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

FDA Approve QIAGEN PCR Kit For Use With Second Colorectal Cancer Drug

Published: Tuesday, May 27, 2014
Last Updated: Tuesday, May 27, 2014
Bookmark and Share
Clinically proven companion diagnostic gains U.S. approval to guide use of Amgen’s Vectibix® (panitumumab) in treatment of metastatic colorectal cancer.

QIAGEN announced that its therascreen® KRAS RGQ PCR Kit has received U.S. Food and Drug Administration (FDA) approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix® (panitumumab). This marks the third FDA approval of a companion diagnostic from QIAGEN that has been paired with a novel medicine.

QIAGEN’s growing menu of clinically validated companion diagnostics is driving global dissemination of personalized healthcare, which uses genomic information to guide treatment decisions in individual patients. 

“The U.S. approval of our therascreen KRAS test with Amgen’s EGFR inhibitor, Vectibix, marks a further milestone for QIAGEN’s global growth in companion diagnostics for personalized healthcare. Our global portfolio covers more than 25 molecular tests targeting various companion diagnostic biomarkers. The performance and ease of use of QIAGEN’s tests are now increasingly driving dissemination of personalized healthcare in the U.S. and countries around the world,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Our success in this long-standing collaboration with Amgen is a further demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for co-development and commercialization of companion diagnostics. The continuing rollout of standardized, regulatory-approved tests also is adding valuable content for our Rotor-Gene Q MDx, a real-time PCR platform in our revolutionary QIAsymphony family.”

Personalized Healthcare is a strategic growth driver for QIAGEN. In addition to the latest U.S. approval of therascreen KRAS paired with Vectibix and the 2012 approval with Erbitux, QIAGEN’s therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) was approved by the FDA in 2013 to guide the use of GILOTRIF™ (afatinib) for treatment of metastatic non-small cell lung cancer (NSCLC). In 2014, QIAGEN has launched its therascreen® IDH1/2 RGQ Kit in Europe to guide the management of patients with gliomas (tumors of the brain) and received approval in China for the therascreen EGFR test in NSCLC, the company’s first companion diagnostic in China. QIAGEN already markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, UGT1A1 and many others. In Japan, the second largest market for Personalized Healthcare, therascreen KRAS and EGFR kits were launched in 2011. 

KRAS mutations, occurring in approximately 40% of colorectal cancer patients, influence response to anti-EGFR therapies such as Vectibix and Erbitux. Screening colorectal cancer patients with therascreen KRAS detects the most frequent mutations in the KRAS gene and helps to guide treatment planning. 

QIAGEN is expanding its pipeline of biomarkers and technologies to address the continuously evolving needs of personalized healthcare, including the RAS gene family. QIAGEN is co-developing the industry’s widest range of companion diagnostics under more than 20 project agreements with pharmaceutical and biotech companies, including five master collaboration agreements.  

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 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 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
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 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
Leading Tuberculosis Experts Explore Shortcomings in Current Immigrant TB Screening Policy
Improved immigration policy and replacement of century-old diagnostic tests have potential to significantly reduce cases of latent tuberculosis in the UK.
Tuesday, December 04, 2012
QIAGEN and Cardinal Health Collaborate to Offer Molecular Diagnostic Products to Smaller and Mid-Sized U.S. Hospitals
Collaboration creates distribution channel to previously underserved market segment.
Tuesday, May 01, 2012
QIAGEN to Supply Molecular Screening Solutions to Increase Safety of Blood Donations in Brazil
The supply agreement covers molecular sample and assay technologies for a national PCR-based blood screening program for HIV and HCV.
Friday, June 05, 2009
QIAGEN to Supply Molecular Screening Solutions to Increase Safety of Blood Donations in Brazil
The agreement to supply molecular sample and assay technologies for a PCR-based blood screening program for HIV HCV in Brazil.
Friday, May 29, 2009
QIAGEN Tests Clinically Verified for the Monitoring of Swine Flu
German Bernhard Nocht Institute and Spanish Reference Laboratory detect infections with the H1N1 strain using QIAGEN’s artus influenza test.
Monday, May 04, 2009
QIAGEN and CNCI to Establish Cervical Cancer Screening Program in Kolkata
The initiative will be conducted over 5 years and is expected to reach 50,000 women.
Monday, April 27, 2009
EU Launches Project to Improve In-Vitro Diagnostics
QIAGEN led-consortium to develop standards for patient sample processing in order to facilitate the discovery and prediction of diseases.
Tuesday, January 13, 2009
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
World’s First Therapeutic Venom Database
Open-source library describes nearly 43,000 effects on the human body.
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.
Potential Persistent Tuberculosis Treatment
Researchers have discovered several first-in-class compounds that target hidden TB infections by attacking a critical process the bacteria use to survive in the hostile environment of the lungs.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
The Do’s and Don’ts of SPR Experiments
Surface Plasmon Resonance (SPR) is a technique that is becoming more widely used, particularly by anyone who wants to obtain accurate on (association) and off (dissociation) rates for biomolecular binding.
Long-Sought Protein Sensor for the ‘Sixth Sense’ Discovered
In a study led by scientists from The Scripps Research Institute (TSRI)the sensor protein for propioception has been identified.
New Anti-Malarial Drug Screening Model
University of South Florida researchers demonstrate novel chemogenomic profiling to identify drug targets for the most lethal strain of malaria.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.

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