FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

WEDNESDAY, July 5, 2023 (HealthDay News) -- A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk for this severe and sometimes deadly form of high blood pressure.

The test can identify with 96 percent accuracy which women with sometimes-vague symptoms will develop preeclampsia within the following two weeks, The New York Times reported this week.

"It's groundbreaking. It's revolutionary," Douglas Woelkers, M.D., a professor of maternal-fetal medicine at the University of California, San Diego, said of the test, according to The Times. "It's the first step forward in preeclampsia diagnostics since 1900, when the condition was first defined."

The blood test was created by Thermo Fisher Scientific. It is meant for women in the 23rd to 35th weeks of pregnancy. Those who do not test positive can be safely discharged from the hospital, while two-thirds of those with a positive result will advance to severe preeclampsia. Women who are positive may need to deliver their babies early.

"We don't have a therapy that reverses or cures preeclampsia other than delivery of the baby, which is more like a last resort," Woelkers said in the news report.

The test, which is already available in Europe, works by measuring the ratio of two proteins produced by the placenta. A study revealed those proteins were highly unbalanced in women who later developed severe preeclampsia. In that study, researchers tracked more than 1,000 pregnant women who were hospitalized at 18 medical centers between 2019 and 2021 with high blood pressure. The findings were published in NEJM Evidence.

The New York Times Article