Labcorp (NYSE: LH), a renowned provider of cutting-edge and all-encompassing laboratory services globally, has introduced and made accessible a recently FDA-cleared blood test. This test is designed for evaluating the risk and overseeing the clinical aspects of severe preeclampsia, a potentially life-threatening blood pressure disorder prevalent during pregnancy and the postpartum period.
Preeclampsia, a condition exclusive to pregnancy affecting 2-5% of pregnancies and a significant contributor to maternal and neonatal morbidity and mortality in the United States, has prompted the development of a groundbreaking test. Traditional diagnostic methods for preeclampsia, such as blood pressure and proteinuria evaluation, have proven insufficient in predicting severe adverse outcomes for both mothers and newborns.
The recently unveiled test, crafted by Thermo Fisher Scientific and recognized as one of TIME Magazine’s Best Inventions of 2023, gauges two angiogenic biomarkers linked to preeclampsia: serum soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF).
The test outcome, represented as a ratio of these two biomarkers, coupled with additional laboratory tests and clinical assessments, aids clinicians in identifying pregnant patients admitted for hypertensive disorders at risk of progressing to severe preeclampsia within the following two weeks. This validation stems from the PRAECIS study, encompassing over 1,000 pregnant women across 18 U.S. hospitals.
Tailored for use in singleton pregnancies between 23+0 and 34+6/7 weeks gestation, the blood-based test offers enhanced surveillance and expedited care for pregnant women testing positive based on the risk stratification sFlt-1/PlGF ratio ≥ 40, alongside other disease indicators, thus enabling proactive management before severe features manifest.
Marcia Eisenberg, Ph.D., Senior Vice President and Chief Scientific Officer at Labcorp, expressed Labcorp’s pride in collaborating with Thermo Fisher to introduce this test. Positioned for application in the second and third trimesters, it provides critical, early, and objective insights for managing preeclampsia. This development aligns with Labcorp’s commitment to delivering a comprehensive range of advanced diagnostic tests, empowering patients and providers with clinically significant information to enhance outcomes for parents and their newborns.
