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SERA PROGNOSTICS ANNOUNCES PRIMARY ENDPOINT CRITERIA MET IN PIVOTAL PRIME STUDY INTERIM LOOK - ENROLLMENT TO STOP DUE TO SUCCESS
SALT LAKE CITY, Dec. 6, 2023 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health
About this update from Sera Prognostics, Inc.
[{"type":"text","content":"SALT LAKE CITY, Dec. 6, 2023 /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 that the Data Safety Monitoring Board (DSMB) overseeing its 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. The Company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.\n\n \n \n \n \n \n \n\n \n\"We are excited by this report of efficacy from the DSMB,\" said Zhenya Lindgardt, President and CEO of Sera Prognostics. \"It is unexpected for trials to stop early for efficacy since most statistical power is typically reserved for the final analysis, which makes this event that much more encouraging. We look forward to sharing top-line results once we have had a chance to analyze the interim look data. We believe this will add to the PREVENT and AVERT studies in the growing, consistent body of evidence for our PreTRM® test that advances our mission to save lives and improve health for mothers and babies across the globe.\"\nAbout Sera Prognostics, Inc.\nSera 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, Utah.\nAbout Preterm Birth\nPreterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2022 March of Dimes Report Card...