SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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.
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.