The Verax Platelet PGD test is the first test cleared by the FDA as a Safety Measure within 24 hours of transfusion of leukoreduced apheresis platelets that have been tested by a growth-based QC method cleared by the FDA for platelet components. It is sensitive, simple, rapid and practical for use in the hospital transfusion service setting, providing results in approximately 30 minutes.
By testing closer to the time of transfusion, the Platelet PGD Test offers the opportunity to detect and prevent the transfusion of bacterially contaminated platelet units that test falsely negative by existing QC testing methods. It is the first FDA cleared method for testing on the day of transfusion, offering the opportunity to address this significant risk to patient safety.
The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.