South San Francisco, CA (January 30, 2025) - Mirvie, a pioneer in bringing a personalized, predictive, and preventive approach to serious pregnancy complications, today announced at the Society for Maternal-Fetal Medicine annual meeting that the Mirvie RNA platform has uncovered a unique molecular signature predictive for babies born with severe growth restriction. Unrecognized fetal growth restriction is the single largest risk factor for stillbirth. 

Drawing upon the largest molecular study of pregnancy completed to date, researchers examined more than 5,000 geographically and demographically diverse pregnancies. Analyzing millions of maternal, fetal, and placental RNA messages using the Mirvie RNA platform, the technology was able to distinctly predict babies born with severe forms of growth restriction. Key findings include:

Researchers successfully predicted 60% of babies with severe fetal growth restriction months in advance of delivery, a significant improvement over the current standard of care

Current clinical risk factors used today, like advanced maternal age, maternal height, smoking status, and obesity are not predictive. 

The Mirvie RNA Platform found severe growth restriction has a unique RNA signature independent of preeclampsia, chronic hypertension, and gestational diabetes, all of which can impact fetal growth. 

“Similar to the breakthroughs that propelled the molecular understanding of breast cancer in the 1990s, obstetrics can now move towards a new standard of care based on the molecular characteristics of each pregnancy,” said Maneesh Jain, CEO and co-founder of Mirvie. “With the Mirvie RNA Platform, we can move toward a proactive and personalized care approach in maternal health that focuses on preventing serious pregnancy complications.”

“There’s a large unmet need to better identify babies most at risk for stillbirth and other negative outcomes as indicated by poor growth because the majority are undiagnosed before birth,“ said Dr. Kara Rood, a maternal-fetal medicine specialist and Clinical Associate Professor of Obstetrics and Gynecology at The Ohio State University Wexner Medical Center and principal investigator of the study who presented the findings. “Approximately 70% of babies with severe growth restriction - characterized as babies in the <third percentile for growth and at highest risk for stillbirth - are missed by a standard ultrasound. This leads to overtreatment and extra monitoring for those who don’t need it and insufficient monitoring and intervention for those who do. These novel findings powered by the Mirvie RNA platform are exciting and helping the field achieve this goal.” 

“At a molecular level, we now understand how biology impacts which pregnancies are at highest risk for poor outcomes,” said Dr. Thomas McElrath, vice president of clinical development at Mirvie and a practicing maternal-fetal medicine physician at Brigham Women’s Hospital. “This breakthrough removes the bias and variability associated with clinical risk factors and assessments currently used to determine which babies may be at highest risk for fetal growth restriction. With a worsening maternal health crisis, we need innovative tools like Mirvie’s RNA platform to change the status quo and create better outcomes for mothers and babies.”

Evidence-based interventions can be used by physicians and care teams if a pregnancy is identified as high-risk for severe fetal growth restriction, including:

An etiology workup, deploying genetic testing like NIPT, amniocentesis, infectious testing and evaluating for structural anomalies

Serial ultrasounds to monitor growth frequently during pregnancy

Doppler studies can show if blood flow through the placenta and fetus is becoming impaired and decreasing over time

Increased fetal monitoring

Scheduled induction or C-section delivery depending on growth restriction and results from testing to prevent stillbirth testing

The novel findings add to the growing body of research demonstrating the use of the Mirvie RNA platform to predict pregnancy complications months before symptoms appear, including preeclampsia risk prediction in Nature and preterm birth risk prediction in the American Journal of Obstetrics and Gynecology. 

About Mirvie RNA Platform

Mirvie’s RNA platform has powered the company’s foundational, first-of-its-kind study uncovering the biology of pregnancy health. This comprehensive study examined the biology of nearly 11,000 diverse pregnancies across the United States, collecting more than 20,000 RNA transcripts per patient and translating into 200 million data points overall. Mining the rich dataset with advanced machine learning and AI, Mirvie is unlocking the underlying biology of pregnancy health. The Mirvie RNA platform delivers predictive blood tests that enable preventive care across multiple pregnancy complications such as preeclampsia, preterm birth, and fetal growth restriction. 

About Mirvie

Mirvie is bringing a personalized, predictive, and preventive approach to pregnancy health using RNA to predict the risk of serious complications like preeclampsia, preterm birth and fetal growth restriction, months in advance. Backed by rigorous clinical research, the proprietary Mirvie RNA platform reveals actionable information about the unique biology of a pregnancy with a simple blood test. This breakthrough allows pregnant women and their care teams to put a preventive action plan in place before a complication becomes a life-altering crisis. 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. Mirvie is backed by top-tier investors including Blackrock, Decheng Capital, Foresite Capital, General Catalyst, GV, Khosla Ventures, and Mayfield. For more information, visit Mirvie.com.

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