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.
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma
FDA approves Dupixent as first targeted therapy for rare skin disease bullous pemphigoid