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Last updated on May 22, 2013 at 5:44 EDT

QIAGEN Acquires AmniSure International to Add Unique Assay to Emerging Point of Need Portfolio

May 3, 2012

HILDEN, Germany and GERMANTOWN, Maryland, May 3, 2012 /PRNewswire/ –

        - QIAGEN expands Point of Need portfolio with unique AmniSureassay to detect
          rupture of fetal membranes (ROM) - checked in up to 30% of U.S. pregnancies
        - Novel FDA-cleared test is highly synergistic with QIAGEN's clinical sales
          channels

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the
acquisition of AmniSure International LLC [http://www.amnisure.com/site/en ], a privately
owned Boston company that markets the AmniSure assay for determining whether a pregnant
woman is suffering rupture of fetal membranes (ROM), a condition in which fluid leaks from
the amniotic sac prematurely.

As many as 30% of pregnant women are checked in clinical settings for ROM, a
widespread cause of premature delivery and complications requiring admission to neonatal
intensive care units. AmniSure is a Point of Need test that provides quick and highly
reliable results in an emergency room, birthing center or clinic. Obstetricians and
gynecologists (OB/GYNs), who are the primary prescribers of AmniSure in pregnancy, also
routinely screen patients for human papillomavirus (HPV) as part of cervical cancer
prevention testing.

“We are very pleased to bring the AmniSure assay into our emerging portfolio of
solutions for Point of Need diagnostics. This very accurate diagnostic test contributes
significant value in the management of pregnancy and adds to QIAGEN’s portfolio of tests
and in particular for the OB/GYN market that also includes our gold-standard digene HPV
Test [http://www.hpvtest.com ]. Our clinical sales force in the U.S., which primarily
serves the OB/GYN market, offers significant synergies to drive adoption of AmniSure, so
the transaction also adds momentum to our strategic initiative to grow efficiently and
effectively,” said Peer Schatz, Chief Executive Officer of QIAGEN N.V.

QIAGEN further expects the growth impulses from offering this product to be catalytic
to its small but growing Point of Need portfolio, which is led by the QIAGEN ESE Quant
Lateral Flow Readers and Tube Scanners to serve the growing global demand for Point of
Need diagnostics.

“The AmniSure International team is excited about taking our advanced assay to the
next level as part of QIAGEN’s global organization. We are combining with a dynamic
company known for its track record in innovative diagnostic technologies, and the
synergies with QIAGEN’s sales force offer opportunities to accelerate growth in the U.S.
and overseas,” said Dr. Michael Friedman, President and Chief Executive Officer of
AmniSure International.

In the United States, up to 30% of pregnant women are checked in clinical settings for
ROM in their second or third trimesters. Accurate and timely diagnosis is crucial because
the condition, affecting about 10% of pregnant women, is a leading cause of complications
such as maternal or neonatal infections before or after birth. Premature ROM also is
implicated in 25 to 30% of premature births, which carry their own risks. On the other
hand, false-positive diagnosis of ROM can lead to unnecessary hospital admissions,
induction of labor and use of medications – inconvenient and expensive outcomes that
patients, hospitals and healthcare payers seek to avoid.

AmniSure is a diagnostic test for ROM cleared by the FDA for marketing and is
reimbursable under most U.S. state Medicaid plans. The product is also approved in other
markets around the world. The AmniSure test is a one-step, minimally invasive test strip
using proprietary technology to detect tiny quantities of amniotic fluid in vaginal
discharge. Results are available in minutes at the point of care. Accuracy of the AmniSure
test is documented in multiple clinical studies and approaches 99% – far superior to
traditional methods.

Financial terms of the agreement to acquire AmniSure, a privately held company, were
not disclosed. QIAGEN expects this acquisition to be neutral to adjusted diluted earnings
per share (EPS) in 2012, but to be accretive by approximately $0.02 in 2013. The
acquisition of AmniSure is expected to contribute approximately $12 million to QIAGEN for
the remainder of 2012 and full-year sales of approximately $24 million in 2013.
Furthermore, QIAGEN expects to incur one-time charges and integration costs of
approximately $5 million in 2012 which primarily relate to restructuring efforts and
integration activities in connection with the transaction. The closing was completed in
May 2012, upon which AmniSure became a wholly owned subsidiary of QIAGEN and its results
began to be consolidated. AmniSure was advised in this transaction by William Blair &
Company.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample &
Assay Technologies that are used to transform biological materials into valuable molecular
information. 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, 2012,
QIAGEN employed approximately 3,900 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, personalized healthcare, clinical research, proteomics, women’s
health/HPV testing and nucleic acid-based molecular 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, the U.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

http://www.qiagen.com/about/press

        Investor Relations:
        John Gilardi
        VP Corporate Communications
        +49-2103-29-11711
        +1-301-240-686-2222

        Albert F. Fleury
        Investor Relations North America
        +1-301-944-7028
        Email: ir@qiagen.com

http://www.qiagen.com/about/investorrelation

SOURCE QIAGEN N.V.


Source: PR Newswire