QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lu

 QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion
    Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients

PR Newswire

HILDEN, Germany and LONDON, July 28, 2014

HILDEN, Germany and LONDON, July 28, 2014 /PRNewswire/ --

  oCollaboration aims to create and commercialize companion diagnostic using
    genomic data from plasma samples to guide the use of IRESSA for non-small
    cell lung cancer patients
  oNew blood test will build on QIAGEN's FDA-approvedtherascreenEGFR test
    and is planned torunon Rotor-Gene Q, member of the QIAsymphony family of
    automated instruments
  oProject enabled by AstraZeneca master framework agreement adds to QIAGEN's
    growing portfolio of liquid biopsy solutions, which complement
    tissue-based testing solutions

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced a
collaboration agreement with AstraZeneca PLC (LSE, NYSE and OMX: AZN) for the
co-development and commercialization of a liquid biopsy-based companion
diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for
non-small cell lung cancer (NSCLC). The project builds on a master framework
agreement signed by both companies in 2013 and aims to develop and market a
novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR
mutation status in NSCLC patients. The assay will be designed to guide the
treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer
treatment when tumour tissue is not available. QIAGEN already offers the
therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based
companion diagnostic for lung cancer patients, which was approved in the U.S.
by the FDA in July 2013 and in China in May 2014.

The companies will collaborate to create a new companion diagnostic for IRESSA
based on liquid biopsy samples from NSCLC patients, rather than requiring
invasive surgical collection of tissue samples. Data from several studies,
including the IFUM Study (IRESSA Follow-up Measure) presented at the "World
Lung 2013" conference, provided evidence of the ability to assess the EGFR
status of advanced lung cancer patients using blood / plasma samples. This
breakthrough provides hope for patients for whom surgical biopsy is not an
option by enabling them to have their EGFR mutation status assessed using a
less invasive method.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology
at AstraZeneca, said: "By combining AstraZeneca's expertise in lung cancer
with QIAGEN's diagnostic capabilities, we have the potential to transform the
way specific tumour types are identified and treated. The use of circulating
tumour DNA testing will allow doctors to target the individual needs of each
patient quickly and accurately."

"We are very pleased to collaborate with AstraZeneca in developing this new
tool to improve life for lung cancer patients. This collaboration will further
expand QIAGEN's rapidly growing portfolio of liquid biopsy solutions for
personalized healthcare which paves a path for patient monitoring using blood
tests for future QIAGEN therascreen companion diagnostics. We are changing the
treatment landscape with highly reliable genomic tests based on blood samples
or other body fluids, providing physicians and patients with additional
options to determine treatments and monitor progress," said Peer M. Schatz,
Chief Executive Officer of QIAGEN. "This new project with AstraZeneca under
our master collaboration agreement, one of several such Pharma partnerships,
adds to our expanding portfolio of reliable companion diagnostics which are
creating valuable test content for the QIAsymphony family of automated
instruments. As tests are developed, commercialization is accelerated through
the established network of laboratories already using assays in QIAGEN's
industry-leading portfolio of companion diagnostics."

IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK)
inhibitor that acts to block signals for cancer cell growth and survival.
Certain EGFR gene mutations occur in a significant number of lung cancers, and
these mutation-positive tumours are particularly sensitive to IRESSA. QIAGEN
and AstraZeneca plan to develop a test that detects 21 EGFR mutations to
identify patients most likely to benefit from the therapy, adapting QIAGEN
technologies from the FDA-approved therascreen^® EGFR RGQ PCR Kit. The new
test kit is planned to run on QIAGEN's Rotor-Gene Q system, a member of the
QIAsymphony family of automated instruments.

QIAGEN is at the forefront in developing and validating companion diagnostics
to guide the selection of medicines in treating cancer and other diseases. In
the United States, QIAGEN received FDA approvals in 2012 and 2014 for the
therascreen^® KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the
therascreen EGFR test in NSCLC. Last month, QIAGEN announced a collaboration
with Lilly to develop companion diagnostics for simultaneous analysis of DNA
and RNA biomarkers in common cancers. Earlier this year, QIAGEN entered into a
collaboration with Exosome Diagnostics to develop first-in-class, non-invasive
diagnostics for key genetic biomarkers in lung and other cancers. QIAGEN's
leading portfolio of liquid biopsy technologies also includes the QIAamp
Circulating Nucleic Acid Kit, which is considered to be the gold standard
sample technology for the processing of free circulating DNA and RNA, as well
as the REPLI-g product line, which enables genomic analysis from single cells.

About QIAGEN

QIAGEN N.V. is a Netherlands holding company publically traded on NASDAQ and
Frankfurt Prime Standard. The Company is the leading global provider of Sample
& Assay Technologies that are used to transform biological materials into
valuable molecular insights. 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, 2014, QIAGEN employed more than 4,000 people in
over 35 locations worldwide. Further information can be found at
http://www.qiagen.com

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialization of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: http://www.astrazeneca.com.

Certain of the statements contained in this news release may be considered
forward-looking statements within the meaning of Section 27A of
theU.S.Securities Act of 1933, as amended, and Section 21E of
theU.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 inapplied testing,
personalized healthcare, clinical research,proteomics, women's
health/HPVtesting andnucleic acid-basedmolecular 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, theU.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

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

SOURCE Qiagen
 
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