AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe

WOBURN, Massachusetts and VEDBAEK, Denmark - Pathogen Identification Results in 90 Minutes Direct from Positive Blood Cultures

- Faster Results to Help Clinicians Improve Antibiotic Selection and Outcomes for Critical Infections

AdvanDx today announced that it has launched a fast, 90 minutes protocol for all CE-IVD marked PNA FISH(R) tests in Europe. The fast protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization time from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the United States and Europe show the two protocols to be 100% equivalent while maintaining the very high (>95%) sensitivity and specificity versus slower, conventional laboratory methods.

Since the first product launch in May 2003, AdvanDx’s PNA FISH tests have provided rapid identification of bloodstream pathogens to help clinicians optimize antibiotic therapy and improve care for patients with critical infections. Clinical studies have shown that implementing PNA FISH tests reduced time to reporting of pathogen identification results by up to 48-72 hours, improved antibiotic selection for patients with bloodstream infections, reduced unnecessary antibiotic use, reduced infection related mortality rates and significantly reduced hospital bed, pharmacy and laboratory costs. (1,2,3,4) With the shortened protocol, labs will be able to provide results even faster to help clinicians further improve antibiotic prescribing and patient care.

“We are very excited to launch the shortened PNA FISH protocol in Europe,” said Thais T. Johansen, President and CEO of AdvanDx. “The faster results will enable laboratories to provide this critical information sooner to clinicians, enabling them to make the most appropriate antibiotic selection and treatment decision as early as possible,” Johansen concluded.

PNA FISH Diagnostic Platform Features: - Standard protocol with 90 min. Turn-around Time and minimal Hands-on Time - Close to 100% sensitivity and specificity versus conventional, slower laboratory methods - Molecular method requiring only a fluorescence microscope to get started - Identification of staphylococci, enterococci, Gram-Negative bacteria and Candida species directly from positive blood cultures - Fast and actionable results for 95-99% of all patients with bloodstream infections and positive blood cultures - Cost/Benefit and outcomes studies proving clinical utility of faster results

About PNA FISH(R)

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 www.AdvanDx.com

References 1. Ther Clin Risk Manag. 2008 Jun;4(3):637-40 2. Antimicrob Agents Chemother. 2008 Oct;52(10):3558-63 3. Poster P1382. ECCMID 2008, Barcelona, Spain 4. J Clin Microbiol. 2006 Sep;44(9):3381-3

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Source: AdvanDx

Joen T. Johansen, Director of Marketing for AdvanDx, +1-339-227-4052, jtj at advandx.com