The U.S. Food and Drug Administration (FDA) has cleared Immunetics Incorporation's BacTx rapid test used to detect bacterial contamination in platelet units.
The clearance allows BacTx test use on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which shows bacterial contamination.
In the studies reported to the FDA, the BacTx test has detected all the bacterial strains used in the trial.
Immunetics Chief Executive Officer and Scientific Director Andrew Levin said existing approaches to the detection of bacterial contamination have fallen short, leaving patients at risk.
"They rely mainly on the culturing of the platelet units, a decades-old method that takes up to several days to yield a result,"Levin added.
"By contrast,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."
