April 8, 2025 - San Francisco, Calif. - Mirvie announced today the results from a breakthrough study published today in Nature Communications that reveal new advances in the biological understanding of hypertensive disorders of pregnancy (HDP), including preeclampsia - a leading cause of maternal morbidity and mortality as well as preterm birth. Researchers used data from more than 9,000 representative pregnancies within the multi-center Mirvie-sponsored Miracle of Life prospective study to discover and validate RNA signatures capable of distinguishing between severe and mild hypertensive disorders of pregnancy, including preeclampsia, months before symptoms occur. Rates of preeclampsia have nearly doubled in the United States over the last decade, and now affect 1 in 12 pregnancies.

“By the time a patient is symptomatic, it’s a race against the clock to try to get the baby to term and not risk the mother’s health,” said Dr. Kara Rood, a maternal-fetal medicine physician, one of the principal investigators of the study, and Clinical Associate Professor of Obstetrics and Gynecology at The Ohio State University Wexner Medical Center. “Current guidelines are not helping us identify which patients are truly at high risk and we need better tools. Mirvie’s preeclampsia risk prediction test can now improve risk assessment, helping women and their care teams be informed and take actions with the potential to delay onset or prevent the disease.”

Current guidelines from U.S. Preventive Services Taskforce and the American College of Obstetrics and Gynecology recommend the use of a set of risk factors known to be associated with preeclampsia and other HDPs, but these risk factors can be imprecise.

Mirvie’s blood test uses unique RNA signatures associated with two variants of preeclampsia to identify those who may be at highest risk. The paper also validates the predictive performance of Mirvie’s simple blood test to predict preeclampsia risk early, at 17.5 to 22 weeks gestational age, in pregnancies without any pre-existing high-risk conditions. This allows healthcare providers to more confidently implement an evidence-based prevention care plan to include low-dose aspirin and close clinical management in patients at highest risk.

“Over the last 100 years, we have relied on a reactive care model in pregnancy. This study represents a profound opportunity to move toward a proactive care model,” said Dr. Thomas McElrath, vice president of clinical development at Mirvie and a maternal-fetal medicine physician at Brigham and Women’s Hospital in Boston, MA. “Importantly, these results demonstrate for the first time the unique molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy, giving us confidence in a much more precise and personalized approach for at-risk pregnancies.”

Validation results show the simple blood test can identify 91% of pregnancies that will develop preterm preeclampsia in women aged 35+ without pre-existing high-risk conditions, months ahead of symptoms. Those with a low-risk result have 99.7% probability of not developing preterm preeclampsia. The clinically validated blood test will soon be broadly available under the brand name Encompass^TM.

“Patients and providers both desire better methods to determine preeclampsia risk,” said Eleni Tsigas, CEO of the Preeclampsia Foundation. “We're grateful for the continued partnership we have with Mirvie to further research and advocate with leaders in research and regulatory bodies for the development of tools like this to better predict, and one day prevent, conditions like preeclampsia.”

About the Mirvie RNA Platform

The Mirvie RNA platform combines advanced genomic analysis with machine learning and AI analysis to uncover the biology of developing pregnancies. The platform powered the company’s foundational, first-of-its-kind study uncovering defining molecular signatures of pregnancy complications. This comprehensive study examined the biology of nearly 11,000 representative pregnancies across the United States, analyzing 22,000 RNA transcripts per patient, translating into 200 million data points overall, making it the largest study of its kind. Mining the rich dataset is enabling the development of predictive risk blood tests across multiple pregnancy complications including preeclampsia, preterm birth, gestational diabetes, and fetal growth restriction. This personalized, predictive, and preventive approach to pregnancy care using RNA analysis can support pregnant women and their care teams to have the data needed to put an informed, personalized care plan in place months before a complication becomes a life-altering health crisis.

About Mirvie

Mirvie is bringing scientifically rigorous and data-driven approaches to solving some of the most pressing clinical problems in women’s health, beginning with pregnancy. Serious complications impact one in five pregnancies in the U.S., and Mirvie is committed to creating a world where every pregnancy is as safe and healthy as possible. Founded and led by a team of seasoned entrepreneurs and scientists, the company is based in South San Francisco, California and backed by top-tier investors including Blackrock, Decheng Capital, Foresite Capital, General Catalyst, GV, Khosla Ventures, and Mayfield. For more information, visit Mirvie.com.