Mirvie has launched Encompass, a solution that combines a blood test to predict personalized preeclampsia risk with preventive planning tools, the company announced today.
The product aims to transform prenatal care from reactive to proactive by identifying women at risk for preeclampsia—a condition affecting 1 in 12 pregnancies—months before symptoms appear. Encompass uses cell-free RNA measurements to evaluate placental health and pregnancy biology, providing risk assessment between 18-22 weeks of gestational age.
“For too long, we’ve relied on an outdated prenatal care model which has not kept up with the precision medicine approach common in other medical specialties,” said Maneesh Jain, CEO and Co-Founder of Mirvie. “Over the past decade, Mirvie has combined technological innovation with rigorous clinical evidence to deliver biological-data-driven approaches that usher in the era of predictive and preventive prenatal care. We’re thrilled that we can now help families with our work.”
The test is powered by the Mirvie RNA platform, which examined molecular health data from nearly 11,000 pregnancies across the United States. The company reports that in studies, the test identified 9 out of 10 pregnancies that later developed preterm preeclampsia as “high risk,” while those with a “low-risk” result had a 99.7% probability of not developing preterm preeclampsia.
“Patients should know their preeclampsia risk before it becomes a crisis,” said Dr. Thomas McElrath, Vice President of Clinical Development at Mirvie and a practicing maternal-fetal medicine physician at Brigham and Women’s Hospital. “The prenatal care model – designed nearly 100 years ago to manage preeclampsia – has remained largely unchanged. Encompass is a paradigm shift based on an increased understanding of the underlying biology of pregnancy.”
Pregnant individuals age 35 or older at delivery without pre-existing high-risk conditions for preeclampsia can currently purchase the test online. The process includes telehealth clinician review and mobile phlebotomy for at-home blood collection, with results delivered within 10-14 days.
Mirvie is launching Encompass across the United States (except New York) through direct-to-consumer channels while also working with physician offices, maternal health benefits providers, and payers to expand access.
The launch coincides with Preeclampsia Awareness Month, during which Mirvie is also introducing the #MotherofAllQuestions campaign to encourage expectant mothers to have informed conversations with their providers about pregnancy complications.
