Mirvie has announced results from a study published in Nature Communications that advances the biological understanding of hypertensive disorders of pregnancy (HDP), including preeclampsia. The research utilized data from more than 9,000 pregnancies within the multi-center Mirvie-sponsored Miracle of Life prospective study.
The study discovered and validated RNA signatures capable of distinguishing between severe and mild hypertensive disorders of pregnancy months before symptoms occur. The research also validates the performance of Mirvie’s blood test to predict preeclampsia early, at 17.5 to 22 weeks gestational age, in pregnancies without pre-existing high-risk conditions.
“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 Obstetrics and Gynecology, rates of preeclampsia have nearly doubled in the last decade and now affect 1 in 12 pregnancies. Mirvie’s blood test uses RNA signatures to help pregnant women and their providers focus on the 1 in 4 pregnancies that are truly at high risk.
The validation results show the 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 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.”
The company notes that adherence to known interventions for pregnancies at high risk of preeclampsia, such as daily aspirin, is less than 50%, even among high-risk patients. With a blood test available early in the second trimester, pregnant patients and care teams can intervene months before symptoms and implement an evidence-based prevention care plan.
“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.”
