Immunetics, Inc., has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacterial contamination in platelet units, Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director, announced today.
Immunetics' BacTx rapid test addresses the greatest infectious risk in transfusion today. An estimated 1 in 2,000 platelet units is contaminated with bacteria — and medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients.
The FDA clearance allows use of the BacTx test on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to the FDA, the BacTx test detected all of the bacterial strains tested, with sensitivity and specificity meeting or exceeding clinical requirements.
"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," Dr. Levin noted.
"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," he said.
With the FDA clearance, the BacTx test is now available for immediate evaluation and sale. Additional trials are underway to expand the range of applications for the test.
"Receiving FDA clearance for the BacTx test is a critical milestone for Immunetics," Levin said, "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."
Comprehensive analysis of more than 2 million SARS-CoV-2 samples detects co-infections and intra-host recombination