Navigation Links
AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
Date:12/10/2009

WOBURN, Mass., and VEDBAEK, Denmark, Dec. 10 /PRNewswire/ -- AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its S. aureus PNA FISH® and S. aureus/CNS PNA FISH® tests. 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 demonstrated excellent 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.

Staphylococcus species are both the most frequent causes of bloodstream infections (BSI) and blood culture contamination. True infections caused by Staphylococcus aureus present considerable clinical challenges associated with increased mortality rates, prolonged hospital stays and add significant extra hospital costs.(1) In the United States alone, 300,000 hospitalized patients contract a S. aureus infection leading to more than 12,000 deaths, 2.7 million excess LOS days and close to $9.5 billion in excess hospital charges.(2) Blood culture contamination with Coagulase-Negative Staphylococci (CNS) on the other hand, account for up to 30% of all positive blood cultures and often result in a false diagnosis of a true staphylococcal bloodstream infection that leads to unnecessary coverage with broad-spectrum antibiotics, extra length of stay and unnecessary extra costs. As conventional identification methods can take several days to differentiate between true infection and contamination, clinicians must rely on empiric therapy which may result in either unnecessary or inadequate treatment.

Since 2003, the use of PNA FISH for rapid identification of staphylococcal bloodstream pathogens has drastically improved therapy decisions and outcomes for patients with bloodstream infections by providing results in hours, instead of days to help physicians and pharmacists optimize antibiotic therapy earlier. A clinical study performed at the Washington Hospital Center (Washington, D.C.) demonstrated that rapid identification and notification of PNA FISH results reduced ICU and overall mortality rates by 82% and 53% respectively, while reducing antibiotic use for patients with CNS positive blood cultures. In a separate study performed at the University of Maryland Medical Center (Baltimore, MD) rapid PNA FISH results, helped reduce unnecessary vancomycin use by 4.5 doses, length of stay by 2 days and hospital costs by $4,005 for patients with CNS contaminated blood cultures.(1,3)

With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve turn-around times for critical results and thereby help clinicians further improve antibiotic selection, care, and outcomes for patients with staphylococcal bloodstream infections.

"We are extremely pleased with the latest FDA clearances for the faster PNA FISH protocols for S. aureus and Coagulase-Negative Staph," said Thais T. Johansen, President and CEO of AdvanDx. "Staphylococci present significant challenges for managing patient care and controlling hospital costs. With fast PNA FISH results, hospitals have a tool to help both improve patient care and reduce unnecessary costs," 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

S. aureus PNA FISH® and S. aureus/CNS PNA FISH® are distributed by bioMerieux, Inc. in the United States.

References

1. Ly et al. Ther Clin Risk Manag. 2008 Jun;4(3):637-40.

2. Noskin et al. Arch Intern Med. 2005 Aug 8-22;165(15):1756-61.

3. J Antimicrob Chemother. 2006 Jul;58(1):154-8.

PN1715A

SOURCE AdvanDx


'/>"/>
SOURCE AdvanDx
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe
2. Study Shows Use of AdvanDxs PNA FISH(TM) Test was Associated with an 82% Reduction in Intensive Care Unit Mortality Rates from Staphylococcus aureus Bloodstream Infections
3. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
4. Masimo Receives 2009 Zenith Award at the American Association of Respiratory Care Congress
5. SRI International Receives National Institutes of Health Grants to Develop Improved Tomographic Imaging Technology
6. Giant Eagle(R) Pharmacy Receives Award for Operational Excellence
7. Veran Medical Receives FDA Clearance to Market Electromagnetic Navigated Bronchoscopy Product: The SPiN Drive(TM) System
8. AMP Receives $1.4 Million Grant From the Bill & Melinda Gates Foundation to Improve Advocacy for VACCINES and Immunization Systems in West Africa
9. HealthSport, Inc. Closes Stock Purchase Agreement With SMI Manufacturing - Receives $2.5 Million
10. Northwest Biotherapeutics Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax(R) Manufacturing
11. Pioneer(R) Surgical Technology, Inc. Receives Prestigious Spine Technology Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... -- TapImmune,Inc. (TPIV), a clinical-stage immune-oncology ... immunotherapeutics and vaccines for the treatment of cancer & metastatic ... Annual Growth Capital Expo to be held on May ... Palace in Las Vegas, Nevada.  The Company presentation will ... by Dr. John N. Bonfiglio a TapImmune ...
(Date:4/27/2016)... 2016 Im ... Zürich gab Strekin AG den Start einer ... Erhaltung des Resthörvermögens von Patienten, denen ein ... umfassende Phase-II-Doppelblindstudie mit Placebo-Kontrollgruppe werden momentan Patienten ... während der Operation direkt ins Mittelohr verabreicht. ...
(Date:4/27/2016)... -- Elekta today announced that its leading-edge ... focal point of seven scientific presentations at ESTRO 35, ... & Oncology, taking place April 29 - May 3. ... and a high-field MRI scanner with sophisticated software that ... in real time. The MR-linac is designed to improve ...
Breaking Medicine Technology:
(Date:5/2/2016)... ... May 02, 2016 , ... It has just been announced ... for five events throughout the month of May. , Uldrich is the author of ... outlets. He also frequently appears on the Science Channel’s FutureScape and Discovery Channel’s Inside ...
(Date:5/2/2016)... (PRWEB) , ... May 02, 2016 , ... ... Issue 1 of Patient Experience Journal (PXJ), an international, open access, peer-reviewed ... With almost half the issue representing international (non-US) based authors, the third volume ...
(Date:5/2/2016)... ... 02, 2016 , ... Beanfields, PBC, makers of Beanfields Bean ... students at University of Colorado in Boulder to create new advertising campaigns. , ... the School of Journalism, who selected Beanfields as the brand on which to ...
(Date:5/2/2016)... ... 2016 , ... Amica Life Insurance Company has unveiled ... various life stages. , The site launched on April 1, and it has ... to the times when life insurance matters most. , “Through our research, we ...
(Date:5/2/2016)... ... 2016 , ... The National Resident Matching Program® (NRMP®) has ... Match”), the system through which U.S. and international medical school students and graduates ... placed in the 2016 Match, and 29,572 were filled when the matching algorithm ...
Breaking Medicine News(10 mins):