FDA Greenlights PartoSure to Assess Spontaneous Preterm Birth Risk

Qiagen NV has announced the regulatory approval by the US Food and Drug Administration (FDA) of PartoSure, a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.

PartoSure received approval based on several studies that demonstrated a higher positive predictive value for preterm birth versus current diagnostic methods while maintaining an equally high negative predictive value.

“The FDA-approved PartoSure test will help clinicians assess which mothers face an imminent risk of preterm birth, which should reduce health care costs and benefit patients,” Thierry Bernard, senior vice president, head of the molecular diagnostics business area, Qiagen, said in a statement. “While a significant number of pregnant women experience symptoms of threatened preterm labor, as few as 3% actually progress to giving birth within a week of testing.”

The noninvasive strip test detects placental alpha macroglobulin in patients presenting with signs and symptoms of preterm labor, providing results in 5 minutes or less.

“Clinicians struggle to predict which symptomatic women will give birth prematurely and to decide on an appropriate care,” Bernard concluded. “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.”

The most recently published study of PartoSure concluded that a positive test was significantly better at assessing the risk for preterm birth among symptomatic women than a fetal fibronectin test—the only other FDA-approved test to assess the risk of preterm delivery.

Study authors emphasized several practical advantages of the PartoSure test that includes the capability to rapidly test specimens collected after prior intercourse of vaginal examination, without requirement for a speculum examination or the need to read the test on an instrument.

In another study, researchers compared the performance of PartoSure to fetal fibronectin tests in a real-world clinical practice and concluded that a positive PartoSure test was more than 4 times as reliable as a positive fetal fibronectin test.

The pre-market approval comes on the heels of the rapid uptake of the quick, precise test in more than 35 countries across Europe, the Middle East, Asia and Latin America.

Commercialization of the test in the US is expected to begin this year.