Sera Prognostics (SERA) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Industry context and problem

• Preterm birth rates in the US have risen from 9.4% in 2013 to 10.4% in 2023, with 1 in 10 babies born prematurely and significant health and economic impacts, as 10% of babies account for 61% of neonatal costs.

• Most preterm births occur in women without known risk factors, making prediction and prevention challenging.

• Existing guidelines only identify a small subset of at-risk pregnancies, leaving 88% classified as low risk.

Technology and solution

• The PreTRM test uses mass spectrometry to measure the ratio of two proteins (IBP4 and SHBG) in maternal blood, predicting preterm birth risk in asymptomatic singleton pregnancies at 18–20 weeks gestation.

• The test is accessible via physician offices or at-home kits, with results delivered in 3–5 days and actionable recommendations for providers.

• A three-pronged intervention (nurse calls, low-dose aspirin, vaginal progesterone) is offered to high-risk patients, enabling targeted care management.

Clinical validation and outcomes

• Large multicenter trials (AVERT, PRIME) showed PreTRM-guided interventions reduce neonatal morbidity, mortality, NICU admissions, and hospital length of stay, including a 7-day reduction in neonatal hospital stay and 18% reduction in severe morbidity for high-risk babies.

• The pivotal PRIME study, halted early for success, demonstrated a 25% reduction in health complications, 18% reduction in NICU length of stay, and 22% reduction in NICU admissions, with one in five babies avoiding NICU entirely.

• Patient and provider testimonials highlight improved outcomes and empowerment through proactive risk management.