QIAGEN Acquires Exclusive Licence for Key PI3K gene

February 8, 2010

VENLO, The Netherlands, February 8 /PRNewswire-FirstCall/ — QIAGEN
(NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its wholly
owned subsidiary DxS has acquired the global and exclusive licence for
biomarker PI3K from Johns Hopkins University to develop real-time-PCR and
endpoint PCR assays. Research has shown that variation in the PI3K gene could
be a key biomarker for use as a companion diagnostic with certain cancer
treatments. The studies suggest that mutations in the PI3K oncogene are
predictive for the success of certain treatments of patients suffering from
lung, breast, colorectal and other cancers. QIAGEN has an active PI3K assay
development and partnering program with pharmaceutical companies to develop
and market tests for new cancer drug candidates. Financial details were not

QIAGEN already markets a PI3K test for research use. This test is based
on real-time polymerase chain reaction (RT-PCR), a widely available
technology to make DNA sequences visible through amplification. The assay,
which uses technology that allows a very significant sensitivity, detects
mutations frequently missed by sequencing methods.

The patent for PI3K mutations in human cancers was initially filed by
researchers at Johns Hopkins who assessed the biomarker during their
evaluation of tyrosine kinase inhibitors targeting the EGFR (Epidermal Growth
Factor Receptor) pathway. Various EGFR inhibiting drugs have shown to be not
effective in cancer patients with mutations in genes of the EGFR pathway
(EGFR, K-RAS, B-RAF etc.). QIAGEN already markets several tests determining
the mutation status in oncogenes. This portfolio includes tests for mutations
of K-RAS and B-RAF, which are indicative for metastatic colorectal, lung and
other cancers. The K-RAS test is CE-marked for companion diagnostic use with
EGFR inhibitors Vectibix(R) and Erbitux(R) and is expected to be submitted
for FDA approval shortly.

“This license agreement is another step forward for QIAGEN and for the
use of novel therapeutics that rely on the widespread availability of the
required PI3K companion diagnostic test”, said Peer M. Schatz, CEO of QIAGEN.
“We are looking forward to developing drug-diagnostic combinations together
with pharmaceutical partners for the selection of the right patient for the
right medicine. This concept allows cancer patients to receive better
treatments and can support healthcare systems to provide the most useful
therapies in cost effective ways.”

QIAGEN is active in more than 15 partnerships with pharmaceutical and
large biotech companies in the field of personalized healthcare, including
AstraZeneca, Merck, Amgen, Lilly, Boehringer-Ingelheim and Pfizer. QIAGEN has
developed and markets approximately 20 companion diagnostics assays in
personalized healthcare and has a strong pipeline targeting to further expand
this leading franchise.

About Companion Diagnostics (CDx)

Companion Dx are integral to the part of personalized healthcare which
allows physicians to determine patients’ potential responses to drug
treatment. These diagnostic tests are developed together with drugs for
particular populations. By testing for specific genetic variations related to
certain biomarkers, health professionals can customize their treatments to
achieve the best possible therapeutic results and avoid unnecessary


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
bio-molecules visible. QIAGEN has developed and markets more than 500 sample
and assay 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 digene HPV Test, which is regarded as a “gold standard” in
testing for high-risk types of human papillomavirus (HPV), the primary cause
of cervical cancer, as well as a broad suite of solutions for infectious
disease testing and companion diagnostics. QIAGEN employs more than 3,500
people in over 30 locations worldwide. Further information about QIAGEN can
be found at http://www.qiagen.com/.


Statements contained in this release that are not historical facts are
forward-looking statements, including statements about our products, markets,
strategy and operating results. Such statements are based on current
expectations that involve risks and uncertainties including, but not limited
to, those associated with: management of growth and international operations
(including currency fluctuations and logistics), variability of our operating
results, commercial development of our markets (including applied testing,
clinical and academic research, proteomics, women’s health/HPV testing,
molecular diagnostics, personalized healthcare and companion diagnostics),
our relationships with customers, suppliers and strategic partners,
competition, changes in technology, fluctuations in demand, regulatory
requirements, identifying, developing and producing integrated products
differentiated from our competitors’ products, market acceptance of our
products, and integration of acquired technologies and businesses. For
further information, refer to our filings with the SEC, including our latest
Form 20-F. Information in this release is as of the date of the release, and
we undertake no duty to update this information unless required by law.


    Dr. Solveigh Mahler
    Director Investor Relations
    e-mail: solveigh.maehler@qiagen.com

    Albert F. Fleury
    Director Corporate Finance and
    Investor Relations North America
    e-mail: albert.fleury@qiagen.com

    Dr. Thomas Theuringer
    Associate Director Public Relations
    email: thomas.theuringer@qiagen.com

    Joanne Cross
    Marketing Manager
    DxS - a QIAGEN Company
    Phone: +44(0)7540-121-673
    Email: joanne.cross@qiagen.com


Source: newswire

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