PartoSure (Qiagen), a noninvasive test strip test to assess a woman’s risk of spontaneous preterm birth, has been granted pre-market approval by the Food and Drug Administration (FDA). 

The test, already approved in 35 countries, detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor. The FDA approval is based on results from several studies, including a recent study published in the journal Ultrasound in Obstetrics & Gynecology. This study compared the performance of PAMG-1 to fetal fibronectin (fFN) tests (the only other FDA approved test available for preterm birth risk). 

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Results showed that a positive PAMG-1 test was ≥4 times more reliable than a positive fFN test in predicting imminent spontaneous preterm delivery. “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, SVP and head of Qiagen’s Molecular Diagnostics Business Area.

Qiagen expects to begin commercialization of the test at some point in 2018. 

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