AdvanDx's PNA FISH Test Shown to Reduce Mortality by 42% for Patients With Hospital-Acquired Enterococcus faecium Bloodstream Infections

Two Days Faster Test Results Enable Physicians to Direct Earlier, Effective Antimicrobial Therapy for Patients with Drug Resistant Hospital-Acquired Infections and Save Lives(1)

WOBURN, Mass., October 22, 2008 /PRNewswire/ -- AdvanDx today announced that a new medical study demonstrated use of AdvanDx's PNA FISH(TM) test reduced mortality by 42% for patients with highly drug resistant Hospital-Acquired Enterococcus faecium bloodstream infections (BSI's). In addition, the study demonstrated that PNA FISH reduced the time to reporting of laboratory identification results for all enterococcal BSI's by 2.6 days and reduced time to appropriate antimicrobial therapy for E. faecium BSI's by 1.8 days. The study was undertaken by clinicians at the Medical Center (UMMC) in Baltimore, Maryland and published in the latest issue of Antimicrobial Agents and Chemotherapy.(1)

Bloodstream infections due to Enterococcus bacteria, predominantly Enterococcus faecalis and E. faecium, are often acquired while patients are in the hospital and can lead to increased mortality, longer hospital stays and increased healthcare costs. The infection is initially diagnosed when a culture of the patient's blood turns positive with Gram-positive cocci in pairs and chains (GPCPC), indicative of enterococci and/or streptococci. Because conventional laboratory identification methods can take 48 hours or longer and early antimicrobial therapy is crucial to ensure positive patient outcomes, physicians often prescribe broad-spectrum antibiotics such as vancomycin to cover the patient. However, this may lead to the administration of inadequate or inappropriate antibiotic treatment as E. faecium is often resistant to both vancomycin (VRE - vancomycin-resistant enterococci) and penicillin-based drugs such as ampicillin while E. faecalis is often susceptible to ampicillin. PNA FISH delivers rapid, molecular identification of E. faecalis and other enterococci, including E. faecium, directly from GPCPC positive blood cultures in hours instead of days. As a result, laboratories can provide faster information that enables clinicians to select effective antibiotic therapy sooner for patients afflicted with enterococcal bloodstream infections.(1)

The study included 224 patients with hospital-acquired enterococcal bloodstream infections; 112 patients before the PNA FISH test was implemented (Pre-PNA FISH group) and 112 after implementation (PNA FISH group). A treatment algorithm based on the rapid PNA FISH results was developed and implemented by the hospital's antimicrobial management team. Patients with E. faecalis by PNA FISH were to be given ampicillin, while patients with other enterococci, including E. faecium, and at "high risk" for VRE were to be given linezoid, a newer anti-VRE antibiotic. At the end of the study, data on characteristics, therapy and outcomes between the Pre-PNA FISH and PNA FISH patients groups were compared.(1)

 

    Significant UMMC Study Data (Pre-PNA FISH vs. PNA FISH Groups)(1)
    -- More than 88% of all E. faecium were resistant to vancomycin (VRE) and
       100% were resistant to ampicillin
    -- 84% of initial empirical antimicrobial therapy for patients with E.
       faecium BSI's was inadequate
    -- 2.6 days reduction in time to laboratory identification results in PNA
       FISH group
    -- 1.8 days reduction in time to appropriate antimicrobial therapy for E.
       faecium in PNA FISH group
    -- 42% reduction in 30-day mortality rates for patients with E. faecium in
       PNA FISH group
    -- PNA FISH Sensitivity, Specificity, Positive Predictive Value and
       Negative Predictive Value shown to be 100% compared to conventional
       methods

"Use of PNA FISH in conjunction with a treatment algorithm led to earlier identification of the Enterococcus species for patients with hospital-acquired enterococcal bloodstream infections and the earlier initiation of effective antimicrobial therapy for patients with hospital-acquired E. faecium bloodstream infections," said Dr. Graeme Forrest, Division of Infectious Diseases, Medical Center and lead author of the study.

"We are very excited to see the results from the Medical Center study. Not only do they show that PNA FISH significantly speeds up species identification results from the lab, but also that using the results to tailor therapy at an earlier stage in bloodstream infections can significantly improve patient care and outcomes," said Thais T. Johansen, President and CEO of AdvanDx. "If we extrapolate the data to the rest of the country, PNA FISH could help ensure that all of the 18,000 patients with hospital-acquired enterococcal bloodstream infections receive effective antibiotic therapy as early as possible and help save close to 2,000 lives. In essence, implementing PNA FISH and providing rapid results to clinicians could be more beneficial than any new antibiotic to treat the infections," Johansen added.

About Bloodstream Infections

Every year, 350,000 patients contract bloodstream infections, causing over 90,000 unnecessary deaths and significant costs to the healthcare system. The infection is detected when a culture of the patient's blood (i.e. a blood culture) turns positive with bacteria and yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

About PNA FISH(TM)

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don't require the extensive sample preparation necessary for other nucleic acid technologies.

PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

About AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnostic products for the prevention, diagnosis and treatment of life-threatening, bacterial infections. AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment to reduce startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Major medical centers, reference labs, government institutions and community hospitals throughout the United States, Europe and Asia rely on AdvanDx products as integral parts of their medical care.

 

    For more information visit http://www.AdvanDx.com

    CONTACTS:
    Company Contact:            Media Inquiries:
    Joen T. Johansen            Joe Romano
    Director of Marketing       Partner
    AdvanDx                     HighGround, Inc.
    +1-339-227-4052             +1-781-939-5800 Ext 208
    jtj@advandx.com             jromano@highgroundinc.com

    References:
    (1)  Forrest et al.  Peptide nucleic acid fluorescent in situ
         hybridization for hospital-acquired enterococcal bacteremia:
         delivering earlier effective antimicrobial therapy.  Antimicrob
         Agents Chemother. 2008 Oct;52(10):3558-63.

CONTACT: Joen T. Johansen, Director of Marketing of AdvanDx,+1-339-227-4052, ; or Joe Romano, Partner, of HighGround,Inc. for AdvanDx, +1-781-939-5800, Ext 208, jtj@advandx.com jromano@highgroundinc.com

Web site: http://www.AdvanDx.com/

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Posted: October 2008

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