The FDA has approved a blood test for preeclampsia, a blood-pressure disease in pregnancy.
It's the first test developed to predict the potentially deadly condition.
About one in 25 US pregnancies is affected, and the disease disproportionately affects Black women.
The Food and Drug Administration has approved a blood test that predicts a pregnant person's risk of developing a severe blood-pressure disease.
The condition, called preeclampsia, occurs when a person develops high blood pressure after 20 weeks of pregnancy. It's a leading cause of maternal death and disability worldwide. The rate of preeclampsia in the US has jumped 25% in the past two decades, according to the nonprofit Preeclampsia Foundation.
About one in 25 pregnancies in the US is affected by preeclampsia, according to the Centers for Disease Control and Prevention. The disease can damage organs including the kidneys, liver, and brain, and might increase the pregnant person's risk of preterm birth and pregnancy loss.
Thermo Fisher Scientific developed the blood test, which is already available in Europe. The FDA granted the test approval in May.
The test is designed to be given to pregnant people who have been hospitalized for blood pressure disorders. Per Thermo Fisher Scientific, the test helps determine those patients' risks of developing preeclampsia by measuring the balance of two proteins in the blood.
The wider the ratio of those proteins, the greater likelihood that patient has of developing severe preeclampsia. Patients studied with the widest ratios of the proteins had about a two-thirds chance of developing the disease and giving birth within two weeks of the test.
"It's groundbreaking. It's revolutionary," Dr. Doug Woelkers, a professor of maternal fetal medicine at the University of California, San Diego, told The New York Times about the test. "It's the first step forward in preeclampsia diagnostics since 1900, when the condition was first defined."
Preeclampsia also disproportionately affects Black pregnant people: Pregnant Black women are about five times more likely than white women to die from cardiovascular disorders including preeclampsia and eclampsia.
The Preeclampsia Foundation says about six in 10 of deaths related to preeclampsia are preventable.
People with preeclampsia often experience prolonged headaches, vision problems, nausea, trouble breathing, sudden weight gain, or swelling in the face or hands.
Others with preeclampsia experience no symptoms, making regular visits to the doctor during pregnancy even more important — and underlining the value of a blood test to detect the disease.
Severe cases of preeclampsia can progress to eclampsia, a disease marked by seizures that can cause the pregnant person to go into a coma, posing a significant threat to the patient and the baby.
There is no cure for preeclampsia besides giving birth. Preeclampsia treatments can include medications to lower the pregnant person's blood pressure, as well as drugs to mediate or prevent related complications like seizures.
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