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QIAGEN's KRAS Companion Diagnostic for Colorectal Cancer Adopted by Clarient, a Leading U.S. Oncology Service Lab

QIAGEN's KRAS Companion Diagnostic for Colorectal Cancer Adopted by Clarient,
                     a Leading U.S. Oncology Service Lab

PR Newswire

HILDEN, Germany and GERMANTOWN, Maryland, January 30, 2013

HILDEN, Germany and GERMANTOWN, Maryland, January 30, 2013 /PRNewswire/ --

  oMomentum builds fortherascreen^® KRAS RGQ PCR Kitand Rotor-Gene Q MDx
    instrument

  oClarient offers network of 2,000-plus pathologists testing
    withtherascreenKRAS RGQ PCR Kit, the only FDA-approved KRAS companion
    diagnostic for Erbitux^® in metastatic colorectal cancer

  oKRAS launch prepares way for QIAGEN's growing pipeline of Personalized
    Healthcare content

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that
Clarient - a GE Healthcare Company and leading provider of cancer laboratory
testing services in the United States - has adopted the use of the
therascreen^® KRAS RGQ PCR Kit (therascreen KRAS test) as a companion
diagnostic to guide the use of Erbitux^® (cetuximab) as a treatment in
patients with metastatic colorectal cancer. Clarient, with a customer base of
more than 2,000 pathologists, oncologists, clinical laboratories and
hospitals, selected QIAGEN's therascreen KRAS test and QIAGEN's Rotor-Gene Q
MDx instrument following the Food and Drug Administration (FDA) approval of
the test in July 2012. Clarient joins a rapidly growing number of laboratories
switching from laboratory-developed tests (LDTs) to the FDA-approved
therascreen KRAS test for diagnostic testing for late stage colorectal cancer.

"We are very pleased to partner with Clarient, a leading laboratory with a
strong reputation among pathologists, oncologists and hospitals, to offer the
therascreen KRAS test. Together, we will help bring our shared vision of the
value of personalized healthcare to reality and transform outcomes by
delivering personalized information to guide physicians and patients in the
treatment of late-stage colorectal cancer," said Dr. Helge Lubenow, Senior
Vice President, Molecular Diagnostics Business Area and member of the
Executive Committee of QIAGEN. "The future of Personalized Healthcare will be
shaped by standardized tests like the therascreen KRAS test, backed by
scientific rigor and regulatory review. Our growing portfolio of innovative
diagnostics and efficient automation platforms is making healthcare more
effective, saving money for payers and improving life for patients."

"We believe precision medicine is the new direction in diagnosing and treating
cancer and Clarient uses state-of-the-art diagnostic technologies like the
therascreen KRAS test to bring clarity and precision to physicians to assist
them in making better treatment decisions for their patients," said Carrie
Eglinton Manner, CEO, Clarient. "Clarient's comprehensive offering and fast
turnaround time coupled with our experience with the therascreen KRAS test
permits us to provide a higher level of performance. Also, the fact that it is
FDA approved provides Clarient with additional assurance of its quality and
reliability."

The U.S. launch of the therascreen KRAS test system including the Rotor-Gene Q
MDx instrument, approved by the FDA in July 2012, is progressing well. To
drive adoption, QIAGEN supports partners like Clarient with co-marketing
programs, reimbursement service, on-site validation and communication with
pathologists and oncologists. For an updated list of U.S. laboratories now
offering the therascreen KRAS test, please visit
http://www.qiagen.com/mc/therascreenkrastest/patient/labfinder.aspx.

Approximately 110,000 metastatic colorectal cancer patients each year in the
U.S. could benefit from KRAS testing, according to QIAGEN estimates. In
patients for whom standalone surgery and chemotherapy are insufficient,
treatment with an epidermal growth factor receptor (EGFR) inhibitor such as
Erbitux has been shown to improve overall survival. However, determining the
presence or absence of KRAS mutations in tumors affects outcomes.
Approximately 60% of patients, whose tumors have mutation-negative (wild-type)
KRAS genes, may benefit from anti-EGFR therapy. Approximately 40%, whose
tumors have KRAS mutations, may not benefit.

QIAGEN's FDA-approved therascreen KRAS test offers a fast, consistent and
reliable process to determine optimal treatment for colorectal cancer patients
who are candidates for EGFR-inhibitor therapy. QIAGEN's therascreen KRAS test
has been shown to have a high sensitivity (low limit of detection) for KRAS
mutations, a critical factor in ensuring high-quality data for treatment
decisions.

The U.S. healthcare system could save more than $600 million a year by
determining KRAS status in colorectal cancer patients and avoiding unnecessary
use of medicines, studies show.

QIAGEN is actively expanding its global portfolio of Personalized Healthcare
technologies and intends to submit several companion diagnostics for U.S.
regulatory approval. Earlier this month the Company announced submission of
its therascreen^® EGFR RGQ PCR Kit to the FDA as a proposed companion
diagnostic to guide treatment with afatinib, a new investigational oncology
compound developed by Boehringer Ingelheim. More than 15 projects are under
way to co-develop and market companion diagnostics with other leading
pharmaceutical and biotech companies such as Amgen, AstraZeneca, Bayer and
Pfizer.

The U.S. rollout of the therascreen KRAS test builds on success in Europe,
where QIAGEN offers 10 CE-marked assays based on real-time PCR technology or
on Pyrosequencing. QIAGEN currently markets therascreen assays in Europe for
biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT and UGT1A1. In
Japan, regulators approved the therascreen KRAS and EGFR kits in 2011,
solidifying QIAGEN's leadership in that market. QIAGEN also offers
technologies for research use in the development of new medicines and
companion diagnostics.

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, 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,
personalized healthcare, clinical research, proteomics, women's health/HPV
testing and nucleic acid-based molecular 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:

QIAGEN

Investor Relations

John Gilardi
Albert F. FleuryPeter Vozzo
e-mail: ir@qiagen.com
+49-2103-29-11711
+1-240-751-7400

Public Relations

Dr. Thomas Theuringer
e-mail: pr@qiagen.com
+49-2103-29-11826

SOURCE Qiagen N.V.
 
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