Mirvie Announces Results from Largest Molecular Study in Pregnancy and Clinical Validation of Simple Blood Test to Predict Risk for Preeclampsia Months Before Symptoms

Associated Press

08-04-2025

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr 8, 2025--
Today, Mirvie announced results of a breakthrough study published in Nature Communications, revealing 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 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. The paper also validates the predictive performance of Mirvie's simple blood test to predict preeclampsia early, at 17.5 to 22 weeks gestational age, in pregnancies without any pre-existing high-risk conditions.
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'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.'
Despite current guidelines from U.S. Preventive Services Taskforce and The American College of Obstetricians and Gynecologists that use general maternal characteristics to identify pregnant women at increased risk for preeclampsia, rates of the disease have nearly doubled in the last decade and now affect 1 in 12 pregnancies. Mirvie's blood test uses RNA signatures to resolve this ambiguity, helping pregnant women and their providers focus on the 1 in 4 pregnancies that are truly at high risk, ensuring optimal care for the right patients. The results of this study demonstrate that relying on molecular signals from the underlying biology is far more effective in determining whether risk for preeclampsia is high or low.
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 ™.
'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.'
Today, the adherence to known valuable interventions for pregnancies at high risk of preeclampsia such as daily aspirin is less than 50%, even among high-risk patients. With a simple blood test available early in the second trimester, pregnant patients and care teams can intervene months before symptoms and more confidently implement an evidence-based prevention care plan to improve the chance for a full-term pregnancy and healthy delivery.
'We are thrilled with the results from our investments in this critical research and collaboration with more than a dozen internationally renowned experts in maternal-fetal medicine,' added Maneesh Jain, co-founder and CEO of Mirvie. 'Much like the discovery of molecular subtypes of breast cancer led to improved outcomes, the discovery of molecular subtypes in HDP offers a bright future for personalizing pregnancy care and addressing the rising rates of births with complications.'
The novel findings add to the growing body of research demonstrating the use of the Mirvie RNA platform to predict pregnancy complications months in advance, including studies on preeclampsia risk prediction in Nature and preterm birth risk prediction in the American Journal of Obstetrics and Gynecology and research presented in January at the Society for Maternal-Fetal Medicine conference on prediction of fetal growth restrictio n.
About the Mirvie RNA Platform
The Mirvie RNA platform combines advanced transcriptomic 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 cell-free 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 cell-free 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.
SOURCE: Mirvie
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PUB: 04/08/2025 08:31 AM/DISC: 04/08/2025 08:31 AM