Announcement • Jul 10

Sera Prognostics, Inc. Announces Subgroup Analysis Results Demonstrating 22% Reduction in NICU Admissions Using Pretrm Test-Guided Care in First-Time Pregnancies

Sera Prognostics, Inc. announced publication of a new subgroup analysis from the PRIME randomized controlled trial. The analysis demonstrated that PreTRM Test-guided care in first-time pregnancies significantly improved neonatal outcomes, including a 22% reduction in neonatal intensive care unit (NICU) admissions. Four in ten U.S. births are to first-time mothers. Traditional risk assessment tools rely heavily on prior pregnancy history, which is not available in this population. The PreTRM Test enables early risk identification, creating an opportunity for early intervention and improved outcomes. The findings, published in The Journal of Maternal-Fetal & Neonatal Medicine, highlight the clinical value of early risk stratification using the PreTRM Test combined with accessible interventions in women in their first pregnancy, a large population in which risk is otherwise difficult to predict. Key Findings from PRIME Primigravid Nulliparous Subgroup (n=1,783): Reduced NICU admissions: 22% overall relative reduction, including a 2-fold reduction among newborns following spontaneous preterm birth. Strong screening efficiency: 28 first-time pregnancies needed to screen and treat to prevent one NICU admission. Healthier newborns: Reduced severe composite morbidity (6.4% vs. 9.1%), representing a 30% relative reduction compared to the blinded control group. In this subgroup of 1,783 nulliparous participants, PreTRM Test-guided care significantly reduced NICU admissions and improved neonatal outcomes compared to routine care. Interventions —including progesterone, low-dose aspirin, and care management— were well tolerated. The screening and treatment approach substantially outperformed traditional methods, supporting its potential as a more effective standard of care in this population without prior birth history. These findings further reinforce the clinical utility of the PreTRM platform in enabling earlier intervention and improving neonatal outcomes. By enabling earlier risk identification, Sera's approach supports broader adoption of effective care strategies across diverse clinical settings. This publication strengthens Sera's growing body of evidence supporting the PreTRM Test as a scalable solution to improve outcomes and reduce healthcare costs. The PreTRM Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM Test is ordered by a medical professional.

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