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

QIAGEN Receives FDA Clearance for QIAsymphony RGQ MDx

Published: Monday, May 05, 2014
Last Updated: Wednesday, May 07, 2014
Bookmark and Share
Clearance marks a milestone for one of the Company’s major global growth drivers.

QIAGEN N.V. today announced that its artus C. difficile QS-RGQ MDx Kit has been cleared by the U.S. Food and Drug Administration to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection (HAI). In addition, the FDA has granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx system, QIAGEN’s flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics. The U.S. milestone for QIAGEN’s global rollout of its sample-to-result automation platform, together with the FDA clearance of the first in a portfolio of tests for HAI infections, supports the expected growth in QIAsymphony placements globally to more than 1,250 by year-end 2014 and 1,500 by year-end 2015.

“Our QIAsymphony RGQ platform is revolutionizing laboratory workflows with flexible, efficient automation from sample to result – and the U.S. clearance affirms that we are well on track with our targets for this important growth driver,” said Peer M. Schatz, Chief Executive Officer. “QIAGEN is now positioned to rapidly expand the menu of standardized, regulator-approved diagnostic kits running on QIAsymphony. Our FDA cleared artus C. difficile QS-RGQ MDx Kit provides reliable detection of both the Toxin A and Toxin B of the infection. artus C. difficile QS-RGQ MDx Kit is the first test of our planned HAI portfolio in the United States. As we continue to deliver on a deep pipeline for infectious diseases and personalized healthcare diagnostics, the growing menu adds value for customers and patients by allowing consolidation of more tests on this platform.”

QIAsymphony RGQ MDx is a modular system for cost-effective handling of entire laboratory workflows. The three modules are QIAsymphony SP for sample preparation, QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012. The QIAsymphony family has the broadest test menu in its category in Europe and other markets. In the United States until now the system has been primarily used for laboratory-developed assays. The FDA clearance therefore marks an important milestone as a record number of assays is now positioned to be submitted for clearance or approval in the United States. With the launch of the artus C. difficile test, QIAGEN now offers four FDA-regulated diagnostics designed to run on the QIAsymphony family of automated platforms. In Europe, more than 20 CE-marked assays run on the system. Innovation continues to expand the content menu, with about 35 new tests in development.

The artus C. difficile kit, already available in Europe, will be the first U.S. launch among QIAGEN’s advanced diagnostics for healthcare-associated infections. Additional workflows for HAIs include the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe and expected to be submitted in the second quarter 2014 to the FDA; the artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus (MRSA), expected to be launched in Europe during the second quarter 2014 and to be submitted to the FDA in the third quarter 2014; and further additions under development. QIAGEN also is in advanced stages of developing test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV1/2).

The artus C. difficile test was developed in partnership with IntelligentMDx under a multiyear agreement.

Further Information
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 2,800+ scientific posters on ePosters
  • More than 4,000+ 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 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 Signs Ninth Master Collaboration Agreement for Companion Diagnostics
Master collaboration agreement is a framework for developing and commercializing QIAGEN companion diagnostics, paired with new or existing products.
Thursday, November 13, 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 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 Licences Biomarker for Blood Disorder from CeMM Vienna
Company plans to develop a molecular diagnostic test for the calreticulin mutations.
Thursday, April 10, 2014
QIAGEN Partners with Exosome Diagnostics
Molecular testing of biofluids promises unprecedented access to gene mutations, gene expression signatures and expression levels without costly, invasive tissue biopsies.
Wednesday, July 24, 2013
QIAGEN Acquires Ingenuity Systems
Suite of web-based applications powered by a unique expert-curated Knowledge Base eases major bottlenecks to leveraging genomic data in research and clinical diagnostics.
Thursday, May 02, 2013
QIAGEN’s KRAS Companion Diagnostic for Colorectal Cancer Adopted by Clarient
Clarient offers network of 2,000-plus pathologists testing with therascreen KRAS RGQ PCR Kit, the companion diagnostic for Erbitux® in metastatic colorectal cancer.
Wednesday, January 30, 2013
QIAGEN Submits Companion Diagnostic to FDA
Companion diagnostic intended to aid treatment decisions in non-small cell lung cancer.
Tuesday, January 22, 2013
QIAGEN Adds to Pipeline of Personalized Healthcare Diagnostics
Includes investment in new companion diagnostic that aims to predict efficacy of TNF-alpha inhibitors in rheumatoid arthritis patients.
Tuesday, January 08, 2013
QIAGEN Achieves Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer
U.S. launch of therascreen® KRAS RGQ PCR kit offers enhanced approach to guide treatments for approximately 110,000 patients annually in U.S. with colorectal cancer.
Wednesday, July 11, 2012
QIAGEN Unveils Initiative to Create Next-generation Sequencing Portfolio
Company plans to offer sample-to-result workflows that integrate its sample preparation and assay products with a next-generation benchtop sequencer and new bioinformatics.
Tuesday, June 26, 2012
QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay
Both products receive 510(k) clearance for in vitro diagnostic use in the U.S..
Tuesday, April 17, 2012
Qiagen Subsidiary SABiosciences Expands RT2 Profiler PCR Arrays
Now more than 100 arrays for various disease areas available
Monday, July 05, 2010
Scientific News
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Best Test to Diagnose Strangles in Horses Identified
New research by Dr. Ashley Boyle of New Bolton Center’s Equine Field Service team shows that the best method for diagnosing Strangles in horses is to take samples from a horse’s guttural pouch and analyze them using a loop-mediated amplification (LAMP) polymerase chain reaction (PCR) test.
Tardigrade's Are DNA Master Thieves
Tardigrades, nearly microscopic animals that can survive the harshest of environments, including outer space, hold the record for the animal that has the most foreign DNA.
Rapid, Portable Ebola Diagnostic
Scientists confirmed the efficiency of the novel Ebola detection method in field trials.
Detecting When Hormone Treatment for Breast Cancer Stops Working
Scientists have developed a highly sensitive blood test that can spot when breast cancers become resistant to standard hormone treatment, and have demonstrated that this test could guide further treatment.
Packaging and Unpacking of the Genome
New research improves understanding of the importance of histone replacement.
New Way to Find DNA Damage
University of Utah chemists devised a new way to detect chemical damage to DNA that sometimes leads to genetic mutations responsible for many diseases, including various cancers and neurological disorders.
How Different Treatments for Crohn's Effect the Microbiome
Different treatments for Crohn's disease in children affects their gut microbes in distinct ways, which has implications for future development of microbial-targeted therapies for these patients, according to a study led by researchers from the Perelman School of Medicine at the University of Pennsylvania.
Charting the 'Genomic Biography' of Leukemia
A new study by scientists at Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard offers a glimpse of the wealth of information that can be gleaned by combing the genome of a large collection of leukemia tissue samples.
Skyscraper Banner

Skyscraper Banner
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos