AdvanDx, Inc. Announces U.S. and E.U. Commercial Launch of QuickFISH (20 Min. Pathogen ID), the First Molecular Test to Enable Reporting of Pathogen Identification at the Time of Gram Stain Results From Positive Blood Cultures
9/10/2012 9:29:48 AM
WOBURN, Mass.--(BUSINESS WIRE)--AdvanDx, Inc. today announced the commercial launch of QuickFISH™, a new rapid pathogen identification test for potential life threatening bloodstream infections. QuickFISH will be available beginning September 24th. QuickFISH marks a significant advance in time-to-result and ease-of-use that will help clinicians, hospital pharmacists and clinical microbiologists optimize antibiotic therapy much earlier for patients with bloodstream infections, including septicemia, caused by dangerous bacterial pathogens including Staphylococcus aureus and coagulase-negative staphylococci. AdvanDx received 510(k) clearance from the U.S. Food and Drug Administration on April 3, 2012 and completed the CE mark requirements as part of the launch process with their U.S. and European Union commercial organizations. Additional QuickFISH assays for identification of other clinically important microbial species are currently in development for launch in 2012 and 2013 and will provide continued opportunities for AdvanDx and health care providers to work together to improve patient care and reduce overall healthcare costs in the United States and Europe.