FDA approves a bedside test for assessing the risk of spontaneous preterm birth

QIAGEN won FDA approval for marketing its Novel PartoSure® point of care test for estimating the risk of spontaneous preterm birth in patients who present with symptoms of preterm labor. PartoSure represents a breakthrough in research and development of diagnostic tests for preterm birth.

Predicting preterm birth is a diagnostic challenge and nearly 85% of patients admitted to the hospital for threatened preterm labor (PTL) do not deliver within the next 7 days, resulting in unnecessary interventions.

This non-invasive strip test provides results in just 5 minutes or less and can be done at patient’s bedside. The sample collection procedure is simple and does not require a speculum examination or specialized equipment for sample analysis.

The PartoSure test is a rapid, qualitative test and detects the presence of placental alpha microglobulin-1 (PAMG-1) in cervicovaginal secretions. A positive test indicating that delivery is imminent within 7 days in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (<3 cm), between 24 weeks, 0 days and 34 weeks, 6 days gestation with a singleton gestation. 

Several studies have reported a higher positive and negative predictive value for PartoSure, as compared to other existing diagnostic tests. Furthermore, a positive PAMG-1 test was more than four times more reliable than a positive fFN test in predicting imminent spontaneous preterm delivery according to a study published August 2017 in Journal of Ultrasound in Obstetrics and Gynecology.

According to the American College of Obstetricians and Gynecologists (ACOG) 2016 Practice Bulletin on Management of PTL, the positive predictive value of a positive fetal fibronectin test result or a short cervix alone is poor and should not be used exclusively to direct management in the setting of acute symptoms.

The market approval of PartoSure adds to the already burgeoning QIAGEN’s comprehensive Sexual and Reproductive Health portfolio which includes AmniSure® ROM Test, the world’s leading assay for rupture of membranes (ROM), besides many others.

The combination of PartoSure and AmniSure gives QIAGEN two highly synergistic, biomarker targeted diagnostics for assessing the risk of two critical aspects of prenatal labor management. Both tests are leveraging the ability to assess respective risks quickly without the requirement of a reader.

“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,” said Thierry Bernard, Senior Vice President and head of QIAGEN’s Molecular Diagnostics Business Area in a press release. “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. 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."

PartoSure has already been in the market in more than 35 countries across Europe, the Middle East, Asia and Latin America and is expected to be available in the U.S. in 2018.

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QIAGEN Press Release 

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Here is a video of the PartoSure Test

PartoSure IFU Video from PartoSure Test on Vimeo.