Immunetics Announces FDA Clearance for Platelet Bacterial Contamination Test

Immunetics, Inc., has received U.S. Food and Drug Administration (FDA) clearance for its BacTx^® rapid test for bacterial contamination in platelet units. 1 in 2,000 platelet units is estimated to be contaminated with bacteria which can cause significant illness and even 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,” notes Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific DirectorDr.

“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.”

The results of clinical trials of the BacTx test were presented by Drs. Andrew Heaton (NSLIJ Health System, New York) and Michael Jacobs (University Hospital - Case Medical Center, Cleveland), the clinical investigators leading the trials, at the American Association of Blood Banks (AABB) meeting in October 2011.

Immunetics has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply.