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 o
|SOURCE QIAGEN N.V.|
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