QIAGEN Submits Companion Diagnostic to FDA to Guide Treatment Decisions for New Investigational Lung Cancer Compound

 QIAGEN Submits Companion Diagnostic to FDA to Guide Treatment Decisions for
                   New Investigational Lung Cancer Compound

PR Newswire

HILDEN, Germany and GERMANTOWN, Maryland, January 15, 2013

HILDEN, Germany and GERMANTOWN, Maryland, January 15, 2013 /PRNewswire/ --

  oU.S. submission oftherascreen^®EGFR RGQ PCR Kit is paired with FDA
    submission ofafatinib, an investigational tyrosine kinase inhibitor
    developed by Boehringer Ingelheim
  oCompanion diagnostic intended to aid treatment decisions in non-small cell
    lung cancer
  oQIAGEN continues to expand Personalized Healthcare portfolio and content
    menu for modules of the QIAsymphony automation platform

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today 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) who havewith
an epidermal growth factor receptor (EGFR) mutation detected by an
FDA-approved test.

 (Photo: http://photos.prnewswire.com/prnh/20130115/588585 )

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. Clinical studies on treatment with
afatinib for EGFR mutation-positive patients, as identified by the therascreen
EGFR test, have shown improvement in progression free survival and tumor
shrinkage compared with standard chemotherapy. The submission ofthe 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 in this field for years to come."

QIAGEN markets in Europe additional therascreen assays for biomarkers
including NRAS, BRAF, PI3K, JAK2, MGMT and UGT1A1. A range of biomarker assays
and related Sample & Assay Technologies also are marketed to customers
globally for use during the research and development of new medicines.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of
Sample & Assay Technologies that are used to transform biological materials
into valuable molecular information. Sample technologies are used to isolate
and process DNA, RNA and proteins from biological samples such as blood or
tissue. Assay technologies are then used to make these isolated biomolecules
visible and ready for interpretation. QIAGEN markets more than 500 products
around the world, selling both consumable kits and automation systems to
customers through four customer classes: Molecular Diagnostics (human
healthcare), Applied Testing (forensics, veterinary testing and food safety),
Pharma (pharmaceutical and biotechnology companies) and Academia (life
sciences research). As of September 30, 2012, QIAGEN employed approximately
4,000 people in over 35 locations worldwide. Further information can be found
at http://www.qiagen.com.

Certain of the statements contained in this news release may be considered
forward-looking statements within the meaning of Section 27A of the U.S.
Securities Act of 1933, as amended, and Section 21E of the U.S. Securities
Exchange Act of 1934, as amended. To the extent that any of the statements
contained herein relating to QIAGEN's products, markets, strategy or operating
results, including without limitation its expected operating results, are
forward-looking, such statements are based on current expectations and
assumptions that involve a number of uncertainties and risks. Such
uncertainties and risks include, but are not limited to, risks associated with
management of growth and international operations (including the effects of
currency fluctuations, regulatory processes and dependence on logistics),
variability of operating results and allocations between customer classes, the
commercial development of markets for our products inapplied testing,
personalized healthcare, clinical research,proteomics, women's
health/HPVtesting andnucleic acid-basedmolecular diagnostics; changing
relationships with customers, suppliers and strategic partners; competition;
rapid or unexpected changes in technologies; fluctuations in demand for
QIAGEN's products (including fluctuations due to general economic conditions,
the level and timing of customers' funding, budgets and other factors); our
ability to obtain regulatory approval of our products; difficulties in
successfully adapting QIAGEN's products to integrated solutions and producing
such products; the ability of QIAGEN to identify and develop new products and
to differentiate and protect our products from competitors' products; market
acceptance of QIAGEN's new products, the consummation of acquisitions, and the
integration of acquired technologies and businesses. For further information,
please refer to the discussions in reports that QIAGEN has filed with, or
furnished to, the U.S. Securities and Exchange Commission (SEC).

Contacts:

Public Relations:
Dr. Thomas Theuringer
Director Public Relations
+49-2103-29-11826
+1-240-686-7425
Email: pr@qiagen.com

http://www.twitter.com/qiagen
http://www.qiagen.com/about/press

Investor Relations:
John Gilardi
VP Corporate Communications
+49-2103-29-11711
+1-240-686-2222

Peter Vozzo
Director, Global Investor Relations
+1-240-751-7400

Email: ir@qiagen.com
http://www.qiagen.com/about/investorrelation

SOURCE Qiagen N.V.
 
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