FDA Breakthrough Device Designation

Mirvie receives FDA Breakthrough Device Designation for first test designed to indicate risk of preeclampsia months before symptoms occur

South San Francisco, CA - May 3, 2022

Mirvie, a pioneer in predicting unexpected pregnancy complications, today announced the company received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its test to indicate a woman’s individualized risk of developing preeclampsia before symptoms occur. The test is powered by the proprietary Mirvie RNA platform, which is designed to predict the risk of unexpected complications by revealing the underlying biology of each pregnancy.[1], [2]

Unexpected complications affect one in five pregnancies, with large economic costs and lifelong health consequences for expecting parents and babies.[3],[4],[5] They often leave families in a state of crisis and are a primary driver of childhood morbidity and mortality, frequently resulting in neonatal intensive care for the baby’s survival. [6] Pregnancy complications can double or even quadruple a mom’s lifetime risk of cardiovascular disease, regardless of how early the baby is born.[3],[4] Yet, women, expecting parents and doctors lack a reliable way to detect complications before symptoms appear.

The Mirvie Preeclampsia Test is the first test for the early identification of preeclampsia risk months before any clinical presentation of symptoms to receive FDA Breakthrough Device designation. The FDA’s Breakthrough Device program is intended to help expedite the development of medical technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

“This designation shows the FDA recognizes the chasm between what’s available to expecting parents and doctors today and the need for a breakthrough to address this enormous problem,” said Maneesh Jain, Ph.D., Co-Founder and CEO of Mirvie. “Pregnancy health must become proactive, preventive, and personalized for the wellbeing of expecting parents and babies. Ever-growing clinical evidence shows the Mirvie RNA platform is charting a new course to make that possible.”

Landmark research published in Nature (January 2022) provides preliminary evidence that the Mirvie RNA platform can identify 75% of women who go on to develop preeclampsia months before symptoms occur. [1] Additionally, research published in the American Journal of Obstetrics and Gynecology (April 2022) shows the platform can predict 76% of early preterm birth cases and identify distinct biological pathways driving its development.

“Prenatal care as we know it in the United States was first developed to primarily diagnose preeclampsia, yet these protocols have not changed in over fifty years,” said Eleni Tsigas, CEO of the Preeclampsia Foundation. “Moms and babies deserve more – there is an urgent need for innovation that not only identifies the risk of developing preeclampsia early, but also helps bring pregnancy health into the 21st century.”

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.  

With this designation, Mirvie will continue ongoing clinical research to further validate the Mirvie Preeclampsia Test performance and improve the understanding of preeclampsia.

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 $30 million in early-stage financing from top-tier investors, including Khosla Ventures, and Mayfield Fund. Mirvie is based in South San Francisco, California. To learn more about Mirvie, please visit www.mirvie.com.


[1]:Rasmussen, M., Reddy, M., Nolan, R. et al. RNA profiles reveal signatures of future health and disease in pregnancy. Nature 601, 422–427 (2022). https://doi.org/10.1038/s41586-021-04249-w
[2]: Camunas-Soler, J., Gee, E., Reddy, M., et al. LB 2: Early prediction of spontaneous preterm birth in a high-risk population using cfRNA profiling. American Journal of Obstretrics and Gynecology Vol. 226, Issue 1, Supplement , S779, January 01, 2022. https://doi.org/10.1016/j.ajog.2021.12.019
[3]: March of Dimes, Preeclampsia Foundation, IDF, CDC, WHO, UN, Sedgh et al., Reinebrant et al., McNair et al., Mirvie co-morbidity analysis.
[4]: Sedgh G, Singh S, Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann. (2014)
●      https://hcupnet.ahrq.gov/#setup for aggregate MDC14 and MDC15-related costs
●      https://www.ncbi.nlm.nih.gov/books/NBK11362/pdf/Bookshelf_NBK11362.pdf
●      https://pubmed.ncbi.nlm.nih.gov/28708975/
●      https://www.liebertpub.com/doi/pdfplus/10.1089/pop.2009.12303
●      https://healthcostinstitute.org/images/pdfs/iFHP_Report_2017_191212.pdf
●      https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/01/cesarean-delivery-on-maternal-request
●      All costs adjusted to 2020 dollars via https://www.in2013dollars.com/Medical-care/price-inflation/
●      EU grossed up from US based on https://ec.europa.eu/eurostat/statistics-explained/index.php/Government_expenditure_on_health and https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData with EU27 being 31% of total US health expenditures ($1.1T vs. $3.6T)
[6]:  https://www.who.int/news-room/fact-sheets/detail/preterm-birth

Media Contact:

Michelle Searer
FleishmanHillard for Mirvie