On April 20, 2018, Qiagen announced the FDA approval of the novel test named PartoSure^TM, used for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.

Since the FDA had also given pre-market approval of PartoSure^TM, its commercialization will begin much sooner across Europe, the Middle East, Asia and Latin America.

 The rapid and accurate PartoSure^TM was considered a milestone in the development of diagnostic tests for preterm birth. It is a non-invasive strip test which provides higher positive results within five minutes, compared to other diagnostic methods. The PartoSure^TM test detects the presence of placental alpha microglobulin-1 (PAMG-1) in preterm labor patients.

The PartoSure^TM test also includes the AmniSure® ROM test, the world’s leading assay for non-invasive prenatal testing (NIPT). The combination of both PartoSure^TM and AmniSure act as biomarker targeted diagnostic assays which are meant for assessing the risk of prenatal labor management. Both tests are user-friendly and one can easily analyze the results without the help of a reader. PartoSure^TM test was more reliable due to reductions in unwanted hospitalizations and therapies.

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