FDA Clears Blood-Based Biomarker Tests for Risk Assessment of Preeclampsia

The Food and Drug Administration (FDA) has cleared the first blood-based biomarkers for risk assessment and clinical management of preeclampsia, a leading cause of maternal and fetal mortality and morbidity.

The Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR biomarkers are designed to assess the risk of progressing to preeclampsia with severe features within the coming 2 weeks in pregnant women who have been hospitalized for hypertensive disorders of pregnancy. These assays run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer; results can be delivered in less than 30 minutes.

The FDA clearance was based on data from the PRAECIS study (ClinicalTrials.gov Identifier: NCT03815110), which included more than 700 pregnant women hospitalized with hypertensive disorder presenting between 23 and 35 weeks of gestation. Results showed that women with a ratio serum soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) of at least 40 were at higher risk for adverse maternal outcomes compared with those with a ratio less than 40 (16.1% vs 2.8%; relative risk, 5.8; 95% CI, 2.8–12.2).

“FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns,” said Ravi Thadhani, MD, MPH, executive vice president of health affairs at Emory University and co-author of the PRAECIS study.