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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 Lives1
Woburn, MA, U.S.A. - October 22, 2008 - AdvanDx today announced that a
new medical study demonstrated use of AdvanDx's PNA FISH™ 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 University of Maryland 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, University of
Maryland Medical Center and lead author of the study.
"We are very excited to see the results from the University of
Maryland 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.
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