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

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

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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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,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
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
Preparing for Potential Zika Outbreaks
Experts at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) are developing tools to monitor the spread of the Zika virus and are conducting research to gather more solid data to better assess the risks associated with the infection.
What do Banana Peels and Human Skin Have in Common?
Human skin and banana peels have something in common: they produce the same enzyme when attacked. By studying fruit, researchers have come up with an accurate method for diagnosing the stages of this form of skin cancer.
Biomarker for Recurring HPV-Linked Oropharyngeal Cancers
A look-back analysis of HPV infection antibodies in patients treated for oropharyngeal (mouth and throat) cancers linked to HPV infection suggests at least one of the antibodies could be useful in identifying those at risk for a recurrence of the cancer, say scientists at the Johns Hopkins University.
Counting Cancer-busting Oxygen Molecules
Researchers from the Centre for Nanoscale BioPhotonics (CNBP), an Australian Research Centre of Excellence, have shown that nanoparticles used in combination with X-rays, are a viable method for killing cancer cells deep within the living body.
Genomic Signature Shared by Five Types of Cancer
National Institutes of Health researchers have identified a striking signature in tumor DNA that occurs in five different types of cancer.
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
"Gene Fusion" Drives Childhood Brain Cancers
Study co-led by Penn scientists highlights potential targets for future cancer therapies.
Head Injury Patients Develop Brain Clumps Associated with Alzheimer’s Disease
Scientists have revealed that protein clumps associated with Alzheimer's disease are also found in the brains of people who have had a head injury.
New Way to Identify Brain Tumor Aggressiveness
Looking at a brain tumor’s epigenetic signature may help guide therapy.
OncoCyte, The Wistar Institute Enter Global Licensing Agreement
Exclusive rights to commercialize biomarker assay follows years of positive collaboration on lung cancer diagnostic test.
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!