FDA Clears Immunetics' Rapid Test for Bacterial Contamination of Platelet Units

FDA cleared Immunetics’ BacTx® test for detecting bacterial contamination in donated platelets. The assay is used to test leukocyte-reduced whole blood-derived platelet units to detect contamination by clinically relevant species. The firm says that unlike existing culturing-based approaches that can take days, the BacTx test generates results in less than one hour, and can detect contamination at levels below those shown to be harmful to transfusion recipients. Additional trials are ongoing to expand the potential range of applications for the test. Commercialization of the technology for platelet screening has been supported in part by a $500,000 Massachusetts Life Sciences Center Small Business Matching Grant (SBMG), awarded to the firm just over a year ago.

Immunetics is developing assay technology for infectious disease diagnosis and blood screening. The firm has already achieved FDA approval of a C6 peptide ELISA for Lyme disease, and its Anthrax QuickELISA test, which is the first FDA-approved blood test for anthrax infection. Immunetics' product portfolio in addition includes the QualiCode line of Western blot assay for infectious diseases; the Miniblotter™ instrument for Western blot, spoligotyping (spacer oligonucleotide typing), and other multiprobe membrane assays; and a cell adhesion flow chamber for cell-cell interaction studies.

With NIH funding the firm is continuing to work in collaboration with academic and medical institutions to develop a QuickELISA test for SARS, a Chagas disease confirmatory test, and a test for detecting and identifying drug-resistant bacteria including MRSA and VRE in blood and respiratory samples.