Mirvie has announced breakthrough results from a major study published in Nature Communications that demonstrates their RNA-based blood test can predict preeclampsia risk months before symptoms appear. The research, analyzing data from over 9,000 pregnancies in the multi-center Miracle of Life prospective trial, represents a significant advance in maternal healthcare at a time when preeclampsia rates have nearly doubled over the past decade.
Predictive Performance and Clinical Validation
The validation results show the blood test can identify 91% of pregnancies that will develop preterm preeclampsia in women aged 35 and older without pre-existing high-risk conditions. The test works by detecting unique RNA signatures at 17.5 to 22 weeks gestational age, months before clinical symptoms manifest. Those receiving a low-risk result have a 99.7% probability of not developing preterm preeclampsia.
"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 and principal investigator 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."
Molecular Signatures Distinguish Disease Severity
The study made a significant scientific breakthrough by identifying and confirming RNA signatures that can differentiate between severe and mild hypertensive diseases of pregnancy. This represents the first time unique molecular signatures have been demonstrated to distinguish between these conditions, providing a foundation for more precise and personalized pregnancy care.
"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," said Dr. Thomas McElrath, vice president of clinical development at Mirvie and a maternal-fetal medicine physician at Brigham and Women's Hospital.
Addressing Rising Preeclampsia Rates
Preeclampsia now affects 1 in 12 pregnancies, despite recent recommendations from the American College of Obstetrics and Gynecology and the U.S. Preventive Services Taskforce. Current risk assessment guidelines rely on factors that can be imprecise, leaving healthcare providers with limited tools to identify the 1 in 4 pregnancies that are actually at high risk.
The company notes that even among high-risk patients, less than 50% of pregnant women follow proven therapies such as daily aspirin. Early identification through blood testing could enable healthcare providers to implement evidence-based prevention care plans, including low-dose aspirin and close clinical management, months before symptoms appear.
Platform Technology and Future Applications
Mirvie's RNA platform combines advanced genomic analysis with machine learning and AI to uncover the biology of developing pregnancies. The platform analyzed 22,000 RNA transcripts per patient across nearly 11,000 representative pregnancies, generating 200 million data points in what the company describes as the largest study of its kind.
"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," said Maneesh Jain, co-founder and CEO of Mirvie.
Clinical Availability
The clinically validated blood test will soon be broadly available under the brand name Encompass. The development represents a shift from reactive to proactive pregnancy care, potentially transforming how healthcare providers approach maternal risk assessment and prevention strategies.
"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," McElrath noted.
