FDA Approved Expanded Indication of Marketing Clearance for Verax PGD Test
Massachusetts–based Verax Biomedical has received expanded FDA marketing clearance for its Platelet PGD Test to include use for single units of leuko-reduced or non leuko-reduced whole blood derived platelets in plasma.
The test is FDA cleared for testing post storage pools of up to six leuko-reduced or non leuko-reduced WBD platelets in plasma.
The device is also 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.
The device only has to be run once on a platelet dose before it is transfused to reduce the risk of sepsis caused by bacterial contamination.