CLIA Certification

Mirvie becomes first RNA-based pregnancy health-focused company to receive clinical laboratory improvement amendments (CLIA) certification

South San Francisco, CA - September 26, 2023

Mirvie, a pioneer in predicting unexpected  pregnancy complications, today announced its South San Francisco-based laboratory has been  certified by the Centers for Medicare and Medicaid Services (CMS) under the Clinical  Laboratory Improvement Amendments (CLIA) to perform high-complexity clinical testing.

“We are extremely proud to have received CLIA certification, which marks a crucial milestone in  our journey towards commercializing the Mirvie RNA platform,” said Maneesh Jain, Co-Founder  and CEO of Mirvie. “Our recent grant from the Bill and Melinda Gates Foundation, coupled with our FDA Breakthrough Device Designation last year and now CLIA certification, has given us  significant momentum. We are thrilled to be closer to offering expectant parents and their  clinicians an advanced, evidence-based RNA platform to predict and help prevent pregnancy  complications.”

The CLIA certification process of Mirvie’s laboratory ensures high quality service including  testing personnel, operations, quality control, and assurance.

Mirvie predicts life-threatening complications months in advance using a patented RNA platform  to reveal each pregnancy’s underlying biology. Via a simple blood test from the mom, the Mirvie  RNA platform screens for the risk of multiple pregnancy-related complications, giving expectant parents a clear path to creating the healthiest pregnancy outcome possible. Research  demonstrating early performance of the platform has been published in Nature and the  American Journal of Obstetrics and Gynecology and Mirvie has clinical validation studies  currently in progress.

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

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