Sera Prognostics PreTRM® Test Prevention Strategy Demonstrates 18% Reduction in Severe Neonatal Morbidity and Mortality in Newly Published AVERT Trial

Rhea-AI Summary

Sera Prognostics has announced that their PreTRM® test-and-treat strategy has demonstrated significant improvements in neonatal health outcomes, as reported in the international journal Diagnostics. The AVERT PRETERM TRIAL showed an 18% reduction in severe neonatal morbidity and mortality, a 7-day reduction in the average hospital stay for neonates, a 2.48-week increase in gestational age for births before 32 weeks, and a 28-day reduction in hospital stays for neonates born before 32 weeks. These findings are significant for improving neonatal health in pregnancies previously considered low-risk. Additionally, the Data Safety and Monitoring Board has recommended stopping enrollment in the PRIME study due to meeting efficacy endpoints. Final results from this study are currently being analyzed.

Positive

• 18% reduction in severe neonatal morbidity and mortality.
• 7-day reduction in mean neonatal hospital length of stay.
• 2.48-week increase in average gestational age for births before 32 weeks.
• 28-day reduction in hospital stay for neonates born before 32 weeks.
• Statistically significant improvements in neonatal health outcomes reported.

Negative

• None.

Insights

Medical Research Analyst

Sera Prognostics Inc.’s AVERT PRETERM TRIAL has published notable results indicating significant improvements in neonatal health outcomes. The test-and-treat strategy using the PreTRM® test shows an 18% reduction in severe neonatal morbidity and mortality and a reduction of 7 days in the average hospital stay for newborns. These are substantial figures given that preterm births are a major challenge in neonatal care, often leading to long-term health complications.

From a medical research perspective, the results imply that early identification of risk through biomarkers can indeed lead to better management and prevention strategies. Implementing a targeted intervention based on the PreTRM® test could be a game-changer in prenatal care, potentially setting a new standard. The data also supports the notion that even pregnancies deemed low-risk can benefit from such advanced testing, which could shift prevailing practices towards more comprehensive screening protocols.

Overall, these findings add a new layer of evidence supporting the broader adoption of biomarker-based screenings in obstetrics, potentially reducing healthcare costs associated with prolonged neonatal care.

Rating: Positive

Financial Analyst

From a financial perspective, the results of the AVERT PRETERM TRIAL are encouraging for Sera Prognostics Inc. The 18% reduction in severe neonatal morbidity and mortality translates into potential savings on healthcare costs, thus making the PreTRM® test a compelling product in the market. This positive data could lead to increased adoption rates among healthcare providers, driving revenue growth for the company in the near and long term.

Furthermore, the publication in a peer-reviewed journal like Diagnostics adds credibility and could accelerate acceptance within the medical community. Investors should note that while the company is currently focusing on analyzing the final PRIME study results, the interim results already indicate that the product meets the efficacy criteria, which is a promising sign.

However, investors should also be mindful of the potential costs associated with scaling up production and marketing efforts required to capitalize on these positive results. Monitoring the company’s spending in these areas will be important to understanding the financial health and long-term viability of Sera Prognostics.

Rating: Positive

Market Research Analyst

The AVERT PRETERM TRIAL results can have a notable impact on the market for prenatal care. With an 18% reduction in severe neonatal morbidity and mortality and other significant improvements, the PreTRM® test positions itself as a vital tool for healthcare providers. This could lead to a broader market adoption, especially among practices that manage high volumes of expectant mothers.

Additionally, the reduction in hospital stays and neonatal intensive care unit (NICU) time not only benefits patients but also alleviates some of the financial burden on healthcare systems. This dual advantage could make the product attractive not only to healthcare providers but also to insurance companies, which could result in more favorable reimbursement policies and higher utilization rates.

Given the competitive landscape in prenatal care, Sera Prognostics seems to have carved out a significant niche with these promising results. However, the company needs to ensure it maintains its competitive edge through continuous innovation and effective marketing to sustain and grow its market share.

Rating: Positive

Sera Prognostics Announces Publication of Positive AVERT PRETERM TRIAL Results in the International Peer-Reviewed Journal, Diagnostics

SALT LAKE CITY, July 9, 2024 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company^® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the publication in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis, of the top-line results from the AVERT PRETERM TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls), conducted at ChristianaCare in Wilmington, Delaware.

PreTRM^® test-and-treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length-of-stay

Previously, Sera reported that both co-primary outcomes—reduction of severe neonatal morbidity or neonatal death; and decreased length of neonatal hospital stay—met their endpoints, and the improvements in outcome with a PreTRM^® test-and-treat approach were statistically significant. Notably, results from the AVERT PRETERM TRIAL indicated:

• An 18% reduction in severe neonatal morbidity and mortality,
• A 7-day reduction in mean neonatal hospital length of stay,
• Increased average gestational age at birth before 32 weeks of 2.48 weeks,
• And a 28-day reduction in neonatal length of hospital stay for babies born before 32 weeks' gestation, reducing time spent in the hospital for those at risk of earliest delivery.

The manuscript also reports that neonatal morbidity and mortality and hospital and NICU length of stay were significantly reduced in the entire intent-to-treat population. The test and treat strategy was associated with a decreased odds of preterm birth and spontaneous preterm birth at various gestational ages at birth and an average NICU length of stay savings of 0.6 days per pregnancy across all pregnancies tested.

"These results suggest that biomarker spontaneous preterm birth risk stratification and preventive interventions can ameliorate preterm birth complications in singleton, often nulliparous, pregnancies historically deemed low risk," said Dr. Matthew Hoffman, Marie E. Pinizzotto, M.D., Endowed Chair, Department of Obstetrics & Gynecology, Director, Center for Women & Children's Health Research, ChristianaCare, the study's principal investigator.

"The AVERT PRETERM TRIAL results demonstrate for the first time that the health of babies can be improved in asymptomatic pregnant mothers without typical risk factors by the combination of biomarkers for spontaneous preterm birth risk and targeted interventions," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "We are delighted to have published these clinically significant results in Diagnostics. We are now actively engaged in analyzing our final PRIME study results to continue to enrich an already broad portfolio of evidence for our PreTRM^® test-and-treat strategy in improving maternal and neonatal care while reducing healthcare costs."

Update on Sera Prognostics PRIME Study

As Sera announced in December 2023, the Data Safety and Monitoring Board (DSMB) overseeing the Company's pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. Sera Prognostics noted in May 2024 that deliveries of PRIME study participants, the remaining 2,200 who were enrolled before enrollment stopped per DSMB recommendation, were complete and all mothers and babies within the study have left the hospital and data gathering for the final PRIME results has begun.

About the AVERT PRETERM TRIAL

The AVERT PRETERM TRIAL evaluated the health benefit afforded to babies when pregnancies are screened with the PreTRM^® Test and physicians intervened based on those results. An active arm of approximately 1,463 expectant mothers in the ChristianaCare in Delaware was tested in mid-pregnancy to stratify for increased risk of spontaneous preterm birth risk and those at higher risk were offered evidence-based interventions, which included care management, more intensive education, and medications. A historical control arm of approximately 10,000 patients was drawn from the immediate 2-year period before the trial enrollment began. Important neonatal outcomes that included total neonatal length of hospital stay and composite neonatal morbidity/mortality were analyzed in the active and historical control arms.

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 and digital tools 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 Salt Lake City, Utah.

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 2023 March of Dimes Report Card shows that, for the last five consecutive years, more than one in ten infants is born prematurely in the United States. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual healthcare costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.

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 the final PRIME study results enriching an already broad portfolio of evidence for our PreTRM^® test-and-treat strategy; additional milestones in advancing the Company's role to improve maternal and neonatal healthcare outcomes; 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 Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. 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.

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SOURCE Sera Prognostics, Inc.

FAQ

What are the key findings of the AVERT PRETERM TRIAL for Sera Prognostics?

The AVERT PRETERM TRIAL demonstrated an 18% reduction in severe neonatal morbidity and mortality, a 7-day reduction in neonatal hospital stays, a 2.48-week increase in gestational age for births before 32 weeks, and a 28-day reduction in hospital stays for neonates born before 32 weeks.

How does the PreTRM® test-and-treat strategy affect neonatal health outcomes?

The PreTRM® test-and-treat strategy significantly improves neonatal health outcomes, including reducing severe neonatal morbidity and mortality by 18%, reducing hospital stays by 7 days on average, and increasing gestational age for early births by 2.48 weeks.

What is the impact of the PreTRM® test on hospital stays for neonates born before 32 weeks?

The PreTRM® test-and-treat strategy resulted in a 28-day reduction in hospital stays for neonates born before 32 weeks.

What did the Data Safety and Monitoring Board recommend for the PRIME study involving Sera Prognostics?

The Data Safety and Monitoring Board recommended stopping enrollment for the PRIME study due to meeting the efficacy endpoints at the pre-planned interim analysis.

When will the final results of the PRIME study be available?

Final results of the PRIME study are currently being analyzed following the completion of data gathering as of May 2024.