Recent Device Approval: PartoSure Test

FDA has recently approved the PartoSure Test to be marketed. The PartoSure test is used to detect the presence of placental alpha microglobulin-1 (PAMG-1), a protein present in the amniotic fluid throughout pregnancy. PAMG-1’s presence in the vaginal cavity of pregnant women carrying only one fetus, who have signs and symptoms of preterm labor, but who do not have ruptured amniotic membranes, may be associated with spontaneous preterm delivery within 7 days of testing. The PartoSure test includes a sterile flocked swab, a vial with an extraction solvent, and a lateral flow test strip.