Landmark Study Finds PreTRM® Blood Test Reduces Earliest Preterm Births and Newborn Complications

Rhea-AI Summary

Sera Prognostics (NASDAQ: SERA) reported PRIME, a randomized trial of 5,018 women published Jan 7, 2026 in PREGNANCY, showing the PreTRM blood test plus targeted interventions reduced earliest preterm births and newborn complications.

Key results: 56% fewer births before 32 weeks, 32% fewer before 35 weeks, 20% fewer NICU admissions, and a 20% reduction in odds of neonatal morbidity. The study found one NICU day saved per 4.2 patients screened and a number-needed-to-screen of 39 to prevent one NICU admission.

Positive

• 56% fewer births before 32 weeks
• 32% fewer births before 35 weeks
• 20% fewer NICU admissions
• One NICU day saved per 4.2 patients screened
• Number-needed-to-screen 39 to prevent one NICU admission

Negative

• PRIME excluded patients with prior spontaneous preterm birth, limiting applicability to high‑risk groups
• Intervention was a bundled therapy (progesterone, low‑dose aspirin, care management) so individual component effects are not isolated

News Market Reaction

+11.49%

13 alerts

+11.49% News Effect

+18.0% Peak in 24 hr 7 min

+$15M Valuation Impact

$149M Market Cap

0.6x Rel. Volume

On the day this news was published, SERA gained 11.49%, reflecting a significant positive market reaction. Argus tracked a peak move of +18.0% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $15M to the company's valuation, bringing the market cap to $149M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Trial size: 5,018 women Early preterm reduction: 56% fewer babies <32 weeks Preterm <35 weeks: 32% fewer babies <35 weeks +5 more

8 metrics

Trial size 5,018 women PRIME randomized controlled trial population

Early preterm reduction 56% fewer babies <32 weeks Outcomes with PreTRM-guided care vs standard care

Preterm <35 weeks 32% fewer babies <35 weeks Outcomes with PreTRM-guided care vs standard care

NICU admissions 20% fewer babies admitted NICU admission reduction in PRIME Study

Neonatal morbidity 20% reduction in odds Fewer health complications for newborns

NICU day saved 1 day per 4.2 patients NICU length-of-stay reduction with screening

Number needed to screen 39 vs 150 Patients to screen to prevent one NICU admission (PreTRM vs standard)

US preterm rate 1 in 10 infants Preterm birth impact cited by company

Market Reality Check

Price: $3.66 Vol: Volume 34,137 is light at...

low vol

$3.66 Last Close

Volume Volume 34,137 is light at 0.53x the 20-day average of 63,813 ahead of this publication. low

Technical Shares at $2.96 were trading slightly above the 200-day MA of $2.89, but still 66.09% below the 52-week high.

Peers on Argus

Peers in medical diagnostics showed mixed moves, with names like ICAD (+3.48%) a...

Peers in medical diagnostics showed mixed moves, with names like ICAD (+3.48%) and RPID (+10.82%) up while OWLT fell 5.63%. Sector action did not clearly track SERA’s pre-news weakness.

Historical Context

5 past events · Latest: Nov 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 24	PRIME publication news	Positive	+4.6%	PRIME study acceptance by a peer‑reviewed journal and upcoming data sharing.
Nov 13	Quarterly earnings	Neutral	+0.3%	Q3 2025 financials showing small revenue, losses, and strong cash runway.
Oct 30	Earnings call notice	Neutral	-2.1%	Announcement of upcoming Q3 results call and webcast logistics.
Oct 01	Executive appointment	Positive	-3.6%	Appointment of a new Chief Medical Officer to lead clinical strategy.
Aug 28	Investor conference	Positive	+8.4%	Planned presentation at a major investment conference to highlight strategy.

Pattern Detected

Recent news has generally seen modestly positive or mixed reactions, with occasional selloffs on otherwise constructive corporate updates.

Recent Company History

Over the past six months, Sera has focused on building the clinical and commercial foundation for the PreTRM Test. On Nov. 24, 2025, PRIME study acceptance for publication led to a 4.64% gain. Q3 2025 results on Nov. 13 highlighted early revenue ($16,000) but substantial investment and cash of $102.4M, with a muted price move. Management strengthened its clinical bench with a new CMO on Oct. 1, while multiple conference and investor events aimed to raise visibility. Today’s full PRIME publication builds directly on that trajectory of evidence generation.

Market Pulse Summary

The stock surged +11.5% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +11.5% in the session following this news. A strong positive reaction aligns with the PRIME study’s robust clinical data, including 56% fewer births before 32 weeks and 20% fewer NICU admissions. Past PRIME-related news on Nov. 24, 2025 also saw a favorable move. However, SERA traded 66.09% below its 52-week high pre-publication, and insider activity in late 2025 showed net selling, factors that could influence how durable any rally becomes.

Key Terms

randomized controlled trial, neonatal morbidity, nicu, vaginal progesterone

4 terms

randomized controlled trial medical

"A randomized controlled trial of 5,018 women has found that a simple blood test"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

neonatal morbidity medical

"Fewer health complications for newborns (20% reduction in odds of neonatal morbidity)"

Neonatal morbidity means health problems or complications that affect newborn babies during the first few weeks of life, ranging from temporary conditions like breathing or feeding difficulties to longer-term issues that require ongoing care. Investors should care because higher rates can drive demand for medical products and services, raise treatment costs, trigger regulatory scrutiny or liability, and serve like an early warning light about public-health trends that affect company revenue and risk.

nicu medical

"20% fewer babies admitted to the NICU"

A NICU (neonatal intensive care unit) is a specialized hospital unit that provides around-the-clock medical care for newborns who are premature, ill, or need close monitoring. For investors, NICU capacity and outcomes signal demand for neonatal medical equipment, staffing, and services, and can affect hospital revenues, insurance costs, and the market for related products—think of it as the intensive-care wing that determines how well a hospital serves its smallest, most vulnerable patients.

vaginal progesterone medical

"higher risk for preterm birth received daily vaginal progesterone, low-dose aspirin"

Vaginal progesterone is a form of the natural hormone progesterone delivered directly inside the vagina to support early pregnancy and reduce the risk of preterm birth, and to help fertility treatments like IVF. Investors care because sales, clinical trial results, regulatory approvals, and insurance coverage for this targeted, lower‑systemic treatment can drive revenue, affect competing products, and influence the valuation of companies in women’s health and reproductive medicine — think of it as a focused fertilizer applied at the root to help a fragile plant grow.

AI-generated analysis. Not financial advice.

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.

"The PreTRM Test represents a meaningful step forward in how we identify and manage risk for preterm birth," said Dr. Brian Iriye, principal investigator for the PRIME study. "Today, many women who ultimately deliver prematurely would be considered 'low risk' by traditional criteria, and that gap is not acceptable. By quantifying a woman's biologic risk early in pregnancy, the PreTRM Test allows us to move beyond guesswork and implement a straightforward, low-burden, evidence-based care plan that supports her, protects her baby, and improves outcomes for the families we serve—while reducing the downstream cost and complications of being born too soon."

"These findings not only reinforce the strong results from the AVERT PRETERM Trial but also enhance our ability to build a robust, differentiated body of clinical evidence for the PreTRM test-and-treat strategy," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "With preterm birth still impacting 1 in 10 infants in the U.S., our commitment extends beyond innovative technologies like the PreTRM Test to driving education, awareness, and equitable access to prenatal care. Looking ahead, we see a significant opportunity to transform maternal and neonatal health outcomes, setting a new commercial and clinical standard that delivers measurable value for patients, providers, and health systems."

Dr. Brian Iriye, principal investigator for the PRIME study, Zhenya Lindgardt, President and CEO of Sera and Dr. Tiffany Inglis, Chief Medical Officer of Sera, will be participating in a Jefferies fireside chat to discuss the full results of the PRIME study. The call will take place on Friday, January 9, 2026, at 8:30 a.m. Eastern Time. Interested parties may reach out to their Jefferies sales representative for details.

The PreTRM Test and targeted interventions demonstrated a more effective and efficient strategy in reducing NICU admissions and length of stay than current standard care. When using the PreTRM Test and targeted interventions, the number needed to screen to prevent a single NICU admission was approximately 39 – as compared to 150 when using current standard care. Further, only about 4 women need to be screened with PreTRM and treated to prevent one day in the NICU. As PRIME excluded women with prior spontaneous preterm birth or premature cervical shortening at the time of enrollment, the study results illustrate the value of the test for patients at otherwise low overall risk of preterm birth and therefore not identified by current screening approaches.

The PRIME study included a diverse population with no significant differences in patient demographics in the control vs treatment arm. With birth complications and preterm birth disproportionately impacting certain populations, the PreTRM Test and targeted interventions offer a solution to improve outcomes for historically disadvantaged groups.

About Preterm Birth
Preterm birth—any birth before 37 weeks' gestation—is the leading cause of illness and death in newborns. In the United States, more than one in ten infants is born prematurely each year, with significant long-term health and economic consequences.

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.

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.

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 building a robust, differentiated body of clinical evidence for the PreTRM® test-and-treat strategy; driving education, awareness, and equitable access to prenatal care; transforming maternal and neonatal health outcomes; setting a new commercial and clinical standard that delivers measurable value for patients, providers, and health systems; the Company's participation in a Jefferies fireside chat to discuss the full results of the PRIME study; 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; the COVID-19 pandemic and its potential lingering impact on our operations, as well as the business or operations of third parties with whom we conduct business; 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.

Contacts:
Investor Contact
Jennifer Zibuda, Head of Investor Relations
jzibuda@sera.com
+1 (801) 396-8043
Media Contact
Bridget Mahoney at Allison Worldwide
sera@allisonworldwide.com
+1 (716) 868-7505

View original content to download multimedia:https://www.prnewswire.com/news-releases/landmark-study-finds-pretrm-blood-test-reduces-earliest-preterm-births-and-newborn-complications-302655198.html

SOURCE Sera Prognostics, Inc.

FAQ

What did SERA announce about the PRIME study published Jan 7, 2026?

PRIME (5,018 women) showed the PreTRM test plus targeted interventions cut births <32 weeks by 56% and reduced NICU admissions by 20%.

How does the PreTRM test impact NICU use according to the PRIME study?

The study reported a 20% reduction in NICU admissions, one NICU day saved per 4.2 patients screened, and a number-needed-to-screen of 39 to prevent one NICU admission.

What treatments did higher‑risk women receive in the SERA PRIME trial?

Women identified as higher risk received daily vaginal progesterone, low‑dose aspirin, and nurse‑led care management.

Will the PRIME results change SERA's commercial outlook for PreTRM (SERA)?

SERA framed the PRIME results as strengthening clinical evidence and commercial opportunity, highlighting potential to set a new clinical standard for early risk screening.

Are PRIME results generalizable to women with prior preterm birth?

PRIME excluded women with prior spontaneous preterm birth or premature cervical shortening, so findings apply to women without those prior high‑risk conditions.