Qiagen has acquired AmniSure International, the US-based medical device company responsible for the commercialisation of the AmniSure assay for determining whether a pregnant woman is suffering rupture of fetal membranes (ROM).

Approved by the US Food and Drug Administration (FDA), AmniSure is a one-step, minimally invasive test strip that uses proprietary technology to detect tiny quantities of amniotic fluid in vaginal discharge.

Qiagen chief executive officer Peer Schatz said the accurate diagnostic test contributes to the management of pregnancy and adds to the company’s portfolio of tests and in particular, for the obstetrics and gynecology (OB / GYN) market that also includes digene HPV tests.

"Our clinical sales force in the US, 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," Schatz added.

AmniSure International president and chief executive officer Michael Friedman said the transaction and the synergies with Qiagen’s sales force offer opportunities to accelerate growth in the US and overseas.

Qiagen anticipates the acquisition to be neutral to adjusted diluted earnings per share (EPS) in 2012, but to be accretive by approximately $0.02 in 2013 and is also likely to contribute around $12m for the rest of 2012 and full-year sales of about $24m in 2013.

Financial terms of the agreement have not been disclosed.

The false-positive diagnosis of ROM can lead to unnecessary hospital admissions, induction of labour pain and use of medications.

Qiagen is a provider of sample and assay technologies that are used to isolate and process DNA, RNA and proteins from biological samples, such as blood or tissue, to make them ready for interpretation.