SALT LAKE CITY, March 18, 2022 — 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 presented data demonstrating the effective prediction of preeclampsia using protein biomarkers and clinical factors.
The presentation titled “Comparison of Protein Biomarkers to Clinical Factors for Preeclampsia in Two Cohorts” was given by lead author Julja Burchard et al this morning at the 69th Annual Meeting of the Society for Reproductive Investigation (SRI) in Denver, Colorado, during Late Breaking Session LB-002 from 9:00-10:30 AM.
This study was a secondary analysis of two large independent pregnancy cohorts totaling more than 10,500 enrolled patients, PAPR (NCT01371019; 11 U.S. sites, 2011-2013) and TREETOP (NCT02787213; 18 U.S. sites, 2016-2018) investigating the ability of 6 clinical factors and 31 protein biomarkers to predict either preeclampsia at any gestational age or preterm preeclampsia occurring before 37 weeks of pregnancy in women prior to receiving a clinical diagnosis of preeclampsia.
Of the 6 clinical factors, only having had preeclampsia in a prior pregnancy was significantly predictive of both outcomes in both studies. Of 31 biomarkers, significant prediction of preeclampsia and preterm preeclampsia was shown by 7 and 5 biomarkers, respectively, in both studies. Biomarkers, paired with the clinical predictor preeclampsia in a previous pregnancy, showed additive predictive performance and contributed more strongly for prediction of preterm preeclampsia. Biomarkers alone, whether or not clinical factors are available, also showed independent predictive performance of preeclampsia, enabling more timely interventions designed to address a patient’s individual risk.
“We are pleased to have this important study completed on preeclampsia, a major cause of prematurity and neonatal and maternal health complications,” said Gregory C. Critchfield, MD, MS, Chairman and Chief Executive Officer of Sera Prognostics. “This study, conducted by leading researchers in maternal-fetal medicine, demonstrates progress on our pipeline and our ongoing commitment to providing valuable information to doctors and pregnant women in Sera Prognostics’ journey as The Pregnancy Company.”
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 deliver early, pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, 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 located 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 2021 March of Dimes Report Card shows that more than one in ten infants is born prematurely. 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 health care 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 19th or 20th week of pregnancy, which women are at increased risk for preterm birth, 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.
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