GEN Exclusives

More »

GEN News Highlights

More »
Jun 13, 2012

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. 


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Climate Change and Disease

Are the incursions of dengue fever and West Nile virus into North America just the tip of the iceberg of insect-borne diseases that are migrating due to a warming planet?