Corporate Banner
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 3,200+ scientific posters on ePosters
  • More than 4,700+ 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
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
Scientific News
Implementation Science Approaches to Reduce Mother-to-Child HIV Transmission
The NIH study will investigate best practices to ease major disease burden in Sub-Saharan Africa.
Portable Test Rapidly Detects Zika
To better diagnose and track the disease, scientists are now reporting a new $2 test that in the lab can accurately detect low levels of the virus in saliva.
New Nanoparticle Technology Developed to Treat Aggressive Thyroid Cancer
Researchers from Brigham and Women’s Hospital have developed a nanoplatform that can deliver RNAi agents to sites of anaplastic thyroid cancer.
Some Women With PCOS May Have Adrenal Disorder
Researchers at NIH have found that a subgroup of women with PCOS, a leading cause of infertility, may produce excess adrenal hormones.
Faster Detection of Pathogens in the Lungs
Thanks to new molecular-based methods, mycobacterial pathogens that cause pulmonary infections or tuberculosis can now be detected much more quickly.
Proteins in Blood of Heart Disease Patients May Predict Adverse Events
Nine-protein test shown superior to conventional assessments of risk.
£14m EU Project To Aid Meningitis Diagnosis and Cut Antibiotic Use
An international team of doctors are aiming to develop a rapid test to allow medics to quickly identify bacterial infection in children.
Bringing AFM to Medical Diagnostics
Company has announced that its NanoWizard® AFM and ForceRobot® systems are being used in the field of medical diagnostics in the Supersensitive Molecular Layer Laboratory of POSTECH in Korea.
Scientific Gains May Make Electronic Nose the Next Everyday Device
UT Dallas team breathes new life into possibilities by using CMOS integrated circuits technology.
Electronic Sensor Tells Dead Bacteria From Live
The sensor, which measures 'osmoregulation', is a potential future tool for medicine and food safety.
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!