In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved the first blood test designed to predict the risk of preeclampsia in pregnant women, a condition that affects 5-8% of pregnancies worldwide and is a leading cause of maternal and fetal mortality. The test, developed by Thermo Fisher Scientific, measures specific biomarkers linked to placental dysfunction, providing early warning signs weeks before symptoms appear.
Preeclampsia, characterized by high blood pressure and organ damage, typically arises after the 20th week of pregnancy and can progress rapidly, leading to life-threatening complications such as eclampsia (seizures) and HELLP syndrome. Until now, doctors relied on blood pressure monitoring and urine tests for proteinuria, which often detect the condition only after it has developed.
The new test, branded as Preecludia, analyzes two key proteins: soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF). An imbalance in these proteins indicates poor placental development, a hallmark of preeclampsia. Clinical trials involving over 10,000 pregnant women demonstrated that the test could accurately identify high-risk patients with 90% sensitivity, allowing for earlier interventions.
Dr. Emily Carter, an obstetrician at Johns Hopkins Hospital, praised the approval, stating, “This is a monumental advancement. Preeclampsia has always been a silent threat because we couldn’t predict who would develop it. Now, we can monitor high-risk women more closely and take preventive measures, such as low-dose aspirin or early delivery if necessary.”
The implications are particularly significant for Black and Hispanic women, who face disproportionately higher rates of severe preeclampsia due to systemic healthcare disparities. Early detection could help bridge this gap by enabling targeted care for vulnerable populations.
However, some experts caution that the test is not a standalone solution. “While it’s a powerful tool, it must be used alongside clinical evaluation,” said Dr. Rachel Nguyen, a maternal-fetal medicine specialist. “False positives could lead to unnecessary anxiety or interventions, so we need clear guidelines on how to integrate this into practice.”
Thermo Fisher Scientific has announced that Preecludia will be available in major U.S. hospitals by the end of the year, with plans for global expansion. The company is also researching additional biomarkers to improve accuracy further.
Beyond preeclampsia, this breakthrough paves the way for similar tests targeting other pregnancy complications, such as gestational diabetes and preterm birth. Researchers believe that precision medicine in obstetrics could revolutionize prenatal care, shifting the focus from reactive to proactive management.
You Might Be Interested In:
- Purple Sweet Potatoes Found to Enhance Gut Health and Reduce Inflammation
- Study Reveals Cruciferous Vegetables May Significantly Lower Cancer Risk
- New Study Links High-Dose Vitamin B6 to Improved Mental Health Outcomes
