Qiagen has received US regulatory approval for PartoSure, a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labour. Approval by the US Food and Drug Administration (FDA) follows successful uptake of the rapid test in more than 35 countries across Europe, the Middle East, Asia and Latin America.
PartoSure represents a key milestone in the development of diagnostic tests for preterm birth. A non-invasive strip test that provides results in five minutes or less, PartoSure 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 labour.
PartoSure adds to Qiagen’s comprehensive Sexual and Reproductive Health portfolio, which includes the AmniSure ROM (rupture of membranes) test; differentiated core technologies and bioinformatics solutions for non-invasive prenatal testing (NIPT); and the digene HC2 HPV test to screen for human papillomavirus (HPV).