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

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, 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. 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.


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

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).


Public Relations:
Dr. Thomas Theuringer
Director Public Relations

Investor Relations:
John Gilardi
VP Corporate Communications

Albert F. Fleury
Investor Relations North America

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