FDA Approves of New Blood Test To Detect Preeclampsia in Pregnant Women

The U.S. Food and Drug Administration (FDA) has approved a new blood test, which may be up to 96% accurate detecting preeclampsia, a life-threatening condition for pregnant women.

The test was created by Thermo Fisher Scientific Inc., and could have an important impact on medical care for pregnant women, by helping identify patients who are risk of developing preeclampsia within two weeks after taking the test

A study was published last year in the New England Journal of Medicine Evidence, which showed the high effective rate for the preeclampsia blood test.

“FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns,” said the co-author of the study, Ravi Thadhani, MD, MPH, in a press release issued by the manufacturer.

Researchers studied 1,000 pregnant women who were hospitalized with hypertensive disorder or preeclampsia. They studied two proteins in the blood to determine which mothers would develop preeclampsia. Women who had an imbalance of two proteins went on to have severe preeclampsia.

Patients who had the widest ratios of protein had a 65% chance of having severe preeclampsia and delivering their baby within two weeks of taking the test.

The new blood test could help determine which women face the highest risk of suffering from preeclampsia and who will have the highest risk of delivering their child early.

Preeclampsia Health Risks

Preeclampsia is a life-threatening condition for pregnant women if not treated early, potentially leading to seizures and strokes. It is often preceded by high blood pressure, diabetes, and kidney disease. It is also the leading cause of pregnancy-related death worldwide, largely because hospitals are unprepared to treat the condition.

One in 12 women in the United States have high blood pressure during pregnancy and 1 in 25 women will develop preeclampsia. It is a pervasive problem in the U.S. In fact, one-third of pregnancy-related deaths in the U.S. are linked to hypertensive disorders.

Preeclampsia normally develops about halfway through pregnancy. High blood pressure and increased protein levels in the urine can indicate the presence of the condition.

Preeclampsia can be hard to predict, but some symptoms include chronic high blood pressure, diabetes, decreased platelets in the blood, severe headaches, vision changes, shortness of breath, pain below the ribs, nausea, and vomiting.

According to the U.S. Centers of Disease Control and Prevention (CDC), there is no cure for preeclampsia, but the condition affects one in 25 pregnancies and more than 70,000 women worldwide every year. The rate of preeclampsia has increased by 25% over the past two decades.

Black women develop preeclampsia at rates much higher than white women and are three times as likely to suffer kidney damage or death from preeclampsia than white women. Infants born to mothers who suffer from preeclampsia face an increased risk of having a stroke or heart attack later in life.

The U.S. Preventative Services Task Force recommends early and regular blood pressure monitoring during pregnancy, especially for women of color, considering their increased risk.