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

QIAGEN Receives FDA Approval for CMV Assay

Published: Friday, June 20, 2014
Last Updated: Monday, June 23, 2014
Bookmark and Share
Assay offers faster quantification of CMV DNA levels in patient samples.

QIAGEN N.V. announced that its artus® CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the U.S. Food and Drug Administration (FDA) under a full premarket approval (PMA). The test is the only FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests. artus CMV RGQ MDx runs on QIAGEN’s Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony modular family of automated instruments.

“We are very pleased to add yet another FDA approved diagnostic kit to our menu of FDA approved or cleared content for a core element of our flagship QIAsymphony modular family of automated instruments. This flexible platform is driving the dissemination of molecular diagnostics by delivering efficient, reliable workflows in low- to mid-throughput settings, which represent the largest market opportunity in terms of placements,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Our artus CMV assay is the fastest test approved for quantifying CMV viral loads in organ transplant patients. In addition to helping save lives with its clinically proven usefulness, the FDA-approved artus test creates economic value by reducing the time and money many labs and hospitals currently must spend validating lab-developed CMV tests and analyte-specific reagents. More than one million CMV tests are performed on U.S. transplant patients each year and we believe the artus CMV kit will provide significant value for laboratories, patients and the healthcare system.”

CMV testing is primarily used as an aid in the management of solid organ transplant patients to assess viral load in response to antiviral drug therapy. These patients are at high risk of life-threatening CMV infections in the months following surgery, and antiviral drug treatment is standard. Between 20% and 60% of all transplant patients, depending on patient and procedure, are repeatedly tested for CMV throughout the first year following transplantation.

Expanding the menu for QIAsymphony 
QIAGEN is delivering on a broad pipeline of tests targeting regulatory clearance and approval for use on the QIAsymphony modular family of automated instruments. Approximately 40 molecular diagnostics are already today available in various markets for use on the QIAsymphony platform and its modules, and about 35 new tests are currently in development for a variety of targets in disease areas such healthcare-associated infections, women’s health, transplantation, personalized healthcare, oncology and blood- borne viruses.

With more than 25 CE-marked assays, QIAGEN offers the industry’s broadest test menu in Europe, including more than 10 assays for personalized healthcare and more than 15 assays in women’s health, blood-borne virus and other disease areas. The CE-marking of artus® GBS QS-RGQ Kit for detection of Group B Streptococcus (GBS) represents the most recent addition to QIAGEN’s growing QIAsymphony test menu. The test was developed in partnership with Intelligent MDx. For healthcare-associated infections, QIAGEN already offers the CE-marked artus VanR QS-RGQ Kit for vancomycin-resistant bacteria, the artus C. difficile QS-RGQ Kit and the artus MRSA/SA QS-RGQ Kit for detection of methicillin-resistant Staphylococcus aureus infections (MRSA). Furthermore, a women’s health assay for the detection of Trichomonas is planned for 2014 in Europe.

In the United States, QIAGEN is building a growing menu of approved or cleared assays for the QIAsymphony automation family in a number of focus areas including companion diagnostics, healthcare-associated and transplantation-related infections. To date, the FDA has granted three PMA approvals for companion diagnostics developed by QIAGEN to guide treatment of various cancers with targeted drugs. For healthcare-associated infections, the FDA has cleared the U.S. application for artus C. difficile QS-RGQ MDx kit, and artus assays for VanR and MRSA have been or will be submitted to the agency for regulatory clearance. Further 510(k) submissions planned include women’s health assays for the detection of CT/NG and Trichomonas infections as well as for HSV 1/2, which is expected for July 2014.

The assays listed above represent important menu items for use in the low- to medium throughput testing segments (e.g. pathology, esoteric testing, hospitals, medium to low throughput laboratories), which in terms of placements are estimated to in sum represent the largest market opportunities. The QIAsymphony modular family of automated instruments has ideal features and specifications for customers in these market segments, including random access and continuous loading of samples. The full QIAsymphony RGQ MDx platform has been cleared by the FDA earlier this year. For 2014, QIAGEN is targeting 250 new system placements worldwide, building on the more than 1,000 cumulative placements at the end of 2013. 

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,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, 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
QIAGEN and Exosome Diagnostics Expand Partnership
Partnership aims to develop a first-in-class, non-invasive molecular in-vitro diagnostics for use in diagnosing and monitoring patients.
Monday, January 13, 2014
QIAGEN Reports Second Quarter 2013 Results and Announces New Share Repurchase Program
Company is building momentum in Personalized Healthcare with FDA approval of therascreen EGFR companion diagnostic and new pharma co-development projects.
Wednesday, July 31, 2013
QIAGEN Expands Pipeline of Promising New Biomarkers for Development of Companion Diagnostics
Several lymphoma-related biomarkers, including EZH2 Y641 gene mutations, rights acquired from British Columbia Cancer Agency.
Monday, June 10, 2013
Scientific News
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
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.
Biomedical Imaging at One-Thousandth the Cost
Mathematical modeling enables $100 depth sensor to approximate the measurements of a $100,000 piece of lab equipment.
Improving Outcomes for Lung Cancer and Diabetic Patients
Novel technologies have been developed with support from SBRI Healthcare funding.
New Way of Detecting Cancer
A new RNA test of blood platelets can be used to detect, classify and pinpoint the location of cancer by analysing a sample equivalent to one drop of blood.
Rapid, Portable Ebola Diagnostic
Scientists confirmed the efficiency of the novel Ebola detection method in field trials.
New, Better Test for Prostate Cancer
A study from Karolinska Institutet shows that a new test for prostate cancer is better at detecting aggressive cancer than PSA.
Blood Test Picks Out Prostate Cancer Drug Resistance
Scientists have developed a blood test that can identify key mutations driving resistance to a widely used prostate cancer drug, and identify in advance patients who will not respond to treatment.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.
Key Piece of MRSA Vaccine Puzzle
New research funded by the Health Research Board and the Wellcome Trust has pinpointed immune cells that could be targeted by an MRSA vaccine.
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