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:8/7/2017)... Aug. 7, 2017 Insightin Health, provider ... retention, and engagement, announced the selection of ... Product Development, effective as of February 2017. In this ... implementation strategy for our clients. Wood brings with ... consulting and business analytics within the healthcare industry. ...
(Date:8/7/2017)... DUBLIN , Aug. 7, 2017  Endo International ... has reached agreements to resolve virtually all known U.S. ... in discussions to resolve the known remaining U.S. claims ... installment payments beginning in the fourth quarter of 2017 ... part of its second quarter 2017 results, the Company ...
(Date:8/2/2017)... , Aug. 2, 2017 Fenita ... Who as a Pinnacle Lifetime Professional in the ... Account Manager at Turing Pharmaceuticals, AG. Her skills ... and relationship building.                ... than 25 years of experience as a highly ...
Breaking Medicine Technology:
(Date:8/23/2017)... ... August 23, 2017 , ... Arizona ... hospitals nationally that earned the designation of High Performing Hospitals by U.S. News ... performing indicates a hospital was significantly better than the national average in a ...
(Date:8/23/2017)... ... August 23, 2017 , ... ... Golden Bridge Awards® - for Risk Management Solution Innovations and Security Solution for ... online platform released in 2017 and its DHS SAFETY Act-designated enterprise security assessment ...
(Date:8/22/2017)... ... August 22, 2017 , ... The ... health is as simple as eating healthy foods. But this well-known piece of ... making insulin, or breaking apart carbohydrates—depends not only on properties of the food ...
(Date:8/22/2017)... ... August 22, 2017 , ... Nurses at Apple Rehab Watch ... Cove, recently received training and certification in Closed Pulse Irrigation™ (CPI) for ... five-star rating from the Centers for Medicare and Medicaid Services, to have a CPI ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Covert ... the creation of published author, Julianne Hale, a consultant for the Intelligence Community. ... counter-terrorism expert focusing on the Near East region. Julianne has written hundreds ...
Breaking Medicine News(10 mins):