can also be used to extend platelet dating to 7 days when testing apheresis platelets in plasma.
"Pediatric patients pose unique challenges in transfusion medicine," said Paul Mintz, MD, Chief Medical Officer of Verax. "They require small platelet doses and possess fragile immune systems. PGD testing individual WBD units for transfusion makes it practical to provide bacterially tested platelets to this most vulnerable group of patients."
Verax's patented Pan Genera Detection (PGD) technology is ideally suited to address the need for rapid and practical tests for bacterial contamination, due to its unique and proven ability to detect a wide variety of possible bacterial contaminants quickly, cost effectively and with minimal labor. The PGD® test only has to be run once on a platelet dose before it is transfused to reduce the risk of sepsis caused by bacterial contamination. It is the most cost effective method of addressing bacterial risk and is the fastest and least labor-intensive way to test for platelet bacterial contamination on the market today.
About Verax Biomedical
Verax Biomedical is the producer of the Platelet PGD® Test, the only test for bacterial contamination in platelets granted a Safety Measure claim by the FDA. The test can be used to extend the dating of apheresis platelets in plasma, the most common platelet type transfused in the U.S., from 5 to 7 days. This dating extension offers the opportunity for significant cost savings to the hospital and blood banking community while preserving a critical life giving resource. For more information, visit http://veraxbiomedical.com/.