Starting with preeclampsia, new solution aims to transform the pregnancy experience from reactive to personalized, proactive and preventive by predicting risk for complications months before symptoms appear
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Mirvie, a leader in uncovering the biology and utilizing data-driven approaches to improve the care of women’s health conditions, today 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“For too long, we’ve relied on an outdated prenatal care model which has not kept up with the precision medicine approach common in other medical specialties,” said Maneesh Jain, CEO and Co-Founder of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.”
A few things to know about Encompass:
Accessible: Purchasing the test is simple — pregnant individuals age 35 or older (at time of delivery) can purchase from encompasstest.com, and a licensed telehealth provider will review and approve the test order.
Simple and convenient: A simple blood sample is collected through an at-home visit between 18-22 weeks of gestational age, without needing a trip to the lab.
Actionable: Results are returned within 10-14 days to the mom and her provider care team, paired with a preventive action plan and responsive virtual assistant, to help reduce the risk of developing preterm preeclampsia.
As part of the product launch and with May marking Preeclampsia Awareness Month, Mirvie is also announcing the launch of the #MotherofAllQuestions campaign to shed light on how expecting moms can prepare themselves with the right solutions, data, and questions to have authentic conversations with their providers about their pregnancy journey and understand their risk for dangerous complications like preeclampsia. Visit Mirvie and Encompass social channels to take part in the campaign and learn how to tackle the tough conversations in pregnancy because knowledge is crucial for having the healthiest pregnancy possible.
Visit EncompassTest.com to determine if you’re eligible to purchase the test today.
About the Mirvie RNA Platform
The Mirvie RNA platform combines advanced transcriptomic analysis with machine learning and AI analysis to uncover the biology of developing pregnancies. The platform powered the company’s foundational, first-of-its-kind study uncovering defining molecular signatures of pregnancy complications. This comprehensive study examined the biology of nearly 11,000 representative pregnancies across the United States, analyzing 22,000 cell-free RNA transcripts per patient, translating into 200 million data points overall, making it the largest study of its kind. Mining the rich dataset enables Mirvie to focus on the development of predictive risk blood tests across multiple pregnancy complications including preeclampsia, preterm birth, and fetal growth restriction. This personalized, predictive, and preventive approach to pregnancy care using cell-free RNA analysis can support pregnant women and their care teams to have the data needed to put an informed, personalized care plan in place months before a complication becomes a life-altering health crisis.
About Mirvie
Mirvie is bringing scientifically rigorous and data-driven approaches to solving some of the most pressing clinical problems in women’s health, beginning with pregnancy. 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. Founded and led by a team of seasoned entrepreneurs and scientists, the company is based in South San Francisco, California and backed by top-tier investors including Blackrock, Decheng Capital, Foresite Capital, General Catalyst, GV, Khosla Ventures, and Mayfield. For more information, visit Mirvie.com.
*=Available in service areas across the United States, except New York
Contacts
Kate Enos
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