Test to assess risk of preterm birth approved by the FDA

26th April 2018

QIAGEN N.V.

Enaie Azambuja

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Datasheet

QIAGEN N.V. has announced the U.S. regulatory approval of PartoSure, which is a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labour. The pre-market approval of PartoSure by the FDA follows successful uptake of the rapid, accurate test in more than 35 countries across Europe, the Middle East, Asia and Latin America. U.S. commercialisation of the PartoSure test is expected to begin in 2018.

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 novel test detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor.

PartoSure adds to QIAGEN’s comprehensive Sexual and Reproductive Health portfolio, which includes the AmniSure ROM Test, the world’s leading assay for rupture of membranes (ROM); differentiated core technologies and bioinformatics solutions for non-invasive prenatal testing (NIPT); and the “gold standard” digene HC2 HPV Test to screen for human papillomavirus (HPV) and protect women from cervical cancer.

The combination of PartoSure and AmniSure gives QIAGEN two highly synergistic, biomarker targeted diagnostics for assessing the risk of two critical aspects of prenatal labour management. Both tests are leveraging the ability to assess respective risks quickly without the requirement of a reader.