- New Rapid Pathogen ID System Launched to Identify Life Threatening Infections
Product News: New Rapid Pathogen ID System Launched to Identify Life Threatening InfectionsThe molecular diagnostic company AdvanDx, Inc. has just announced the commercial launch of QuickFISH™, a new rapid pathogen identification test for potential life threatening bloodstream infections.
QuickFISH is a new, rapid, molecular diagnostic platform developed by AdvanDx based on its clinically proven proprietary PNA technology. The new platform enables unprecedented (20 minute) species identification of bacteria directly from positive blood cultures allowing the reporting of pathogen identification at the same time as the reporting of Gram stain results.
The platform 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.
“QuickFISH is an innovation that will revolutionize antimicrobial therapy. It provides valuable information rapidly, enabling the prescriber to provide effective antimicrobial therapy more quickly to patients with bloodstream infections, which will help to save lives, decrease the number of hospital days for our patients and allow for cost savings and improve other clinical outcomes,” said Dr. Keith S. Kaye, M.D., M.P.H., Professor of Medicine and Corporate Medical Director, Infection Prevention, Epidemiology and Antimicrobial Stewardship, Detroit Medical Center and Wayne State University.
AdvanDx believes the speed and ease-of-use of QuickFISH within the microbiology lab will provide positive clinical and financial benefit to patients, health care providers and institutions by enabling more targeted antibiotic therapy.