Corporate Banner
Satellite Banner
qPCR
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

AdvanDx Announces FDA Submission for MRSA Assay

Published: Sunday, March 23, 2014
Last Updated: Thursday, March 27, 2014
Bookmark and Share
mecA XpressFISH™ will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections.

AdvanDx announced that it has submitted to the U.S. Food and Drug Administration for 510(k) clearance its new mecA XpressFISH™ test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. 

Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to antibiotics commonly used to treat ordinary staphylococcal infections. An estimated 80,461 invasive MRSA infections occurred in the U.S. in 2011. Of these, 48,353 were healthcare associated community onset infections; 14,156 were hospital-onset infections; and 16,560 were community-associated infections.(1)

Methicillin-resistance is almost exclusively caused by the presence and expression of the mecA gene that encodes a unique penicillin-binding protein (PBP2a) that has low affinity for methicillin and other b-lactam drugs.mecA XpressFISH is a qualitative fluorescence in situ hybridization (FISH) assay that utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) sequences on smears from blood cultures containingStaphylococcus aureus (SA). This “phenotypic” mRNA-targeting approach makes XpressFISH unique in its mechanism of MRSA identification.

“This is a significant breakthrough in how we identify MRSA,” says James M. Coull, Ph.D, Chief Technology Officer for AdvanDx. “By targeting mecA mRNA, mecA XpressFISH rapidly detects the presence of the mecAgene, and determines whether the gene is transcriptionally functional and therefore able to confer resistance to broad classes of antibiotics, such as penicillins and cephalosporins. This information should help clinicians quickly determine the best course of antibiotic treatment.”

Although identification of MRSA is used to guide effective therapy, conventional laboratory methods can take 48 hours to determine whether S. aureus bacteria are resistant. mecA XpressFISH will enable laboratories to rapidly detect MRSA directly from S. aureus positive blood cultures in about an hour. The rapid determination of MRSA by mecA XpressFISH should enable clinicians to prescribe more effective appropriate therapy sooner for MRSA-infected patients.

A Proven Track Record with Staphylococcal Bloodstream Infections

mecA XpressFISH is the latest addition to AdvanDx’s easy-to-use, molecular-based diagnostics platform that provides rapid identification of bloodstream pathogens in minutes instead of days. AdvanDx also markets theQuickFISH platform for rapid identification of Gram-positive and Gram-negative bacteria as well as PNA FISH forCandida species.

Since 2003, the use of AdvanDx’s flagship product, PNA FISH for rapid identification of staphylococcal bloodstream pathogens has dramatically improved therapy decisions and outcomes for patients with bloodstream infections by helping 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. (2,3)

References

1. JAMA National Burden of Invasive Methicillin-Resistant Staphylococcus aureus Infections, United States, 2011
2. Ly et al. Ther Clin Risk Manag. 2008 Jun;4(3):637-40.
3. J Antimicrob Chemother. 2006 Jul;58(1):154-8.



Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Analysing 10,000 Cells Simultaneously
New techniquethat traps 10,000 cells on a single chip has potential for cancer screening for individuals.
$1M NIH Grant to Refine PCR Based Cancer Test
Researchers at Cornell University, Weill Cornell Medicine, the University of California, San Francisco, and the Infectious Diseases Institute in Kampala, Uganda, recieve a four-year, $1 million grant to hone technology for a quick, in-the-field diagnosis of Kaposi's sarcoma — a cancer frequently related to HIV infections.
Genetic Tug of War Before Cells Decide Fate
Researchers report that as developing blood cells are triggered by genetic signals firing on and off, a 'tug of war' occurs.
Linkage Biosciences Awarded NHS Contract
Comapny announces that it has been awarded a four-year contract by NHS Blood and Transplant (NHSBT) in the UK for implementation of the LinkSeq™ Real-Time PCR HLA typing product.
Understanding Tumor Evolution
Study provides insight into tumor evolution; may point to improved diagnosis and treatment.
Frankfurter Fraud: Finding Out What’s In Your Hot Dog
Scientists have developed a technique to test the meat content of Frankfurters.
How Cloud Connectivity Can Combat the Reproducibility Crisis
This infographic explains the reproducibility crisis, and how cloud connectivity can help overcome this problem.
Keeping Cells in Shape to Fight Sepsis
Boosting levels of a protein that controls the shape and activity of a crucial group of white blood cells improves survival and recovery chances during sepsis.
This 3D Printer Can Detect Infectious Diseases
Researchers at AI Biosciences, Inc. have repurposed 3D printers into machines capable of performing sample preparation and DNA amplification.
Natera, UCSF Announce Collaboration
Joint research program to study DNA markers of kidney transplant rejection.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!