Qiagen acquires AmniSure International, adds assay to Point of Need portfolio

Qiagen NV 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 foetal 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 - 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. On the other hand, false-positive diagnosis of ROM can lead to inconvenient and expensive outcomes such as unnecessary hospital admissions, induction of labour and use of medications.

AmniSure is a point-of-need test that provides quick and highly reliable results in an emergency room, birthing centre or clinic. It is a one-step, minimally invasive test strip which detects tiny quantities of amniotic fluid in vaginal discharge. Results are available in minutes and accuracy of the test approaches 99% - far superior to traditional methods.

“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,” said Peer Schatz, CEO of Qiagen NV.

QIAGEN expects the growth impulses from offering this product to be catalytic to its small but growing point-of-need portfolio, which is serving 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 organisation. 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 US and overseas,” said Dr Michael Friedman, President and CEO of AmniSure International.

Financial terms of the agreement to acquire AmniSure, which is expected to contribute approximately $12 million to Qiagen for the remainder of 2012, were not disclosed. 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.