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Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes
Large prospective study to evaluate a non-invasive prenatal screening test AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in
About this update from Natera, Inc.
[{"type":"text","content":"\nLarge prospective study to evaluate a non-invasive prenatal screening test\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the launch of EDEN, a large, multi-center prospective study designed to evaluate the company’s non-invasive prenatal screening test for early risk assessment of preeclampsia and other serious pregnancy complications.\n\n\nPreeclampsia affects approximately 5-8% of pregnancies and remains a leading cause of maternal and neonatal morbidity.1 While clinical guidelines recommend low-dose aspirin for patients with established risk factors for preeclampsia2, current risk assessment relies primarily on clinical characteristics and does not provide individualized estimates of risk or response to preventive strategies.3 More broadly, adverse pregnancy outcomes affect an estimated 20% of pregnancies in the United States and are associated with substantial maternal and fetal morbidity and mortality.4\n\n\nEDEN is designed as a definitive prospective study of Natera’s integrated prenatal risk assessment test, which combines cell-free DNA (cfDNA), additional analytes and clinical data. The study plans to enroll up to 7,500 pregnant participants in the United States between 9 and 15 weeks’ gestation to evaluate risk for preeclampsia, including earlier-onset and more severe disease, along with additional adverse pregnancy outcomes.\n\n\nNatera’s new test builds on previously published research demonstrating associations between cfDNA characteristics and adverse pregnancy outcomes. These studies showed that cfDNA-derived markers, when combined with patient characteristics, can identify risk for preeclampsia with performance comparable to approaches that rely on specialized imaging or additional biomarkers, and that nonreportable cfDNA results are associated with increased risk of pregnancy complications.5,6\n\n\n“For more than a decade, Natera has advanced pregnancy care through highly sensitive, non-invasive testing,” said Sheetal Parmar, senior vice president of medical affairs at Natera. “With EDEN, we are evaluating a next-generation test designed to identify pregnancies at increased risk for preeclampsia and other serious complications earlier and with greater precision, using data that are already part of routine prenatal c...