FDA approves groundbreaking blood test for early preeclampsia detection in pregnant women

The FDA has approved a new blood test that can detect whether a mother will potentially get preeclampsia within 30 minutes. Preeclampsia is a dangerous complication that can occur in pregnant women, characterized by high blood pressure. The test could save lives in a state where women are twice as likely to die from pregnancy-related causes as in other states. According to the CDC, from 2018 to 2021, Georgia had the seventh-highest rate of maternal deaths in the nation. Additionally, Black women are also 3-5 times more likely to get preeclampsia than white women.

Dr. Padmashree "Champa" Chaudhury Woodham, the President of the Georgia OBGYN Society and Professor of Maternal-fetal medicine at Augusta University- Medical College of Georgia, said, "Unfortunately, one of the leading causes is hypertensive disorders in pregnancy, among which is pre-eclampsia."

She expressed her excitement about the FDA's approval of the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, developed by Thermo Fisher Scientific. As a high-risk O.B. doctor, she frequently deals with patients who have pre-eclampsia, and this new test could be a game changer.

Dr. Ravi Thadhani, Executive Vice President for Health Affairs at Emory University, emphasizes the critical importance of detecting preeclampsia quickly. He was involved in the study that led to the FDA's approval of the new blood test. Dr. Thadhani pointed out that the test not only quickly determines whether someone may be at risk for preeclampsia, but it does so very accurately. He said, "This test has over a 95% negative predictive value, and in African-American women, 99%. In other words, if the test is negative, the chance of her getting sick in the next two weeks is less than 1% in African-American women and less than 5% in Caucasian women."

This means that the chances of saving these women's lives dramatically increase. However, it's important to note that right now, the FDA approval is just for hospital use.

Dr. Woodham advises pregnant women to watch out for certain symptoms of preeclampsia. She said, "If they are able to check their blood pressure and they have elevated blood pressure, which is defined as anything over 140 for the systolic blood pressure or 90 for the diastolic, they should be concerned. Additionally, symptoms like a persistent headache, pain on the right upper side of their belly or in the middle upper part of their belly, or visual changes like blurry vision are all potential signs of pre-eclampsia."