Blood test for preeclampsia granted FDA approval

Blood test for preeclampsia granted FDA approval | Image Credit: © Grandbrothers - © Grandbrothers - stock.adobe.com.

The FDA has approved a test for screening preeclampsia in pregnant women.

Preeclampsia is a complication present in 1 in 25 pregnancies and is more often seen in Black women than White women.¹ The condition causes high blood pressure and protein in the urine which can cause kidney and liver damage. Severe preeclampsia may be fatal in some patients.

Over the past 25 years, the prevalence of preeclampsia has risen by 25%, and it is currently the leading cause of maternal mortality and disability worldwide.² It also increases the risks of preterm birth and pregnancy loss.

Diagnosing preeclampsia has been historically difficult, as there have been no certain methods developed for determining preeclampsia risk, presence, or severity.¹ Risk factors of preeclampsia include high blood pressure, diabetes, or obesity before pregnancy, prior preeclampsia, and multiple gestation.

Symptoms include swollen hands, swollen feet, headache, nausea, fatigue, blurry vision, and rapid weight gain. Many patients associate these symptoms with pregnancy and are unaware they are caused by preeclampsia.

The risk of preeclampsia is 60% higher in Black women, kidney problems are 3 times more likely, and the risk of failed pregnancy is increased. Investigators have predicted these disparities may be caused by social, cultural, and biological issues, but are uncertain.

The new blood test measures the 2 proteins put out by the placenta to determine preeclampsia presence. A normal ratio between the 2 proteins indicates a patient does not have preeclampsia, while a disproportionate ratio indicates increased preeclampsia risk, with a direct correlation between the disproportion and risk.

This blood test was developed by Thermo Fisher Scientific and granted approval by the FDA in May 2023.² It was designed for use in pregnant patients in the hospital with blood pressure disorders.

Delivery is the primary cure for preeclampsia, leading doctors to keep patients at risk of severe preeclampsia in the hospital. As an estimated 6 in 10 deaths from preeclampsia are preventable, the ability to measure severe preeclampsia risk could be lifesaving in many patients.

Reference

1. FDA approves blood test to predict pre-eclampsia in pregnant people. Today. July 4, 2023. Accessed July 5, 2023. https://www.today.com/video/fda-approves-blood-test-to-predict-pre-eclampsia-in-pregnant-people-186755141593
2. The first test for predicting preeclampsia in pregnant people won FDA approval more than 100 years after researchers discovered the blood-pressure disease. Insider. July 4, 2023. Accessed July 5, 2023. https://www.insider.com/first-test-for-preeclampsia-risk-gets-fda-approval-2023-7