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

QIAGEN Submits Companion Diagnostic to FDA

Published: Tuesday, January 22, 2013
Last Updated: Tuesday, January 22, 2013
Bookmark and Share
Companion diagnostic intended to aid treatment decisions in non-small cell lung cancer.

QIAGEN N.V. announced submission of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration (FDA) as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. Afatinib has been accepted for filing and granted Priority Review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation detected by an FDA-approved test.

QIAGEN submitted a Premarket Approval (PMA) application for use of the therascreen EGFR test to determine which NSCLC patients would be potentially eligible for treatment with afatinib. The companion diagnostic was developed in collaboration with Boehringer Ingelheim. In September 2012, the proposed drug also has been submitted to the European Medicines Agency (EMA). A version of the therascreen EGFR test has already been CE-marked and is available for diagnostic use in Europe. In late 2011, the test has also received regulatory approval in Japan, the world’s second largest market for Personalized Healthcare.

Lung cancer is the deadliest form of cancer. More than 200,000 new lung cancer cases in the United States and 391,000 in Europe are diagnosed each year, leading to an estimated 160,000 deaths in the U.S. and 340,000 in Europe. NSCLC accounts for about 85% of all lung cancer cases. Tumors in 10% to 15% of Caucasians and about 40% of Asians with NCSLC have mutations involving EGFR, a protein found on the surface of cells. EGFR mutations can lead to its constant activation (or over-expression), which is associated with uncontrolled cell division and development of advanced NSCLC. The submission of the afatinib registration is supported by the findings of Boehringer Ingelheim's LUX-Lung 3 study, the largest Phase III trial conducted to date in untreated patients with locally advanced or metastatic NSCLC with a confirmed EGFR mutation-positive status, using the therascreen EGFR test.

"When approved, the therascreen EGFR test will enable doctors to make informed treatment decisions for many cancer patients. Submission of therascreen EGFR test, which runs on Rotor-Gene Q, is another milestone for our Personalized Healthcare franchise," said Peer M. Schatz, Chief Executive Officer of QIAGEN. “We continue to advance our strategic initiative to add new test content by seeking regulatory approval for diagnostic kits to run on modules of the QIAsymphony family. The therascreen EGFR test will add to QIAGEN’s menu of other therascreen assays including the therascreen® KRAS RGQ PCR Kit launched last year in the U.S. The breadth and quality of this menu will create significant value for laboratories, oncologists, patients and payers seeking the best outcomes by leveraging the potential of Personalized Healthcare.”

Dr. Helge Lubenow, Senior Vice President, Molecular Diagnostics Business Area and member of the Executive Committee of QIAGEN, added: "The success of our collaboration with Boehringer Ingelheim in developing the therascreen EGFR test with afatinib exemplifies our strategy of partnering with leading pharmaceutical and biotech companies to commercialize companion diagnostics. We are uniquely committed to supporting the emergence of Personalized Healthcare, and QIAGEN’s pipeline of innovative technologies and biomarkers is positioned to fuel growth in this field for years to come.”

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 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, Astellas CDx Partnership
Collaboration provides options for collaboration across therapeutic areas, sample types and testing technologies.
Thursday, October 30, 2014
QIAGEN, BGI Tech Database Agreement
BGI Tech will provide services to the Greater China market with the widely used HGMD literature source.
Friday, August 01, 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
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
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.
The MaxSignal Colistin ELISA Test Kit from Bioo Scientific
Kit can help prevent the antibiotic apocalypse by keeping last resort drugs out of the food supply.
"Good" Mozzie Virus Might Hold Key to Fighting Human Disease
Australian scientists have discovered a new virus carried by one of the country’s most common pest mosquitoes.
Non-Disease Proteins Kill Brain Cells
Scientists at the forefront of cutting-edge research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s have shown that the mere presence of protein aggregates may be as important as their form and identity in inducing cell death in brain tissue.
Closing the Loop on an HIV Escape Mechanism
Research team finds that protein motions regulate virus infectivity.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
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.
Biologists Induce Flatworms to Grow Heads and Brains of Other Species
Findings shed light on role of a new kind of epigenetic signaling in evolution, could yield clues for understanding birth defects and regeneration.
Fat Cells Originating from Bone Marrow Found in Humans
Cells could contribute to diabetes, heart disease.
Scroll Up
Scroll Down
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