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."