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FDA Approves Apheresis Platelet Claims for Immunetics’ BacTx Rapid Test for Bacterial Contamination

Immunetics, Inc., a leading clinical test provider, has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacteria in apheresis platelets. The BacTx system is a colorimetric assay that can detect aerobic, anaerobic, gram-negative and gram-positive bacteria in a single test.

“The FDA clearance of BacTx as a point-of-issue assay, initially for whole-blood derived and now for apheresis platelets, represents an additional tool for transfusion services to further reduce the risk of transfusion of bacterially contaminated platelets,” said Dr. Michael Jacobs, director of clinical microbiology, University Hospitals Case Medical Center.

The BacTx assay combines high sensitivity with simple, easy workflow integration. It utilizes a patented, highly specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. BacTx is intended for use as a point-of-issue test performed at the transfusion site on the day of issue.

“Bacterial contamination of platelets represents the greatest infectious risk to patients in transfusion medicine. It is a worldwide problem that has not been satisfactorily solved and puts transfusion patients — particularly those most vulnerable to disease — at greater risk of serious illness or death from a contaminated platelet transfusion,” said John Yonkin, CEO of Immunetics. “We are proud to have developed a novel technology that brings a more sensitive and effective test to the market to help reduce patient risk.”

The BacTx assay can be used for quality control testing of leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, following testing with an FDA-cleared growth-based bacterial detection device. Pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within 4 hours of transfusion.

Immunetics has an established record of developing unique diagnostic tests and products to solve complex problems in infectious disease. "FDA clearance is a major step in bringing BacTx technology to the marketplace,” said Yonkin. “We are now fully committed to rapid commercial development of BacTx for the improvement of transfusion safety both in the U.S. and in markets around the world, and will be shipping our new product by year-end.”

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