PRIME SUBGROUP ANALYSIS DEMONSTRATES 22% REDUCTION IN NICU ADMISSIONS IN FIRST-TIME PREGNANCIES USING PreTRM® Test-GUIDED CARE
Rhea-AI Summary
Sera Prognostics (Nasdaq:SERA) reported new PRIME trial subgroup results showing PreTRM® Test-guided care in first-time pregnancies reduced NICU admissions by 22% and severe neonatal morbidity by 30% versus blinded control.
Among 1,783 nulliparous participants, 28 first-time pregnancies needed to be screened and treated to prevent one NICU admission, according to Sera Prognostics. Interventions were well tolerated, and the approach may support healthcare cost savings.
Positive
- 22% relative reduction in NICU admissions in first-time pregnancies
- Two-fold reduction in NICU admissions after spontaneous preterm birth
- 30% relative reduction in severe composite neonatal morbidity (6.4% vs. 9.1%)
- 28 first-time pregnancies screened and treated to prevent one NICU admission
- Interventions (progesterone, low-dose aspirin, care management) reported as well tolerated
Negative
- None.
Market reaction after PRIME subgroup clinical data: SERA -4.37% in the Jul 10 session
In the Jul 10 session, SERA declined 4.37%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 30 | Board appointment | Positive | +11.5% | Veteran diagnostics executive Mark Capone added to board and compensation committee. |
| Jun 24 | ARPA-H collaboration | Positive | +0.0% | Joined up to $10.4M ARPA-H program to develop point-of-care fetal hypoxia test. |
| Jun 23 | Medicaid coverage push | Positive | -2.2% | Illinois initiative to expand Medicaid coverage for proteomic preterm birth testing. |
| Jun 01 | Board transition | Neutral | -6.8% | Director Jeff Elliott to step down, with search underway for replacement candidate. |
| May 06 | 1Q26 earnings | Positive | +6.1% | Reported PRIME trial benefits, small revenue, sizeable cash, and runway through 2029. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news with clear strategic or clinical milestones has often seen positive price reactions, while policy- or collaboration-focused items have produced flat or negative moves.
Key Terms
randomized controlled trial medical
neonatal intensive care unit medical
biomarker medical
morbidity medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- Study Highlights Screening Efficiency and Potential Cost Savings in a Large Underserved Population --
Because NICU care is among the most expensive types of hospital care, reducing admissions has the potential to generate meaningful healthcare savings while improving newborn health outcomes. Four in ten
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 a30% 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.
"This study demonstrates the power of tailoring pregnancy care for first-time pregnancies," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "These results show that the PreTRM Test-guided care pathway can improve outcomes in this large subgroup within a pregnant population where the least information is available to evaluate risk. Delivering on the potential to improve affordability, an important result for patients, providers, and payers."
"First-time pregnancies have been a significant contributor to spontaneous preterm birth and long presented a challenge for clinicians because of the lack of prior obstetric history to guide risk assessment," said Anthony C. Sciscione, DO, lead author of the study. "These findings show that biomarker-guided care can identify risk earlier and enable interventions that meaningfully improve neonatal outcomes, including reducing NICU admissions in this large and often underserved population."
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.
About Sera Prognostics, Inc.
Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year,
About the PreTRM® Test
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.
Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to broader adoption of effective care strategies across diverse clinical settings; reducing healthcare costs; and the Company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Investor Contact
Jennifer Zibuda, Head of Investor Relations
jzibuda@sera.com
+1 (801) 396-8043
Media Contact
Nicole Kaplan at Allison Worldwide
sera@allisonworldwide.com
+1 (847) 721-6033
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SOURCE Sera Prognostics, Inc.