The firm has launched a 2,300-subject prospective study evaluating the test, which measures exosome proteins to assess a woman's risk of preterm delivery.
Milu will help launch the test in countries including China as it works to develop a diagnostics business in Asia targeting maternal and women's health.
With the approval Sera is permitted to provide lab testing services ordered by a medical professional for use by pregnant women in all US states.
NX Prenatal and Indiana University School of Medicine are collaborating to develop exosome blood tests for preterm birth risk and preeclampsia.
Based on the level of 25 serum markers, the test is meant to assess risk of both spontaneous preterm delivery and deliveries indicated by an underlying condition.
PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients and is already being used in 35 countries in Europe, the Middle East, Asia, and Latin America.
Recently-funded research aims to develop a rapid test that combines immunoassay and miRNA detection with magnetic nanosensors.
They acknowledge that while the technical hurdles of proteomic test development have become manageable, commercialization is still a major challenge.
The researchers said that better diagnostics are needed to distinguish between false preterm labor and true preterm labor to prevent unnecessary treatment.
The researchers are developing a clinical assay that would use multiple biomarkers to analyze low-abundance peptides indicative of preterm risk.