Sera Prognostics Announces Randomized Trial Finds PreTRM Test Improves Outcomes By Identifying Women At Risk For Preterm Birth

Published in the journal PREGNANCY, the PRIME Study demonstrates significant improvements in neonatal outcomes with early risk screening and targeted interventions.

SALT LAKE CITY, Jan. 7, 2026 /PRNewswire/ -- A randomized controlled trial of 5,018 women has found that a simple blood test, when paired with targeted interventions, can significantly reduce the risk of preterm birth and improve outcomes for newborns. The findings, published in PREGNANCY, the peer-reviewed journal of the Society for Maternal-Fetal Medicine, highlight the effectiveness of the PreTRM Test in identifying women at higher risk for spontaneous preterm birth and guiding preventive care.

Key findings from the PRIME Study include:

• 56% and 32% fewer babies were born before 32 and 35 weeks, respectively
• 20% fewer babies admitted to the NICU
• Fewer health complications for newborns (20% reduction in odds of neonatal morbidity)
• A NICU day was saved for every 4.2 patients screened

The PreTRM Test is a first-of-its-kind, personalized, non-invasive blood test that predicts the risk of spontaneous preterm birth in asymptomatic women carrying a single baby. In the study, women identified by the PreTRM Test as higher risk for preterm birth received daily vaginal progesterone, low-dose aspirin, and nurse-led care management, while lower-risk women and the control group received standard prenatal care.

About Sera Prognostics, Inc.

Sera Prognostics is a health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. The company's PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test for early, individualized risk prediction of spontaneous preterm birth. Sera Prognostics is headquartered in Salt Lake City, Utah.