QIAGEN N.V. has 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.