Mirvie, a leader in uncovering the biology and utilizing data-driven approaches to improve the care of women’s health conditions, recently announced the launch of its first breakthrough product for preeclampsia, one of the most common and serious pregnancy complications. Encompass combines a novel blood test to predict personalized preeclampsia risk with a preventive action plan and a responsive virtual assistant to offer pregnant women individualized support and help them work with their care team towards the healthiest pregnancy possible.
Preeclampsia, impacting 1 in 12 pregnancies with rates continuing to grow, is one of the most challenging pregnancy complications, but also one with a comprehensive, evidence-based care plan to reduce the risk of developing the condition or delaying onset late enough in pregnancy to avoid preterm birth. Until now, no simple and effective clinical tools have existed to predict the risk of who will develop the condition. As a result, prenatal care has relied on a ‘wait and see’ approach that looks for symptoms and then reacts once the condition develops. This lack of specificity results in poor consumer attitudes and clinical resource constraints – explaining why adherence of preventive interventions such as daily aspirin is less than 10%.
“For too long, we’ve relied on an outdated prenatal care model which has not kept up with the precision medicine approach common in other medical specialties,” said Maneesh Jain, CEO and Co-Founder of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.”
Mirvie’s Encompass test for preeclampsia analyzes cell-free RNA measurements to evaluate placental health and the biology of the developing pregnancy to predict which pregnancies are at risk for preeclampsia. Studied in landmark research and powered by the Mirvie RNA platform™, which examined the molecular health of nearly 11,000 pregnancies across the U.S., the test predicted 9 of 10 pregnancies that later developed preterm preeclampsia as “high risk.” Those with a “low-risk” result have 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. With Encompass, pregnant women with a high-risk result can have conversations with their care teams about interventions to mitigate risk, including additional monitoring, aspirin adherence, monitoring blood pressure at home, and more. Encompass allows optimal, personalized care for the right patients.”
Mirvie is launching Encompass across the U.S.* with an easy, direct-to-consumer online purchase process, telehealth clinician review, mobile phlebotomy, and results delivered within 10-14 days. Initially, Encompass is available to purchase for expecting moms ages 35 and older at delivery without pre-existing high-risk conditions for preeclampsia. The company is also working with third parties, including physician offices, maternal health benefits providers, and payers to add new access channels.
“With this launch, we are moving urgently to respond to the dire maternal health crisis and also embracing very positive structural changes happening in healthcare,” said Aimee Corso, Senior Vice President of Growth at Mirvie. “Consumer demand and willingness to pay for innovation are at an intersection with constrained OB/GYN resources and the clinical movement to personalize maternity care. Our easy, patient-centric, ecommerce experience helps expectant moms meet their needs while also reducing burdens on their providers, enabling the most productive office visits possible.”
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