Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

QIAGEN Seeks U.S. Regulatory Clearance for Full QIAsymphony RGQ MDx Workflow

Published: Friday, January 31, 2014
Last Updated: Thursday, January 30, 2014
Bookmark and Share
Diagnostic workflow for C. difficile is launched in Europe and submitted in the U.S. for 510(k) clearance as the first of several new kits in QIAGEN’s pipeline for HAI.

QIAGEN N.V. has announced plans to roll out a portfolio of assays for the QIAsymphony platform to aid in the diagnosis of healthcare-associated infections.

The first new test the artus C. difficile QS-RGQ MDx Kit has been submitted to the U.S. Food and Drug Administration (FDA). QIAGEN already launched a C. difficile test in Europe after receiving CE-marking in December.

Along with the C. difficile test, QIAGEN also submitted the automation platform QIAsymphony RGQ MDx to the FDA. QIAsymphony is a modular system that covers entire laboratory workflows from sample to results. It is composed of QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012. While the QIAsymphony platform has the broadest menu in its category in Europe and other markets, the system is currently primarily used for laboratory developed assays in the United States.

“QIAGEN’s highly reliable diagnostics running on the QIAsymphony platform allow customers to experience excellent assay performance, quicker results to benefit patients, and improved laboratory efficiency. The expanding content menu adds value to QIAsymphony, which has become the system of choice in medium-throughput molecular testing,” said Peer M. Schatz, Chief Executive Officer.

“The U.S. submission of the QIAsymphony RGQ MDx system is a pivotal step in expanding global adoption of the QIAsymphony platform to revolutionize laboratory workflows. As novel new content continues to emerge from our pipeline, users will be able to consolidate the broadest range of molecular tests available on a single instrument platform,” Mr. Schatz said. “The QIAsymphony platform is positioned for long term, strong growth for QIAGEN. In 2013 we exceeded our target of 1,000 placements and we now target more than 1,250 placements by the end of 2014 and 1,500 by the end of 2015. The strong increase in placements coupled with the expanding menu creates an exciting future for this franchise.”

Healthcare-associated infections - addressing an urgent need

Healthcare-associated infections (also called HAIs) affect an estimated 5.8 million hospitalized patients a year in Europe and the United States, leading to more than 100,000 deaths, according to the World Health Organization. These pathogens also impose an economic burden with direct costs estimated at 7 billion euros in Europe and $6.5 billion in the U.S. due to extra days of hospitalization, according to the World Health Organization. Figures are less precise in less developed regions of the world, but HAIs pose a global challenge in healthcare.

The C. difficile tests launched in Europe and under review in the U.S. will aid in the diagnosis of Clostridium difficile infection, the most prevalent HAI in the United States. C. difficile often infects patients in hospitals or nursing facilities, causing symptoms ranging from diarrhea to life-threatening inflammation of the colon. QIAGEN’s ready-to-use molecular assay delivers sensitive and specific detection of both toxin A and toxin B of C. difficile. This assay for the QIAsymphony system was developed in partnership with IntelligentMDx, based in Waltham, Massachusetts, under a multiyear agreement.

QIAGEN aims to market the broadest test portfolio for healthcare associated infections in Europe, North America and rest of the world. The VanR and MRSA/SA tests are in advanced stage of development and will be submitted for clearance this year, followed by further additions to QIAGEN’s HAI panel as well as other panels.

QIAsymphony content menu expanding

QIAGEN’s portfolio now includes more than 20 CE-marked assays in Europe along with one FDA-cleared and two FDA-approved diagnostic assays in the United States designed to run on the Rotor-Gene Q MDx platform, which is part of the QIAsymphony family. About 35 new tests are currently in development for a variety of biomarkers.

In Personalized Healthcare, the QIAsymphony content menu continues to add companion diagnostics in cancer and other diseases. In January, the CE-marked therascreen IDH1/2 RGQ Kit was launched in Europe, enabling physicians to better diagnose and assess the prognosis of patients with gliomas (tumors of the brain and spinal cord). QIAGEN has partnered with more than 15 leading pharmaceutical and biotechnology companies to co-develop additional companion diagnostics.

In Profiling of infectious diseases, the RespiFinder RG Panel, a multiplex PCR assay for the simultaneous detection and differentiation of 21 respiratory pathogens, also was recently launched in Europe. It is the first highly multiplexed pathogen assay designed to run on the Rotor-Gene Q.


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 3,300+ scientific posters on ePosters
  • More than 4,800+ 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.

Related Content

Qiagen Completes Exiqon Tender Offer
Transaction will enhance leadership position in RNA solutions from Sample to Insight.
Friday, June 24, 2016
QIAGEN Partners to Develop Predictive Tests in Oncology
Collaboration with Therawis addresses unmet need to guide clinical decisions in breast cancer.
Friday, May 27, 2016
QIAGEN,Biotype Diagnostics Form Partnership
New “Biotype Innovation” to develop workflows for personalized health-care and other applications based on QIAGEN’s ModaPlex platform.
Monday, June 29, 2015
Hitachi High-Technologies, QIAGEN Collaborate
Hitachi High-Technologies Corporation and QIAGEN N.V. have entered into a long-term strategic collaboration involving initiatives to deliver important advances in molecular testing.
Thursday, June 18, 2015
QIAGEN Expands Leadership in Liquid Biopsies
QIAGEN and Tokai Pharmaceuticals to co-develop and commercialize the first regulated CTC-based companion diagnostic to guide treatments in prostate cancer.
Tuesday, March 17, 2015
QIAGEN Collaborates with Allele Frequency Community
QIAGEN providing secure bioinformatics infrastructure and software for research and clinical labs to contribute and gain insights from Allele Frequency Community.
Wednesday, February 25, 2015
QIAGEN, Astellas CDx Partnership
Collaboration provides options for collaboration across therapeutic areas, sample types and testing technologies.
Thursday, October 30, 2014
QIAGEN, AstraZeneca to Develop Liquid Biopsy-based Companion Diagnostic
The collaboration is to advance EGFR mutation profiling in lung cancer patients.
Monday, July 28, 2014
QIAGEN Licenses Blood Cancer Biomarkers
Exclusive global license from University of Tokyo enables development of QIAGEN assays for SF3B1 mutations, including NGS gene panels, for blood cancers.
Saturday, July 26, 2014
QIAGEN Receives FDA Approval for CMV Assay
Assay offers faster quantification of CMV DNA levels in patient samples.
Friday, June 20, 2014
QIAGEN, Lilly form CDx Collaboration
Companies to co-develop companion diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers.
Friday, May 30, 2014
FDA Approve QIAGEN PCR Kit For Use With Second Colorectal Cancer Drug
Clinically proven companion diagnostic gains U.S. approval to guide use of Amgen’s Vectibix® (panitumumab) in treatment of metastatic colorectal cancer.
Tuesday, May 27, 2014
QIAGEN Integrates Content from BIOBASE
The new content expands the world’s most comprehensive, high-quality and up-to-date literature source for clinical research and diagnosis.
Wednesday, May 21, 2014
QIAGEN Receives FDA Clearance for QIAsymphony RGQ MDx
Clearance marks a milestone for one of the Company’s major global growth drivers.
Monday, May 05, 2014
QIAGEN Licences Biomarker for Blood Disorder from CeMM Vienna
Company plans to develop a molecular diagnostic test for the calreticulin mutations.
Thursday, April 10, 2014
Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
CDC Updates Zika Recommendations
CDC has issued updated Zika recommendations and guidance for healthcare providers with a focus on sexual transmission.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
SELECTBIO

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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!