FDA approves first blood test to predict life-threatening pregnancy condition preeclampsia

A historic leap forward in the quality of prenatal care is on the way, thanks to U.S. Food and Drug Administration (FDA) approving the first and only blood test in the country to predict preeclampsia in pregnancy. The test received a breakthrough designation from the FDA.

Preeclampsia is a potentially life-threatening condition that affects blood pressure and organ function in pregnant women. It also causes elevated levels of protein in the urine. According to the Centers for Disease Control and Prevention (CDC), preeclampsia affects about one in every 25 pregnancies in the United States.

Developed by Thermo Fisher Scientific, the test measures the levels of two proteins, PGF and sFlt-1, which are associated with severe preeclampsia. It can be processed in a hospital laboratory in 30 minutes. The biomarkers are indicators of placental health, predicting with 94 percent accuracy whether a pregnant person will develop severe preeclampsia within the next two weeks. The test is not for every pregnant person, but rather for those who have already been diagnosed with or have signs of preeclampsia.

Preeclampsia occurs on a spectrum, from a very mild elevation of blood pressure to deadly. The test will help healthcare providers identify who is most at risk for developing severe forms of the condition, which can include seizures (a condition called eclampsia), pre-term birth, and injury or fatality of both mother and baby.

“The purpose is to predict who will have severe preeclampsia,” says Anum Minhas, MD, an assistant professor of medicine at Johns Hopkins Medicine, who specializes in cardio-obstetrics and cardiovascular disease in women, in a statement according to Health. “In that case, those women may be hospitalized early to be monitored or need to have their babies early.”

Early detection, early intervention

With preeclampsia, the placenta does not form properly, usually during the first half of pregnancy. The disease is diagnosed after 20 weeks of pregnancy (the latter half of pregnancy) and may be detected for the first time in the early postpartum period. The placenta does not get enough blood supply. In response, it affects the mother’s blood vessels, causing high blood pressure. Early intervention can keep preeclampsia from becoming severe.

Women who are at elevated risk for preeclampsia are usually advised to take daily low-dose aspirin throughout their pregnancy, according to the American College of Obstetrics and Gynecology (ACOG). They recommend that high-risk mothers start taking the medication before 16 weeks gestation and continue until delivery.

In the U.S., the test is approved only for women who are between 23 and 34 weeks of pregnancy, which may leave some cases out. The test is used as early as the first trimester in Europe, however, and the developing agency is working to expand the test’s use during pregnancy for patients in the U.S.

Other factors to consider when diagnosing preeclampsia include how high a mother’s blood pressure is, and whether she has other signs or symptoms that could also increase her risk of severe preeclampsia.

With different pieces of information, doctors can make more informed decisions about which mothers may need more testing, which mothers may need hospitalization so they can be closely monitored, which can be discharged but potentially come in for more frequent check-ups, and which may need prompt delivery.

Risk factors for preeclampsia

Preeclampsia can develop in a perfectly healthy woman. There are some factors, however, that identify people at higher risk of developing preeclampsia, but the condition can also appear spontaneously. These risk factors include:

• Previous preeclampsia
• Being overweight
• Age 40 or older
• Multiple babies (twins, triplets)
• Diabetes
• Gestational diabetes
• Rheumatoid arthritis
• Migraine headaches
• Lupus
• Scleroderma
• Polycystic ovary syndrome
• Multiple sclerosis
• Sickle cell disease

Racial inequities in preeclampsia

Black women are 60 percent more likely to develop preeclampsia compared to other races.

The racial disparity has contributed to high rates of maternal mortality in the U.S., specifically among Black mothers. CDC data shows that in 2021, Black mothers were 2.6 times as likely to die in pregnancy compared to White mothers.

For new diagnostic tools to be used equitably, the U.S. healthcare system will first need to address systemic issues that prevent people of color from getting equal care.

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