AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for
Identifying Enterococcal Bloodstream Pathogens
Pathogen Identification Results in 90 Minutes Direct from Positive Blood
Cultures
WOBURN, Mass. and VEDBAEK, Denmark, Oct. 27 /PRNewswire/ -- AdvanDx today
announced that it has received FDA 510(k) clearance for a fast, 90 minutes
protocol for its E. faecalis/OE PNA FISH(®) test. The faster protocol reduces
the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by
reducing PNA probe hybridization from 90 minutes to 30 minutes. Clinical
validation studies performed at hospitals in the United States and Europe
demonstrated 100% equivalence between the 90 minutes protocol and the original
PNA FISH protocol, ensuring the faster protocol maintains the very high
sensitivity and specificity required versus slower, conventional methods.
Enterococcus species cause a significant percentage of bloodstream infections
(BSI) as they are the fourth most common cause of hospital-acquired bacteremia
within the US and the fifth most common in Europe.(1) While infections with E.
faecalis are generally susceptible to ampicillin and rarely resistant to
vancomycin, infections with E. faecium and other enterococci (OE) are
frequently resistant to both ampicillin and vancomycin (VRE -
vancomycin-resistant enterococci). Since conventional identification methods
can take 3 days or longer, up to 80% of VRE bacteremia receive inappropriate
antibiotic therapy, leading to higher mortality and significant additional
hospital costs.( )(2,3,4)
Since 2003, E. faecalis/OE PNA FISH has been a vital test providing species
identification in hours, instead of days, allowing labs to quickly report
results to physicians and pharmacists to help ensure optimal therapy for
Enterococcal bloodstream infections. A recently published clinical study from
the University of Maryland Medical Center demonstrated that the use of E.
faecalis/OE PNA FISH reduced time to laboratory results by 2.6 days, reduced
time to appropriate therapy for E. faecium by 1.8 days and most importantly,
reduced 30 day mortality rates by 42% for patients with E. faecium
bacteremia.(5)
With the introduction of the 90 minutes PNA FISH protocol, laboratories will
be able to further improve workflow flexibility and results reporting
turn-around times. By providing even faster results, laboratories will help
clinicians further improve antibiotic selection, care, and outcomes for
patients with Enterococcal bloodstream infections.
"We are very excited to launch the 90 minutes E. faecalis/OE PNA FISH protocol
in the United States," said Thais T. Johansen, President and CEO of AdvanDx.
"The faster protocol marks another milestone toward AdvanDx's goal of
providing a fast, easy-to-use and broad molecular diagnostic platform for
early identification of bloodstream pathogens. With results in 90 minutes,
hospitals will be able to provide critical results as early as possible,
enabling clinicians to improve care and outcomes for patients with
life-threatening infections," Johansen concluded.
About AdvanDx
AdvanDx is the leading provider of advanced molecular diagnostic products for
the diagnosis and treatment of life-threatening, bloodstream 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 www.AdvanDx.com
E. faecalis/OE PNA FISH(® )is distributed by bioMerieux, Inc. in the United
States.
References
1. Biedenbach et al. Diagn. Microbiol. Infect. Dis. 2004; 50: 59-69.
2. Lodise et al. Clin. Infec. Dis. 2002; 34: 922-929
3. Vergis et al. Ann. Intern. Med. 2001; 135: 484-492
4. Centers for Disease Control and Prevention (CDC). Information for the
public about VRE.
http://www.cdc.gov/ncidod/dhqp/ar_VRE_publicFAQ.html
5. Forrest et al. Antimicrob Agents Chemother. 2008 Oct;52(10):3558-63.
PN1682A
SOURCE AdvanDx
Joen T. Johansen, Director of Marketing of AdvanDx, +1-339-227-4052,
jtj@advandx.com
