24 April 2018 - - Hilden, Germany-based Qiagen N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) has received US regulatory approval of PartoSure, which is a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor, the company said.
The pre-market approval of PartoSure by the US Food and Drug Administration follows successful uptake of the rapid, accurate test in more than 35 countries across Europe, the Middle East, Asia and Latin America.
PartoSure, a non-invasive strip test that provides results in five minutes or less, has been shown in several published studies to have a higher positive predictive value for preterm birth compared to current diagnostic methods, while maintaining an equally high negative predictive value.
The test detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor.
Qiagen's comprehensive sexual and reproductive health portfolio includes PartoSure and the AmniSure ROM Test, an assay for rupture of membranes; differentiated core technologies; bioinformatics solutions for non-invasive prenatal testing; and the digene HC2 HPV test to screen for human papillomavirus and protect women from cervical cancer.