FDA Approves Qiagen’s PartoSure for Preterm Labor

May 17, 2018  Source: Ddu 220

On April 20, 2018, Qiagen announced the FDA approval of the novel test named PartoSureTM, 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 PartoSureTM, its commercialization will begin much sooner across Europe, the Middle East, Asia and Latin America.

 The rapid and accurate PartoSureTM 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 PartoSureTM test detects the presence of placental alpha microglobulin-1 (PAMG-1) in preterm labor patients.

The PartoSureTM test also includes the AmniSure® ROM test, the world’s leading assay for non-invasive prenatal testing (NIPT). The combination of both PartoSureTM 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. PartoSureTM 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.”

By editor