Last updated on April 16, 2014 at 10:52 EDT

QIAGEN Achieves Personalized Healthcare Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer

July 6, 2012

HILDEN, Germany, and GERMANTOWN, Maryland, July 6, 2012 /PRNewswire/ –

        - U.S. launch of therascreen(R)KRAS RGQ PCR Kit offers enhanced approach to
          guide treatments for approximately 110,000 patients annually in U.S. with colorectal
        - First FDA approval of a QIAGEN companion diagnostic marks a milestone in its
          global expansion of rapidly growing Personalized Healthcare business
        - Important cancer assay adds valuable content for an expanding QIAGEN
          automation platform

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has
received U.S. Food and Drug Administration (FDA) approval to market the therascreen(R)
[http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=355&lang=EN ]
Kit (therascreen KRAS test) to provide guidance on the use of Erbitux(R) (cetuximab) as
a treatment in patients with metastatic colorectal cancer.

The U.S. FDA approval of the KRAS test kit marks a milestone in QIAGEN’s global
expansion of its Personalized Healthcare franchise which includes an industry-leading
portfolio of molecular companion diagnostics to aid treatment decisions in oncology.
QIAGEN already markets a broad range of companion diagnostic tests covering 30 biomarkers
in Europe, Asia/Pacific and Japan.

“We are very pleased to receive FDA approval to launch our therascreen KRAS test in
the United States and to play a role in transforming the care of colorectal cancer
patients. This approval marks an important step for QIAGEN, but also an important step in
Personalized Healthcare, as we are now launching a major molecular companion diagnostic
product in the U.S.,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “With a
growing portfolio of innovative tests and efficient automation platforms, we are proud to
be helping to make healthcare more effective, providing ways for payers to more
efficiently use healthcare resources and, most important, making a positive impact on the
care of patients.”

Pioneering role in Personalized Healthcare

QIAGEN is at the forefront of developing and validating a range of tests that provide
physicians with an individual patient’s molecular information to select the most
appropriate medicines.

The entry into the U.S. market with the approval of the first therascreen test builds
on our success in the European market, where QIAGEN offers 10 CE-marked assays, based
either 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, the therascreen KRAS and EGFR kits were approved in 2011,
solidifying QIAGEN’s leadership position for companion diagnostics in the second biggest
market for Personalized Healthcare. A range of assays and related Sample & Assay
Technologies are also marketed to customers use during the research and development of new

QIAGEN is actively expanding its pipeline of Personalized Healthcare technologies and
intends to submit several companion diagnostics in the coming years for U.S. regulatory
approval. QIAGEN has more than 15 projects under way to co-develop and market companion
diagnostics with leading pharmaceutical and biotech companies such as Amgen, AstraZeneca,
Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, and Pfizer.

Benefiting patients and providers

Introduction of the therascreen KRAS test provides an FDA-approved diagnostic
available for making treatment decisions for colorectal cancer patients. Approximately
110,000 colorectal cancer patients each year in the U.S. could benefit from KRAS testing,
according to QIAGEN estimates.

Studies show the U.S. healthcare system could save more than $600 million annually by
avoiding unnecessary use of medicines in colorectal cancer patients through determinations
of their KRAS status. In metastatic colorectal cancer patients for whom standalone surgery
and chemotherapy are insufficient, treatment with an epidermal growth factor receptor
(EGFR) inhibitor has been shown to improve overall survival. However, the presence or
absence of KRAS mutations in tumors affects outcomes: Approximately 60% of patients with
mutation-negative (wild-type) KRAS genes may benefit from anti-EGFR therapy, while 40%
whose tumors have KRAS mutations may not benefit.

The first FDA approval of the therascreen KRAS test pairs this companion diagnostic
with Erbitux(R), a leading EGFR inhibitor marketed in the U.S. by Bristol-Myers Squibb in
partnership with Eli Lilly and its ImClone Systems unit. According to the U.S. product
information for Erbitux(R), KRAS status evaluation using an FDA-approved diagnostic test
is used to determine treatment, and the therascreen KRAS kit is currently the only test
with this status. Based on the FDA approval for use in metastatic colorectal cancer
patients, the current annual U.S. market potential for sales of the therascreen KRAS kit
in this indication only is approximately $20 million.

In contrast to laboratory-developed tests (LDTs), the FDA-approved therascreen KRAS
test gives healthcare providers a fast, consistent and reliable process to determine
optimal treatment for colorectal cancer patients who are candidates for EGFR-inhibitor
therapy. The therascreen KRAS kit has been shown to have higher sensitivity (i.e. a lower
limit of detection, LOD) for KRAS mutations between 0.8% and 6.4% depending on the assay
which is critical to ensuring reliable and consistent data for treatment decisions.

Following FDA approval, a number of laboratories will begin offering KRAS status
evaluation with the therascreen KRAS test

        - Applied Diagnostics, Inc.
        - Boyce & Bynum Pathology Laboratories
        - Cellnetix Pathology & Laboratories
        - Clinical Molecular Oncology Laboratory, The University of Kansas Medical
        - Colorado Molecular Correlates Laboratory (CMOCO), University of Colorado
        - Companion Dx Reference Lab, LLC
        - Dahl-Chase Diagnostic Services
        - Lab21 Inc.
        - Mayo Clinic

For more details and actual status visit http://www.qiagen.com/therascreen.

Adding value to QIAGEN’s automation platforms

In line with QIAGEN’s strategy of driving platform success, the therascreen KRAS test
offers laboratories an efficient workflow based on the Rotor-Gene Q MDx, an automated
molecular detection instrument that uses real-time PCR technology. All other companion
diagnostics in development, as well as a range of other molecular diagnostic tests, are
being developed for U.S. regulatory approval on the Rotor-Gene Q MDx.

The therascreen KRAS kit is the second assay cleared/approved by the FDA for use on
the Rotor-Gene Q MDx. Earlier in 2012, QIAGEN’s artus Infl A/B RG RT-PCR for the detection
of Influenza A/B was cleared for use on Rotor-Gene Q MDx, with the instrument also
receiving FDA 510(k) clearance at the same time.


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 March 31, 2012,
QIAGEN employed approximately 3,900 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).


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



        Investor Relations:
        John Gilardi
        VP Corporate Communications

        Albert F. Fleury
        Investor Relations North America
        Email: ir@qiagen.com



Source: PR Newswire