10/04/2012

AdvanDx A/S

AdvanDx Announces Commercial Launch of QuickFISH™

AdvanDx to launch QuickFISH (20 Min. Pathogen ID) for life threatening Staphylococcus aureus and/or coagulase-negative staphylococci. Clinicians are now able to optimize therapy with critical values call required by Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Regulations.

Woburn, MA, U.S.A. – September 10, 2012 – 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.

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.

QuickFISH Features:
5 Min. Hands-on Time – Simplifies and streamlines laboratory workflow.
20 Min. Turn-around Time – Fast enough to be reported with Gram stain results.
Built-in, Universal Controls – Ensures confidence in test results.
Limited Instrumentation and Capital Investment Required – Easy and inexpensive to implement and start testing.

“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. “QuickFISH will also improve antibiotic stewardship efforts and decrease inappropriate and unnecessary antibiotic utilization. This in turn will help to improve patient safety and limit antibiotic resistance. At both the level of the individual patient and the healthcare provider, as well as from a public health perspective, QuickFISH is a welcomed innovation that will improve the management of bloodstream infections.”

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. “The unmatched speed and simplicity of the QuickFISH procedure, which allows the laboratory to report pathogen identification to clinicians with the Critical Value Gram stain result, provides a much greater ability to optimize therapy within half an hour of receiving a positive blood culture.” said Jim Coull, Ph.D, Chief Technology Officer for AdvanDx. “Until today, the ability to provide pathogen identification in 20 minutes or less from a positive blood culture was not possible. QuickFISH is specifically designed to address laboratory workflow needs while assuring that clinicians receive the critical information that enables them to best optimize antibiotic therapy. We believe QuickFISH is a major advance for patients and their health care providers.”

Critical Values are laboratory results that indicate a condition likely to have significant medical implications for the patient requiring immediate clinical intervention. As outlined in the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) guidelines, the communication of Critical Values to a health care provider must be performed immediately. At most U.S. healthcare facilities, the Gram stain Critical Value for a positive blood culture is required to be reported and receipt confirmed by the clinician within one hour of the blood culture turning positive. Today, nearly half of patients with Staphylococcus aureus bloodstream infections receive suboptimal therapy(1) exposing them to an increased risk of death as well as higher costs of treatment and/or duration of hospital stay. Delay in administration of appropriate antibiotics is associated with a 7.6% decrease in the survival rate of patients for each hour therapy is delayed.(2) Given the life threatening nature of bloodstream infections, QuickFISH, for the first time, allows clinicians, laboratory technicians and pharmacists, to work together to provide better targeted therapy, more quickly than has previously been possible with other molecular diagnostics tests and conventional methods of pathogen identification.