Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes

AUSTIN, Texas--(BUSINESS WIRE)--Natera, 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.

Preeclampsia affects approximately 5-8% of pregnancies and remains a leading cause of maternal and neonatal morbidity.1While 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.3More 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

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.5,6

“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 care.”

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. 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. For more information, visitwww.natera.com.

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available atwww.natera.com/investorsandwww.sec.gov.