Mirvie Announces Completion of Enrollment of 10,000 Person Landmark Research Study for Pregnancy Health

Study with leading physician-scientists will provide unprecedented insights into the underlying biology of pregnancy to identify those most at risk for adverse pregnancy complications that affect 1 in 5 pregnancies

SOUTH SAN FRANCISCO, Calif.--()--Mirvie, a company pioneering the prediction of life-threatening pregnancy complications months in advance, today announced the completion of enrollment of its landmark 10,000 person research study for pregnancy health, in collaboration with leading experts in obstetrics and maternal-fetal medicine.

“This monumental effort represents a new chapter for pregnancy health,” said Maneesh Jain, CEO and co-founder of Mirvie. “Today, we face a massive crisis in maternal health, and innovative solutions are desperately needed. The audacious scale of this generalizable study – involving over 10,000 individuals – creates the largest and richest biobank of pregnancy transcriptomes ever to exist.”

Led by internationally renowned experts in pregnancy health, the U.S.-based study seeks to understand how RNA messages found in expectant mothers’ blood can predict life-threatening pregnancy complications. One area of study relates to cell-free RNA’s prediction of preeclampsia months in advance, a leading cause of pregnancy-related morbidity and mortality which impacts an estimated 1 in 12 pregnancies in the U.S. Mirvie has included numerous study sites across the country, prioritizing geographically and racially diverse enrollment to ensure that this study represents the communities at greatest risk for adverse pregnancy outcomes. In addition to academic sites, the study includes community hospitals and direct-to-participant enrollment across 1,222 unique zip codes throughout the U.S.

“The geographical and racial diversity represented in our study is one of its greatest strengths,” said Dr. Joseph Biggio, maternal-fetal medicine specialist, system chair, and service line leader of Women’s Services of Ochsner Health in Louisiana, and principal investigator of the study at Ochsner Health in Louisiana. “With pregnancy complications disproportionately affecting communities of color, we are committed to increasing inclusion in research for individuals who have historically been underrepresented and underserved.”

Dr. Cynthia Gyamfi-Bannerman, maternal-fetal medicine specialist at UC San Diego Health and professor and chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California San Diego School of Medicine added, “This study will offer a vast data set in pregnancy health – including comprehensive clinical information and paired biospecimens – that may change the way we identify those at risk, and ultimately, how we improve care for adverse pregnancy complications.”

To learn more about the study, please visit https://clinicaltrials.gov/study/NCT06074601.

Mirvie is continuing a similar study in sub-Saharan Africa with support from the Bill and Melinda Gates Foundation, who awarded the company a $4.6 million grant earlier this year.

About The Mirvie RNA Platform

The proprietary Mirvie RNA platform combines revolutionary analysis of tens of thousands of RNA messages from the baby, the placenta and the mom, with machine learning. The platform opens a new window into pregnancy health for expecting parents to act and their doctors to intervene before unexpected complications become a crisis. It enables proactive, personalized and preventive pregnancy care for the well-being of expecting parents and babies. Mirvie is conducting ongoing clinical research to validate existing peer-reviewed evidence, to enhance the Mirvie RNA platform performance, and to improve the understanding of other pregnancy complications.

About Mirvie

Mirvie is shaping the future of pregnancy health by providing women, expecting parents and their doctors with an early detection window to intervene before unexpected pregnancy complications become a crisis. One in five pregnancies is impacted by complications that lead to lifelong health consequences for expecting parents and babies. The proprietary Mirvie RNA platform uses a simple blood test to reveal vital information about a pregnancy’s unique biology and detect complications months before they occur. The idea for Mirvie was sparked by the personal experience of one of the founders whose daughter was born prematurely. Mirvie’s team of world-class scientists and entrepreneurs have brought to market category-first, non-invasive tests in both women’s health and in early cancer detection, used by millions today. Founded in 2018, Mirvie has raised more than $90 million in early-stage financing from top-tier investors, including Decheng Capital, Foresite Capital, General Catalyst, GV, Khosla Ventures, and Mayfield. Mirvie is based in South San Francisco, California. To learn more about Mirvie, please visit www.mirvie.com.

Contacts

press@mirvie.com