QIAGEN and Exosome Diagnostics to Develop First-In-Class, Non-Invasive Diagnostics for Key Genetic Biomarkers in Lung and Other Cancers

January 13, 2014

GERMANTOWN, Maryland, and HILDEN, Germany, January 13, 2014 /PRNewswire/ –

        - Expanding collaboration to develop FDA-regulated diagnostics based on
          exosomes to measure gene mutations targeted by new anti-cancer therapies
        - Non-invasive detection of biomarkers from blood reduces patient risk and
          advances access to the benefits of personalized medicine
        - Automated biofluid-based molecular diagnostics have significant potential to
          replace many costly and invasive tissue biopsies and add new testing options
        - QIAGEN set to launch during 2014 the first in a series of new sample
          preparation kits for processing nucleic acids from biofluid exosomes

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced an expansion
of its strategic partnership with Exosome Diagnostics Inc. to develop a first-in-class,
non-invasive molecular in-vitro diagnostics for use in diagnosing and monitoring patients.
The novel blood based diagnostic detects certain mutations of an undisclosed gene
associated with non-small cell lung cancer (NSCLC) and other malignancies and has the
potential to be paired with several new anticancer therapeutics. QIAGEN will have
worldwide exclusive rights for commercialization and intends to submit the test to the
U.S. Food and Drug Administration (FDA) following clinical validation. Financial terms
were not disclosed.

Exosomes are the messenger packages in a fundamental biological communication system
that transmits genetic instructions from cell to cell. The technology developed by Exosome
Diagnostics allows non-invasive detection of key disease associated gene mutations and
gene expressions in blood, urine and cerebrospinal fluid without the need for a risky and
burdensome surgical tissue biopsy. The integration of Exosome Diagnostics’ technology with
QIAGEN’s proven sample technologies is expected to create cost effective, easy-to-use and
automated sample-to-result workflows for clinical research and healthcare.

In 2013, QIAGEN and Exosome Diagnostics announced plans to launch the first in a
series of high-performance sample preparation kits for processing nucleic acids from
biofluid exosomes during the second quarter of 2014.

“We are excited about this new testing option, which has the potential to expand our
existing and future assay portfolio,” said Peer M. Schatz, Chief Executive Officer of
QIAGEN. “Biofluid-based tests can significantly increase the value of molecular
diagnostics in diseases that currently depend on tissue biopsies. We look forward to our
expanded collaboration with Exosome and to create solutions for healthcare and science
which can improve lives.”

James McCullough, Chief Executive Officer of Exosome Diagnostics, said: “The ability
to perform molecular diagnostic tests on easily accessible biofluids represents an
important advance in personalized medicine. It will allow physicians to follow patient’s
disease status more closely and to provide the best possible treatment. QIAGEN is the
ideal partner to bring robust, regulated exosome technology products to the global
clinical market place.”

About Exosomes

Exosomes and other microvesicles are a key part of the body’s complex communication
system, transferring genetic instructions between cells. Shed under both normal and
pathological conditions, they can be isolated from biofluids such as blood, urine and
cerebrospinal fluid. Exosomes carry nucleic acids (RNA and DNA) and proteins from their
host cells and are widely considered to be an essential new source for biomarker discovery
for use in personalized healthcare diagnostics. Tumor cells, for instance, release
exosomes which contain tumor-specific RNAs that can be isolated from blood and urine
instead of from biopsies. Exosome Diagnostics’ proprietary technology makes use of the
presence and stability of nucleic acids in exosomes and other microvesicles to detect and
measure levels of genes in biofluids normally only accessible through tissue biopsy and
determine implications in cancer, neurodegenerative, metabolic, infectious and other


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 September 30, 2013, QIAGEN
employed more than 4,100 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
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
, personalized healthcare, clinical research, proteomics
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
, women’s health/HPV
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
testing and nucleic acid
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
-based molecular diagnostics
[http://www.qiagen.com/About-Us/Press-Releases/PressReleaseView/?PressReleaseID=405&lang=EN ]
; 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
        +49 2103 29 11826

        Email: pr@qiagen.com



        Investor Relations:
        John Gilardi
        Vice President Corporate Communications and Investor Relations

        Email: ir@qiagen.com


SOURCE Qiagen N.V.

Source: PR Newswire

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