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Qiagen N.V. (0H1Z)

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Tuesday 11 November, 2008

Qiagen N.V.

QIAGEN Introduces CE-marked Molecular Assay for...

  Pyrosequencing-based molecular test detects and profiles genetic
    mutations to predict responses to EGFR inhibitor therapies in
                     colorectal cancer patients

Venlo, The Netherlands  - November  10, 2008 -  QIAGEN N.V.  (NASDAQ:
QGEN; Frankfurt Prime Standard: QIA) today announced the launch of  a
new test to determine mutations of the K-ras gene. The K-ras gene  is
mutated in between 35 percent and 45 percent of metastatic colorectal
cancer (CRC)  patients. Studies  have shown  that K-ras  testing  can
better define which  CRC patients  will benefit  from treatment  with
epidermal  growth  factor   receptor  (EGFR)  inhibiting   monoclonal
antibodies,   such   as    Amgen's   Vectibix®   (panitumumab)    and
Imclone/Bristol-Myers Squibb's Erbitux® (cetuximab).

QIAGEN's new "PyroMark Q24 K-ras  Assay-Kit" is CE-marked for use  in
second-line treatment  of metastatic  CRC  together with  Erbitux  or
Vectibix and will  be available  near the beginning  of 2009.  QIAGEN
intends to  launch this  assay for  in vitro  diagnostic use  in  the
United States as well. QIAGEN's new "PyroMark Q24 K-ras Assay-Kit" is
able to  detect all  major and  minor known  mutations in  the  K-ras
codons 12, 13 and 61, and,  in addition, allows the discovery of  new
mutations as well. This assay is the first molecular assay QIAGEN  is
launching based  on  Pyrosequencing,  a  fundamental  technology  for
short-length, high resolution  sequence analysis and  quantification.
QIAGEN acquired the technology and the associated business in October
2008 from Biotage.

"The design  and performance  of this  assay demonstrates  the  great
potential which Pyrosequencing has for molecular testing in  research
and  molecular  diagnostics  and   underscores  the  value  of   this
technology as an integral part of our assay and detection portfolio",
says Peer Schatz, CEO of QIAGEN. "Unlike other technologies routinely
used in molecular diagnostics (such as PCR), Pyrosequencing reads the
actual target sequence.  While PCR can  only detect known  sequences,
Pyrosequencing can detect all known and unknown genetic variations in
all DNA target  regions in which  mutations occur -  and this all  at
very attractive prices, with built  in quality control, in  multiplex
formats and even from the most challenging starting materials such as
fixed tissue."

The market for K-ras testing has  seen strong momentum over the  last
months. A number  of recently  published studies,  including a  large
multinational prospective study conducted  by the Belgian  University
in Leuven, suggested that the  K-ras mutation status is a  prognostic
biomarker predicting the  outcome of EGFR  therapies. In this  study,
approximately 40% of  all CRC-patients had  mutated K-ras genes.  The
trial data indicated that such patients will not benefit from, and in
some cases  even experience  negative reactions  to EGFR  antibodies,
while patients without specific mutations are likely to benefit  from
this drug treatment.

In  response  to  these  studies,  European  regulators  adopted  the
indication for Vectibix (panitumumab) to include only patients  whose
tumours carry the unmutated K-ras gene. Earlier this month, the  U.S.
National Comprehensive Cancer  Network (NCCN)  issued new  guidelines
for treatment  of  CRC  which recommended  that  only  patients  with
tumours characterized by  the unmutated K-ras  gene shall be  treated
with EGFR drugs. This organization  of 21 cancer centres  furthermore
recommended that  oncologists should  generally determine  the  K-ras
gene  status  of  all  patients  diagnosed  with  CRC  prior  to  any
For the  future,  experts  also expect  the  inclusion  of  molecular
diagnostic tests  for  K-ras  testing as  companion  tests  for  EGFR
treatment of other cancers, such  as lung adenocarcinomas or  thyroid
cancer. "Routine K-ras testing can help to define the most  effective
treatment for  cancer  patients",  Mr.  Schatz  added.  "Personalized
medicine will without doubt further  shape the future of  healthcare.
It enables physicians  to customize therapies  for effectiveness  and
efficiency,  it   greatly   reduces  healthcare   costs   and,   most
importantly, it can  contribute to  the avoidance  of unnecessary  or
even  harmful  treatments   for  patients   suffering  from   serious
diseases". QIAGEN already offers a large portfolio of pharmacogenetic
sample and assay technologies  which includes, subject to  regulatory
approval  in   various   countries,  molecular   tests   related   to
transplantation  and  therapies  related  to  cancer  and  infectious

About K-ras:
K-ras is an oncogene which plays  a crucial role for the  development
of  tumours.  Mutations   in  the  ras   family  of   proto-oncogenes
(comprising H-ras, N-ras and K-ras)  are very common, being found  in
up to 30% of all human tumors.  Due to a mutation of the K-ras  gene,
cancer cells continue to grow and divide. Mutant K-ras is present  in
approximately 35-45 percent of  colorectal cancers, in 15-50  percent
of lung  cancers and  in  72-90 percent  of pancreatic  cancers.  The
mutations have been localized in various DNA sections, in codons  12,
13, 59 and 61. Several recently published studies have shown that the
mutation status can be  a prognostic marker  for treatment with  EGFR
antibodies such as  Erbitux® and  Vectibix®. By  knowing a  patient's
K-ras mutation status,  oncologists are  able to  identify whether  a
patient can  benefit from  treatment with  these antibodies  and  can
individualize cancer therapy for these patients.

QIAGEN   N.V.,    a    Netherlands   holding    company,    is    the
leading global provider of  sample  and  assay  technologies.  Sample
technologies are used to  isolate and process  DNA, RNA and  proteins
from biological samples such  as blood or tissue. Assay  technologies
are used  to  make such  isolated  biomolecules visible.  QIAGEN  has
developed and markets more  than 500 consumable  products as well  as
automated solutions  for such  consumables. The company provides  its
products to molecular diagnostics laboratories, academic researchers,
pharmaceutical   and    biotechnology    companies,    and    applied
testing customers for  purposes such  as forensics,  animal  or  food
testing   and   pharmaceutical   process   control. QIAGEN's    assay
technologies  include  one  of  the  broadest  panels  of   molecular
diagnostic tests available  worldwide. This panel  includes the  only
FDA-approved test for human  papillomavirus (HPV), the primary  cause
of cervical cancer. QIAGEN employs more than 2,900 people in over  30
locations worldwide. Further information about QIAGEN can be found at

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   are
forward-looking, such statements  are based  on current  expectations
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   and  risks  of  dependency   on
logistics),  variability   of  operating   results,  the   commercial
development of the applied testing markets, clinical research markets
and proteomics  markets,  nucleic  acid-based  molecular  diagnostics
market,  and   genetic   vaccination  and   gene   therapy   markets,
competition,   rapid   or   unexpected   changes   in   technologies,
fluctuations in demand for QIAGEN's, products (including fluctuations
due to the level and timing of customers' funding, budgets, and other
factors), our ability to obtain regulatory approval of our infectious
disease  panels,  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  its  products   from  competitors'  products,   market
acceptance of QIAGEN's new products  and the integration of  acquired
technologies and businesses.  For further information,  refer to  the
discussions in reports that QIAGEN  has filed with, or furnished  to,
the U.S. Securities and Exchange Commission (SEC).


Dr. Solveigh Mähler                      Dr. Thomas Theuringer
Director Investor Relations              Associate Director Public
QIAGEN N.V.                              Relations
+49 2103 29 11710                        QIAGEN GmbH
e-mail:                                  +49-2103-29-11826
[email protected]              email:
                                         [email protected]
Albert F. Fleury
Director Corporate Finance and
Investor Relations North America
QIAGEN Gaithersburg, Inc.
+1 301 944 7028
e-mail: [email protected]

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