The US Food and Drug Administration (FDA) has approved Immunetics' BacTx rapid test to detect bacterial contamination in platelet units.
The clearance allows BacTx test to use on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which shows bacterial contamination due to the pooling of units from multiple donors.
In the studies reported to the FDA, the BacTx test has detected all the bacterial strains used in the trial.
The company reported that additional trials are underway to expand the range of applications for the test.
Immunetics chief executive officer and scientific director Andrew Levin said the BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient.
"Culminating years of work in which we've taken a novel technology from concept through clinical trials and regulatory approval -- and are now ready to address an urgent need in the blood bank and transfusion services market," Levin added.
