AdvanDx adds Enterococcal Bacteremia assay to U.S. and E.U. commercial launch of QuickFISHTM (20 Min. Pathogen ID) Platform

WOBURN, Mass. --(Business Wire)--

AdvanDx, Inc. today announced the commercial launch of Enterococcus QuickFISH BC, a new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Enterococcus. This new QuickFISH assay is immediately available and complements the September 2012 launch of Staphylococcus QuickFISH BC for the identification of Staphylococcus aureus and coagulase-negative staphylococci. With these new products, QuickFISH can now be used to identify the causative pathogens of approximately 70% (Ann Clin Microbiol Antimicrob. 2004 May 10;3:7) of hospital acquired infections from blood cultures.

Enterococcus species are the fourth most common cause of hospital-acquired bacteremia in the U.S. and fifth most common in Europe. The vast majority of enteroccocal infections are caused by Enterococcus faecalis and Enterococcus faecium. Treatment decisions are difficult because these species exhibit differing antibiotic resistance profiles. While E. faecalis is generally susceptible to ampicillin, infections caused by other enterococci, mainly E. faecium, are often resistant to ampicillin or vancomycin, or both. Conventional identification methods can take up to 3 days or longer, and patients withE. faecium bloodstream infections often receive inappropriate antimicrobial therapy for days, leading to higher mortality and significant hospital costs. With this new test, clinicians may prescribe earlier and more appropriate therapy for enterococcal infections. 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.

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 Minute Hands-on Time - Simplifies and streamlines laboratory workflow.

• 20 Minute 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.

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 witin half an hour of receiving a positive blood culture." said Jim Coull, Ph.D, Chief Technology Officer for AdvanDx. "Until this year, 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 and when combined with a sound antimicrobial stewardship program, will provide the quickest and most appropriate therapy for the patient."

As noted in an article by Debra A. Goff, PharmD, FCCP in the August issue of Pharmacy Practice News, "During the past decade, the prevalence of ASPs (antimicrobial stewardship programs) at US hospitals has greatly increased, and the state of California now mandates that general acute care hospitals develop a program to evaluate the judicious use of antibiotics. Additionally, the Infectious Diseases Society of America (IDSA) has made recommendations to the Centers for Medicare & Medicaid Services (CMS) to require stewardship in all acute care hospitals in the United States as part of infection control." It goes on to state "The goal of antimicrobial stewardship is to optimize antimicrobial therapy for improved patient outcomes, with maximal effect on subsequent development of resistance". AdvanDx believes QuickFISH, when combined with stewardship, can provide the most accurate and timely therapy to assist with meeting the above goals.

QuickFISH assays for use with gram-negative rods and Candida species from positive blood cultures are currently in development for launch in 2013 following regulatory approval. AdvanDx has submitted the 510(k) application for the thirdQuickFISH assay for rapid identification of Escherichia coli, Klebsiella pneumonia, and Pseudomonas aeruginosa from gram-negative pathogen blood cultures. AdvanDx believes these products will provide continued opportunities for health care providers to work together to improve patient care and reduce overall healthcare costs in the United States and Europe.

About AdvanDx

AdvanDx is a leading provider of rapid and accurate molecular diagnostic tests for identification of pathogens that cause critical infections in hospitalized patients. Our mission is to improve antibiotic decision-making and patient outcomes while limiting unnecessary and inappropriate antibiotic use and reducing healthcare costs.

AdvanDx employs a unique, Whole Cell Analysis (WCA) approach to pathogen identification using our proprietary Peptide Nucleic Acid Fluorescence In Situ Hybridization (PNA FISH®) technology platform. This technology enables fast and highly accurate single cell analysis for bacterial species identification in samples from patients with critical infections.

AdvanDx is the market leader in molecular testing of positive blood cultures enabling clinical microbiology labs to report pathogen identification results 48 to 72 hours earlier than with conventional testing methods. When used by physicians and pharmacists to ensure early, appropriate antibiotic therapy for patients with bloodstream infections, including septicemia, AdvanDx's PNA FISH tests have been shown in clinical studies to reduce mortality rates, shorten the length of hospital stay, and lower hospital costs.

About Critical Values

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 withStaphylococcus 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.

For more information visit www.AdvanDx.com

References:

1. Herzke, et al. Empirical antimicrobial therapy for bloodstream infection due to methicillin-resistant Staphylococcus aureus: no better than a coin toss. Infection Control and Hospital Epidemiology, 2009, 30:1057. http://www.ncbi.nlm.nih.gov/pubmed/19803766

2. Kumar A., Roberts D., Wood Ke. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical Care Med. 2006;34(6):1589-96. http://www.ncbi.nlm.nih.gov/pubmed/16625125