FDA provides marketing clearance for the Platelet PGD Test System

Nov 16 2009

FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets

The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.

Platelets are used to prevent or treat bleeding in individuals with dangerously low platelet counts, including those undergoing chemotherapy for cancer, following major trauma, during or after surgery, and in individuals who do not produce adequate numbers of platelets. Platelets have the potential to be contaminated with bacteria and it is important to detect and interdict such contamination before transfusion.  Patients who are transfused with contaminated platelets are at risk of developing serious and potentially life-threatening infections.

The Platelet PGD Test System consists of a single-use test strip that, in fewer than 60 minutes, produces a signal that indicates the presence of bacteria.  The test is intended for use mainly by hospital transfusion services as a quality control test for the detection of bacteria after platelets derived from whole blood have been pooled, just prior to a patient  blood transfusion.

"Bacterial contamination of platelets is the leading infectious cause of patient fatalities associated with platelet transfusions," said Karen Midthun, M.D., acting director of the 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."

Clinical studies showed that the Platelet PGD Test System improved the sensitivity for detecting bacterial levels by 100 to 1000-fold over existing methods used to test pooled platelets prior to transfusion.

The Platelet PGD Test System is manufactured by Verax Biomedical, in Worcester, Mass.