Gram-Negative QuickFISH Blood Culture Assay Allows Identification & Treatment of Sepsis in 20 Minutes

AdvanDx, Inc., a leading provider of molecular diagnostic tests for identification of pathogens that cause critical infections in hospitalized patients, has announced 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. Today’s announcement of the commercial launch of Gram-Negative QuickFISH BC adds to AdvanDx’s two gram-positive QuickFISH tests: StaphylococcusQuickFISH BC for the identification of Staphylococcus aureus and/or coagulase-negative staphylococci; and EnterococcusQuickFISH BC, for the identification of Enterococcus faecalis and/or selected other enterococci. AdvanDx anticipates commercial launch of the fourth QuickFISH assay for identification of Candida 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 now QuickFISH 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.

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. 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.