Immunetics’ QuickELISA™ Anthrax-PA Kit First to Win FDA Approval for In Vitro Diagnosis of Anthrax

CDC collaboration yields new anthrax test

BOSTON, Mass.....June 25, 2004…..Immunetics has received clearance from the U.S. Food and Drug Administration for the first ELISA kit for in vitro diagnosis of anthrax.  This CE-marked kit provides labs with a simple and rapid means to confirm anthrax infection in a potential bioterrorism incident or in cases of natural exposure.  The QuickELISA Anthrax-PA kit detects antibodies to the Protective Antigen of B. anthracis.  In clinical trials, the test detected 100% of the patients with confirmed inhalational or cutaneous anthrax.  The false positive rate was less than 1% in control populations.  The kit can also be used to monitor antibodies generated in response to vaccination against anthrax with PA-based vaccines.  The QuickELISA kit includes a 96-well breakaway microplate, all reagents and controls in ready-to-use format.  The turnaround time for the assay is about 45 minutes from start to finish, after which results are read on a standard microplate reader.  The kit detects antibodies of all isotypes in human as well as non-human species.  Based on Immunetics’ QuickELISA chemistry, it simplifies the procedure and yields higher sensitivity and specificity than conventional ELISA methods.