Qiagen N.V. / QIAGEN Launches New Automated Modular Testing Platform for Molecular Diagnostics processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
QIAsymphony RGQ System scores with highest possible flexibility and the broadest
available range of PCR-based test systems
Hilden, Germany, and Germantown, MD., September 1, 2010 - QIAGEN N.V. (NASDAQ:
QGEN; Frankfurt Prime Standard: QIA) today launched its novel QIAsymphony RGQ
system. The automated platform has been specifically designed to address the
fast-growing molecular diagnostics market, particularly for applications in
"Profiling" and "Personalized Healthcare"*. It is the only modular system that
covers entire laboratory workflows from the initial sample preparation to the
final result. The QIAsymphony RGQ thereby provides its users with an
unprecedented level of flexibility: Customers can use the new platform not only
to run several existing QIAGEN tests, but also to develop and conduct their own
PCR-based assays.
The QIAsymphony RGQ system is approved for in-vitro diagnostic use in Europe and
launches with several molecular assays for the detection of viruses such as HIV
and Hepatitis, as well as a specific test panel for transplantation medicine.
All of these products from QIAGEN's artus product range have been already
validated for clinical use in connection with the new system.* Numerous other
products will complement the existing test portfolio over the next months. These
products will include tests for biomarkers such as KRAS, EGFR or PI3K in
personalized healthcare applications, assays for the detection of influenza
viruses, as well as a dedicated women's health panel. This will allow diagnostic
and research access to the broadest commercially available PCR-based assay
portfolio in the marketplace.
The system also allows customers to run custom laboratory developed tests (LDT)
which can be validated for clinical use. In molecular diagnostics, laboratory
developed tests account for about 40 percent of the global market volume and for
an even higher share of all existing test parameters. Facing stricter
requirements from regulatory bodies such as the U.S. Food and Drug
Administration (FDA), this sector shows signs of a growing demand for
standardized and clinically proven systems for the development of custom
PCR-based assays. With the QIAsymphony RGQ, developers and users of such tests
gain access to instruments and reagents that match the highest quality and
functionality standards for clinical applications. To date, there are more than
200 such applications that are compatible with the new QIAsymphony RGQ platform.
"The launch of our QIAsymphony RGQ is a very important milestone in further
expanding our leading position in molecular diagnostics", said Peer Schatz,
QIAGEN's CEO. "The integrated and validated system was designed to meet both
current and future needs of molecular diagnostic labs. We will continue to
complement the system not only by expanding the existing assay portfolio, but
also by adding further unique performance features." Future expansions that have
been already announced by the company include the integration of the
Pyrosequencing detection technology and the capability to detect multiple
molecular targets in a single test run, known as Multiplexing.
With an increase of 14 percent, QIAGEN's automation business has seen a strong
revenue growth in the second quarter of 2010. Instrument sales thereby also add
to long-term reagent and consumable sales, which account for 85 percent of the
company's business. QIAGEN has already registered a significant amount of
pre-orders for the QIAsymphony RGQ system.
The QIAsymphony RGQ is composed of three modules: the award winning "QIAsymphony
SP" for sample preparation, the new "QIAsymphony AS" for assay setup, and
QIAGEN's real-time PCR detection platform "Rotor-Gene Q". Two of its unique
features include continuous sample loading and the ability to run different
tests for each sample. These features address a critical requirement in
"Profiling" and "Personalized Healthcare" applications, where laboratories
typically process a variety of different samples such as blood or tissue and
have to test them for different molecular targets.
More information about QIAsymphony RGQ is available on QIAGEN's European
websites at
http://www.qiagen.com/mc/QIAsymphonyRGQ.
* The tests are currently not available in the United States for in-vitro
diagnostic use. They have not been cleared or approved by authorities including
the United States Food and Drug Administration or any other regulatory agency in
the United States for human diagnostic or other clinical use.
About QIAGEN
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/.
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).
Contacts:
Investor Relations: Public Relations:
Dr. Solveigh Mähler Dr. Thomas Theuringer
Director Investor Relations Director Public Relations
QIAGEN N.V. QIAGEN GmbH
+49 2103 29 11710 +49 2103 29 11826
e-mail:solveigh.maehler@qiagen.com e-mail:thomas.theuringer@qiagen.com
Albert F. Fleury
Investor Relations North America
QIAGEN N.V.
+1 301 944 7028
e-mail:albert.fleury@qiagen.com
[HUG#1441807]
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