Verax Biomedical's Platelet PGD test
This article was originally published in The Gray Sheet
First rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood gains FDA market go-ahead Nov. 13. Bacterial contamination of platelets "is the leading infectious cause of patient fatalities associated with platelet transfusions," according to Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "A rapid test for pooled platelets is an important step in improving safety for patients who are transfused with platelets," Midthun said. The test uses a single-use strip to indicate the presence of bacteria in less than 60 minutes. Clinical studies showed that the test "improved the sensitivity for detecting bacterial levels by 100- to 1,000-fold over existing methods used to test pooled platelets prior to transfusion," FDA says. Fenwal is the exclusive global distributor of the test, which was developed by Verax
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