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QIAGEN Adds Promising New Biomarker to Pipeline of Personalized Healthcare Assays to Improve Diagnosis of Blood Disorders

April 10, 2014

HILDEN, Germany and VIENNA, April 10, 2014 /PRNewswire/ –

        - Reliable diagnostic tools under development for mutations of calreticulin
          (CALR) are expected to benefit patients with blood disorders known as
          myeloproliferative neoplasms
        - QIAGEN acquired exclusive worldwide license for CALR biomarker from CeMM
          Vienna, whose researchers recently published the discovery in the New England Journal
          of Medicine
        - Addition of CALR biomarker expands market-leading position in Personalized
          Healthcare in blood disorders, which includes JAK2, BCR-ABL and other assays

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has
acquired an exclusive worldwide license to the biomarker calreticulin (CALR), whose
recently discovered mutations are found in an estimated 15% of cases of myeloproliferative
neoplasms (MPNs), a group of blood disorders. QIAGEN licensed the technology from CeMM
Vienna, the Research Center for Molecular Medicine of the Austrian Academy of Sciences,
whose scientists led a team that discovered the presence of mutations of the CALR protein
in MPNs. QIAGEN plans to develop a molecular diagnostic test for the CALR mutations to
offer each patient a clearer prognostic profile and to guide disease management.
Development of a CALR diagnostic test is expected to be highly complementary to QIAGEN’s
kits for a key mutation of the Janus kinase 2 (JAK2) gene.

Myeloproliferative neoplasms, a group of blood disorders involving overproduction of
blood cells, are chronic diseases that can lead to several complications including
thrombosis (blood clots) and in some cases difficult-to-treat acute leukemia. QIAGEN
already has an exclusive license for the JAK2 V617F mutation, which is present in about
75% of patients with MPNs. According to an article published in the New England Journal of
Medicine in December 2013 by the CeMM team led by Robert Kralovics, patients with CALR
mutations suffer from a milder form of the disease than those with the JAK2V617F mutation,
including a lower risk of thrombosis and a higher survival rate.

“This novel biomarker offers an exciting opportunity to broaden QIAGEN’s
market-leading position in developing molecular diagnostics for the whole range of blood
disorders. Together, the JAK2 and CALR biomarkers give us the ability to deliver
personalized insights regarding diagnosis, prognosis and disease management for patients
with myeloprofilerative disorders,” said Peer M. Schatz, Chief Executive Officer of
QIAGEN. “We are now looking forward to developing clinically proven tests for detection of
CALR mutations on Rotor-Gene Q MDx, which is part of our industry-leading QIAsymphony
family of automated platforms. CALR and JAK2 could also be promising targets for companion
diagnostics as future drug candidates for these blood disorders may be linked to these
biomarkers.”

Giulio Superti-Furga, Scientific Director of CeMM, said: “We estimate that up to 3
million people worldwide suffer from myeloproliferative neoplasms, and discovery of the
CALR mutation by our CeMM and Medical University of Vienna research teams is a very
important finding for the benefit of these patients. We are pleased to license the CALR
biomarker to QIAGEN. The development of a standardized test will enable physicians to
provide improved patient care. At the same time, our researchers will continue to advance
the understanding of these diseases and to focus on developing novel treatment options.
CeMM is constantly investing in basic research aimed at obtaining new insights in
potential diagnostics and therapeutics.”

With the technologies licensed from CeMM, QIAGEN plans to develop commercial kits for
the detection of CALR mutations and seek regulatory approvals for those products. These
diagnostics will join the growing portfolio of kits designed to run on the QIAsymphony
automation platform. In addition, the license from CeMM includes potential use of the
biomarker in next-generation sequencing applications.

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 December 31, 2013,
QIAGEN employed approximately 4,000 people in more than 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-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
, personalized healthcare, clinical research, proteomics
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
, women’s health/HPV
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
testing and nucleic acid
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
-based molecular diagnostics
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&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).

        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

        pr.qiagen.com [http://www.qiagen.com/About-Us/Press-and-Media ]

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

        Email: ir@qiagen.com
        ir.qiagen.com [http://www.qiagen.com/About-Us/Investors ]

SOURCE Qiagen


Source: PR Newswire



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