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AdvanDx, Inc. Adds Gram-Negative BC Assay to U.S. and E.U. Commercial Launch of QuickFISH(TM) - a 20 Min. Pathogen ID Platform for the Identification & Treatment of Sepsis


8/14/2013 9:24:39 AM

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Woburn, MA, U.S.A. – September 23, 2013 – AdvanDx, Inc., a leading provider of molecular diagnostic tests for identification of pathogens that cause critical infections in hospitalized patients, announces the commercial launch of Gram-Negative QuickFISH BC. Gram-Negative QuickFISH BC is a new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Escherichia coli, and/or Pseudomonas aeruginosa and/or Klebsiella pneumoniae, within 20 minutes of a positive blood culture, making it the fastest method of identifying gram-negative species in positive blood cultures on the market today.

The new gram-negative assay is immediately available and further expands AdvanDx’s QuickFISH Platform that can now identify the pathogens responsible for 90% of positive blood cultures.1 Today’s announcement of the commercial launch of Gram-Negative QuickFISH BC adds to AdvanDx’s two gram-positive QuickFISH tests:Staphylococcus QuickFISH BC for the identification of Staphylococcus aureus and/or coagulase-negative staphylococci; and Enterococcus QuickFISH BC, for the identification of Enterococcus faecalis and/or selected other enterococci. AdvanDx anticipates commercial launch of the fourth QuickFISH assay for identification ofCandida species from positive blood cultures in the second half of 2013, following regulatory clearance.

“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 an unprecedented ability to optimize therapy within half an hour of receiving a positive blood culture,” said Jim Coull, Ph.D, Chief Technology Officer for AdvanDx. “Before QuickFISH, clinicians did not have the ability to know which species of pathogen was responsible for a positive blood culture at the time they received the initial Gram Stain results, but nowQuickFISH can provide rapid pathogen identification that enables them to better optimize antibiotic therapy.QuickFISH is also specifically designed to address laboratory workflow needs by providing microbiology technologists an easy to use 20 minute test with less than five minutes of hands on time.”

Gram-negative bloodstream infections, especially those caused by Pseudomonas aeruginosa, are associated with high mortality rates and can be difficult to treat due to increasing resistance to antimicrobial agents. Traditional laboratory testing methods take 24 to 48 hours or longer to identify the causative pathogen, forcing clinicians to treat patients based on limited information. This presents a challenge for the health care provider as the decision to add an anti-pseudomonal drug should ideally be based primarily on knowledge of the infecting species. As a result, patients with gram-negative bloodstream infections are often either subjected to broader than necessary antimicrobial therapies, which may be toxic and may promote the development of drug resistance, or they may be undertreated, increasing their risk for adverse outcomes.

QuickFISH Features

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.

• 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.

About Antimicrobial Stewardship

Gram-Negative QuickFISH BC empowers clinicians with information that helps them prescribe earlier, targeted therapy for gram-negative pathogens and potentially improve mortality rates and patient survival.2 QuickFISH, when combined with antibiotic stewardship programs, can provide the most accurate and timely therapy to assist hospitals in meeting the goals of organizations like the New York Department of Health, the State of California and the IDSA.

An article authored by Debra A. Goff, PharmD, FCCP in the August 2012 issue of Pharmacy Practice News, highlighted the potential benefit of these types of efforts when combined with effective institutional stewardship. “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.” The article goes on to state that “the goal of antimicrobial stewardship is to optimize antimicrobial therapy for improved patient outcomes, with maximal effect on subsequent development of resistance.”3

About AdvanDx, Inc.

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.

We employ a unique, whole cell analysis 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 and fungal 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.4 For more information, visitwww.AdvanDx.com

CONTACT:

Jeff Moyer, VP of Sales & Marketing

AdvanDx, Inc.

400 TradeCenter

Woburn, MA 01801

United States

Tel: +1-866-376-0009

REFERENCES:

1 Ann Clin Microbiol Antimicrob. 2004 May 10;3:7.

2 Crit. Care Med. 2006, 34:1589-1596.

3 Pharm Prac News 2012 August;Spec Edi:45-56.

4 J Antimicrob Chemother. 2006 Jul;58(1):154-8.

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