Last updated on April 18, 2014 at 17:24 EDT

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

January 15, 2013

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

        - U.S. submission of therascreen(R) EGFR RGQ PCR Kit is paired with FDA
          submission of afatinib, an investigational tyrosine kinase inhibitor developed by
          Boehringer Ingelheim
        - Companion diagnostic intended to aid treatment decisions in non-small cell
          lung cancer
        - QIAGEN 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(R) 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

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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

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 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(R) 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.


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
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
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
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
(human healthcare), Applied Testing
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
(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 in
applied testing
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
, personalized healthcare, clinical research, proteomics
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
, women’s health/HPV
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testing and nucleic acid
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-based molecular diagnostics
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=388&lang=EN ]
; 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).


        Public Relations:
        Dr. Thomas Theuringer
        Director Public Relations
        Email: pr@qiagen.com



        Investor Relations:
        John Gilardi
        VP Corporate Communications

        Peter Vozzo
        Director, Global Investor Relations

        Email: ir@qiagen.com




SOURCE Qiagen N.V.

Source: PR Newswire