A Medical Device Daily
Immunetics (Boston), which offers assay technology for infectious disease diagnosis and pathogen detection, has received a $2.5 million grant from the National Heart, Lung and Blood Institute (NHLBI) to support clinical trials for its BacTx test for bacterial contamination of platelet units.
The award is a continuation of earlier grants from the National Institutes of Health that supported the development of the test. The NIH grant is intended to help the company obtain FDA approval and bring the product to market. Transfusion of bacterially contaminated platelets can result in severe or fatal sepsis, and remains the highest known risk associated with transfusion of blood products, the company said.
Screening all platelet units for bacterial contamination has recently been mandated by the American Association of Blood Banks (AABB; Washington), but rapid tests are not yet available for this purpose.
Immunetics said that the test detects bacteria of all types in a “simple and rapid procedure.” The clinical trials will be conducted at several major medical centers, following which the company plans to seek regulatory approval of the test.
“We are extremely pleased to receive the generous support of the National Heart, Lung and Blood Institute for the clinical trial of our BacTx test for bacterial contamination of platelets, which we believe will make a significant difference in transfusion safety” said Andrew Levin, founder and CEO of Immunetics.
“The BacTx test will meet a well-recognized need in hospitals and blood centers. It will enable blood banks and transfusion clinics to test for bacteria before a platelet unit is transfused, rather than waiting several days for culture results or testing with less accurate methods. Everyone including patients and blood centers stands to gain from using this test.”