Qiagen wins FDA nod for point-of-care PartoSure test

Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor.

The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen.

Beyond the company’s U.S. regulatory win, PartoSure is approved and commercialized in Europe, the Middle East, Asia and Latin America.

“Preterm birth is a global condition that has a dramatic impact in the United States, where about one in 10 babies are premature and the cost of preterm births and complications is estimated at more than $26 billion a year. The FDA-approved PartoSure test will help clinicians assess which mothers face an imminent risk of preterm birth, which should reduce healthcare costs and benefit patients,” Thierry Bernard, SVP & head of Qiagen’s molecular diagnostics division, said in prepared remarks.

Bernard noted that a significant number of pregnant women experience the symptoms of preterm labor, but only a portion of them go on to give birth prematurely.

“Clinicians struggle to predict which symptomatic women will give birth prematurely and to decide on appropriate care. Discharging these patients carries a risk of a preterm delivery outside of the hospital, but admitting them always incurs considerable costs and disruptions to the family – often unnecessarily. PartoSure has been proven to reduce the uncertainty,” Bernard added.

In one study published last year in Ultrasound in Obstetrics and Gynecology, researchers evaluated PartoSure’s performance compared to fetal fibronectin tests in real-world practice. They found that a positive PartoSure test was four times as reliable as a positive fetal fibronectin test in predicting preterm birth, according to Qiagen.

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