Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device

May 11, 2022

South San Francisco, Calif.-based Mirvie has secured the FDA’s Breakthrough Device designation for its test to indicate a woman’s risk of developing preeclampsia during pregnancy.

The test is based on the company’s RNA screening platform, which is designed to predict the risk of complications by revealing the underlying biology of each pregnancy.

Preliminary research showed that the Mirvie RNA platform can identify 75 percent of women who go on to develop preeclampsia, months before symptoms occur, the company said.

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