Netherlands holding company Qiagen has acquired AmniSure International, 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. Financial terms 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.

"We are very pleased to bring the AmniSure assay into our emerging portfolio of solutions for Point of Need diagnostics,” said Peer Schatz, CEO of Qiagen. “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.” Qiagen already offers Qiagen ESE Quant Lateral Flow Readers and Tube Scanners as Point of Need diagnostics.

AmniSure is a diagnostic test for ROM cleared by the FDA for marketing and is reimbursable under most U.S. state Medicaid plans. 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.