Sera Prognostics Set to Reveal PRIME Study Insights at 2025 SMFM Event
Sera Prognostics, Inc., celebrated as The Pregnancy Company®, is preparing to unveil the results of its groundbreaking PRIME study at the prestigious Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting. Scheduled for January 31, 2025, at 10:15 a.m. MT, this significant presentation will be delivered by Dr. Brian Iriye, a distinguished expert in maternal-fetal medicine, at the High Risk Pregnancy Center in Las Vegas, Nevada.
The PRIME study, formally titled Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes, serves as a critical examination of the efficacy of the PreTRM test in identifying pregnant women at heightened risk for preterm delivery. Ultimately, this research seeks to understand how complementing the PreTRM test with precise clinical interventions can enhance neonatal health outcomes.
In December 2023, Sera Prognostics made a substantial announcement regarding the halt of further enrollment for the PRIME study after receiving encouraging feedback from the Data Safety Monitoring Board. This board noted that the interim analysis had successfully reached one of its primary endpoints with the necessary statistical significance, paving the way for deeper data analysis and interpretation of the cohort that was already enrolled prior to this decision.
"We are proud that our PreTRM® test data will grace the podium at the SMFM meeting," stated Zhenya Lindgardt, President and CEO of Sera Prognostics. "This event is not only a key meeting for us but also a vital platform for sharing insightful results with a global audience engaged in pregnancy medicine."
The annual Pregnancy Meeting is a cornerstone event organized by the SMFM, recognized worldwide as the leading conference dedicated to issues surrounding pregnancy. It features an array of educational opportunities, including postgraduate courses, workshops, roundtable discussions, and the latest in scientific research and developments. The PRIME study abstract is among only five that have been selected for presentation in late-breaking oral sessions, highlighting its significance and potential impact on the field of maternal-fetal medicine. Attendees can look forward to the publication of the PRIME abstract by SMFM prior to the meeting in mid-January 2025.
Sera Prognostics remains committed to enhancing maternal and neonatal health through precise and innovative diagnostic solutions. The company’s core mission is to furnish healthcare providers and expectant mothers with pivotal information, facilitating proactive healthcare decisions that lead to better birth outcomes. The PreTRM® Test—uniquely positioned as the only commercially available blood-based test—plays a central role in this mission. By analyzing specific biomarkers in the blood, this test provides critical insights into individual risks of spontaneous preterm birth, thereby empowering clinicians to take necessary precautions.
Preterm birth, defined as any birth occurring before the 37-week mark of gestation, poses considerable health risks for both infants and mothers. A significant percentage of U.S. infants, over one in ten, are born prematurely, leading to long-term health complications ranging from learning disabilities to chronic respiratory disorders. The economic implications are equally staggering, with healthcare costs tied to managing both immediate and subsequent challenges of prematurity amounting to approximately $25 billion for 2016 alone.
The PreTRM® Test allows physicians to make informed decisions during critical periods of gestation, specifically from weeks 18 to 20. By pinpointing those at elevated risk for preterm outcomes, healthcare providers are enabled to offer tailored interventions, potentially transforming the landscape of prenatal care.
In light of the escalating challenges tied to prematurity and the significant burden it imposes on families and healthcare systems alike, Sera Prognostics’ groundbreaking work in this field is poised to make impactful strides toward improving global maternal and neonatal health standards. Through initiatives like the PRIME study and the PreTRM Test, Sera continues to forge ahead in fulfilling its mission to advance health outcomes for mothers and their newborns.
Sera Prognostics is based in Salt Lake City, Utah, and its efforts underscore a robust commitment to tackling one of the most critical issues in modern healthcare.
The PRIME study, formally titled Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes, serves as a critical examination of the efficacy of the PreTRM test in identifying pregnant women at heightened risk for preterm delivery. Ultimately, this research seeks to understand how complementing the PreTRM test with precise clinical interventions can enhance neonatal health outcomes.
In December 2023, Sera Prognostics made a substantial announcement regarding the halt of further enrollment for the PRIME study after receiving encouraging feedback from the Data Safety Monitoring Board. This board noted that the interim analysis had successfully reached one of its primary endpoints with the necessary statistical significance, paving the way for deeper data analysis and interpretation of the cohort that was already enrolled prior to this decision.
"We are proud that our PreTRM® test data will grace the podium at the SMFM meeting," stated Zhenya Lindgardt, President and CEO of Sera Prognostics. "This event is not only a key meeting for us but also a vital platform for sharing insightful results with a global audience engaged in pregnancy medicine."
The annual Pregnancy Meeting is a cornerstone event organized by the SMFM, recognized worldwide as the leading conference dedicated to issues surrounding pregnancy. It features an array of educational opportunities, including postgraduate courses, workshops, roundtable discussions, and the latest in scientific research and developments. The PRIME study abstract is among only five that have been selected for presentation in late-breaking oral sessions, highlighting its significance and potential impact on the field of maternal-fetal medicine. Attendees can look forward to the publication of the PRIME abstract by SMFM prior to the meeting in mid-January 2025.
Sera Prognostics remains committed to enhancing maternal and neonatal health through precise and innovative diagnostic solutions. The company’s core mission is to furnish healthcare providers and expectant mothers with pivotal information, facilitating proactive healthcare decisions that lead to better birth outcomes. The PreTRM® Test—uniquely positioned as the only commercially available blood-based test—plays a central role in this mission. By analyzing specific biomarkers in the blood, this test provides critical insights into individual risks of spontaneous preterm birth, thereby empowering clinicians to take necessary precautions.
Preterm birth, defined as any birth occurring before the 37-week mark of gestation, poses considerable health risks for both infants and mothers. A significant percentage of U.S. infants, over one in ten, are born prematurely, leading to long-term health complications ranging from learning disabilities to chronic respiratory disorders. The economic implications are equally staggering, with healthcare costs tied to managing both immediate and subsequent challenges of prematurity amounting to approximately $25 billion for 2016 alone.
The PreTRM® Test allows physicians to make informed decisions during critical periods of gestation, specifically from weeks 18 to 20. By pinpointing those at elevated risk for preterm outcomes, healthcare providers are enabled to offer tailored interventions, potentially transforming the landscape of prenatal care.
In light of the escalating challenges tied to prematurity and the significant burden it imposes on families and healthcare systems alike, Sera Prognostics’ groundbreaking work in this field is poised to make impactful strides toward improving global maternal and neonatal health standards. Through initiatives like the PRIME study and the PreTRM Test, Sera continues to forge ahead in fulfilling its mission to advance health outcomes for mothers and their newborns.
Sera Prognostics is based in Salt Lake City, Utah, and its efforts underscore a robust commitment to tackling one of the most critical issues in modern healthcare.
Topics Health）
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