SAN CARLOS, Calif. — February 6, 2026 — Leads & Copy —
Natera, Inc. (NASDAQ: NTRA) has launched EDEN, a large, multi-center prospective study to evaluate its non-invasive prenatal screening test for early risk assessment of preeclampsia and other serious pregnancy complications.
Preeclampsia affects approximately 5-8% of pregnancies and remains a leading cause of maternal and neonatal morbidity. Clinical guidelines recommend low-dose aspirin for patients with established risk factors for preeclampsia. However, current risk assessment relies primarily on clinical characteristics and does not provide individualized estimates of risk or response to preventive strategies. Adverse pregnancy outcomes affect an estimated 20% of pregnancies in the United States and are associated with substantial maternal and fetal morbidity and mortality.
EDEN 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.
Natera’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.
Sheetal Parmar, senior vice president of medical affairs at Natera, said that for more than a decade, Natera has advanced pregnancy care through highly sensitive, non-invasive testing. With EDEN, they 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 care.
Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado.
Source: Natera
