Qiagen (Hilden, Germany) announced the acquisition of AmniSure International LLC (Boston, MA, USA), a privately owned company. Financial terms of the agreement to acquire AmniSure were not disclosed.

The AmniSure assay determines whether a pregnant woman is suffering rupture of fetal membranes (ROM), a condition in which fluid leaks from the amniotic sac prematurely. The US Food and Drug Administration (FDA; Silver Spring, MD, USA)-cleared AmniSure test is highly synergistic with Qiagen’s clinical sales channels.

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.

ROM is 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.

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.

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 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,” said Peer Schatz, CEO of Qiagen N.V.

Related Links:

Qiagen

AmniSure International LLC

US Food and Drug Administration