Sera Prognostics to Present PRIME Study Results at 2025 SMFM Pregnancy Meeting
Sera Prognostics (NASDAQ: SERA) announced that its PRIME study results will be presented at the Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™ on January 31, 2025. Dr. Brian Iriye, principal investigator, will deliver the presentation focusing on how the PreTRM test, which identifies women at higher risk of preterm delivery, combined with targeted clinical interventions affects neonatal outcomes.
The study's enrollment was stopped in December 2023 after achieving at least one primary endpoint with statistical significance. The PRIME abstract was selected as one of five late-breaking presentations and is expected to be published in mid-January 2025. The annual Pregnancy Meeting™ is considered the world's leading conference on pregnancy, featuring various educational and scientific programs.
Sera Prognostics (NASDAQ: SERA) ha annunciato che i risultati del suo studio PRIME saranno presentati alla Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™ il 31 gennaio 2025. Il Dr. Brian Iriye, ricercatore principale, presenterà come il test PreTRM, che identifica le donne a maggior rischio di parto prematuro, combinato con interventi clinici mirati, influisce sui risultati neonatali.
L'arruolamento dello studio è stato interrotto a dicembre 2023 dopo aver raggiunto almeno un endpoint primario con significatività statistica. L'abstract del PRIME è stato selezionato come una delle cinque presentazioni a risultati recenti ed è previsto che venga pubblicato a metà gennaio 2025. L'annuale Pregnancy Meeting™ è considerata la conferenza di riferimento mondiale sulla gravidanza, con vari programmi educativi e scientifici.
Sera Prognostics (NASDAQ: SERA) anunció que los resultados de su estudio PRIME se presentarán en la Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™ el 31 de enero de 2025. El Dr. Brian Iriye, investigador principal, realizará la presentación centrada en cómo la prueba PreTRM, que identifica a las mujeres con mayor riesgo de parto prematuro, combinada con intervenciones clínicas específicas, afecta los resultados neonatales.
La inscripción en el estudio se detuvo en diciembre de 2023 después de alcanzar al menos un objetivo primario con significación estadística. El resumen del PRIME fue seleccionado como una de las cinco presentaciones de última hora y se espera que se publique a mediados de enero de 2025. La Pregnancy Meeting™ anual se considera la conferencia líder en el mundo sobre embarazo, con diversos programas educativos y científicos.
Sera Prognostics (NASDAQ: SERA)는 PRIME 연구 결과가 2025년 1월 31일에 열리는 Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™에서 발표될 것이라고 발표했습니다. 주 연구자인 Brian Iriye 박사는 PreTRM 테스트가 조산 위험이 높은 여성들을 식별하고, 타겟 임상 개입과 결합하여 신생아 결과에 미치는 영향에 대해 발표할 예정입니다.
연구의 등록은 2023년 12월에 통계적 유의성을 가진 주요 목표를 최소한 하나 달성한 후 중단되었습니다. PRIME 초록은 다섯 개의 최신 발표 중 하나로 선정되었으며, 2025년 1월 중반에 발표될 예정입니다. 매년 열리는 Pregnancy Meeting™은 세계에서 가장 저명한 임신 관련 회의로 다양한 교육 및 과학 프로그램이 진행됩니다.
Sera Prognostics (NASDAQ: SERA) a annoncé que les résultats de son étude PRIME seront présentés lors de la Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™ le 31 janvier 2025. Le Dr. Brian Iriye, chercheur principal, donnera la présentation axée sur la manière dont le test PreTRM, qui identifie les femmes à risque plus élevé d'accouchement prématuré, combiné à des interventions cliniques ciblées, affecte les résultats néonatals.
Le recrutement de l'étude a été arrêté en décembre 2023 après avoir atteint au moins un critère principal avec une signification statistique. L'abstract du PRIME a été sélectionné comme l'une des cinq présentations de dernière minute et devrait être publié à la mi-janvier 2025. La réunion annuelle Pregnancy Meeting™ est considérée comme la conférence leader mondiale sur la grossesse, présentant divers programmes éducatifs et scientifiques.
Sera Prognostics (NASDAQ: SERA) gab bekannt, dass die Ergebnisse der PRIME-Studie am 31. Januar 2025 auf dem Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting™ präsentiert werden. Dr. Brian Iriye, der Hauptforscher, wird die Präsentation halten und sich darauf konzentrieren, wie der PreTRM-Test, der Frauen mit höherem Risiko für eine Frühgeburt identifiziert, in Kombination mit gezielten klinischen Interventionen die Ergebnisse für Neugeborene beeinflusst.
Die Rekrutierung für die Studie wurde im Dezember 2023 gestoppt, nachdem ein primäres Endziel mit statistischer Signifikanz erreicht wurde. Das PRIME-Abstract wurde als eine von fünf späten Präsentationen ausgewählt und wird voraussichtlich Mitte Januar 2025 veröffentlicht. Das jährliche Pregnancy Meeting™ gilt als die weltweit führende Konferenz zur Schwangerschaft mit verschiedenen Bildungs- und wissenschaftlichen Programmen.
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The study – Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) – evaluated how pairing the PreTRM test, used to identify pregnant women who are at higher risk of delivering preterm, with targeted clinical interventions may affect neonatal outcomes. The Company announced in December 2023 that it had stopped enrollment for the PRIME study following notice from the Data Safety Monitoring Board that the pre-planned interim analysis achieved at least one of its primary endpoints at the required level of statistical significance. Since then, the Company has focused on data gathering and analysis for the complete cohort enrolled before the December 2023 stoppage, ultimately submitting a late-breaking abstract last month for SMFM's consideration.
"Sera is honored that data for its PreTRM® test will be presented from the podium at SMFM," said Zhenya Lindgardt, President & CEO of Sera Prognostics. "This is a prestigious conference, and exactly the right platform from which to share these results with the community."
The annual Pregnancy Meeting™ is the centerpiece of the Society for Maternal-Fetal Medicine's work and widely considered the world's leading conference on the subject of pregnancy, featuring postgraduate courses and workshops, luncheon roundtables, scientific forums, oral and poster presentations, industry learning, exhibits, and more. The PRIME abstract, one of five selected for presentation in late-breaking oral sessions, is expected to be published by SMFM ahead of the meeting in mid-January 2025.
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 Salt Lake City,
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
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 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 Dr. Brian Iriye presenting the results of the PRIME study at the podium at the Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting on January 31, 2025 at 10:15 a.m. MT; the SMFM Pregnancy Meeting being exactly the right platform from which to share PRIME results with the community; publication of the PRIME abstract by SMFM ahead of the meeting in mid-January 2025; 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.
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SOURCE Sera Prognostics, Inc.
FAQ
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