Original from: Labcorp

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch of its first trimester preeclampsia screening test to be performed between 11 and 14 weeks gestation to determine the risk of developing preeclampsia before 34 weeks of pregnancy. It is the only test of its kind available in the United States and is relevant for all pregnant individuals, including those with a low- to average-risk for preeclampsia or first-time pregnancies.

Preeclampsia is a high blood pressure disorder that can develop during pregnancy or postpartum and is a leading cause of maternal morbidity and mortality worldwide. Roughly one in 25 pregnancies in the U.S. is affected by preeclampsia, which poses an even greater risk for non-Hispanic Black women, who experience the condition at a 60% higher rate compared to white women.

With this test launch, Labcorp is now the only laboratory to offer tests that screen for preeclampsia risk across all trimesters of pregnancy. In January, Labcorp announced the launch and availability of an FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia during the second and third trimesters.

"Our organization celebrates this innovative new test offering," said Eleni Tsigas, Chief Executive Officer of the Preeclampsia Foundation. "Research shows that patients and providers want access to more tools that better predict progression to preeclampsia, especially for those patients with low- to average-risk or those with first-time pregnancies for whom there is some uncertainty."

The first trimester test uses four key early pregnancy biomarkers to provide a comprehensive risk assessment with up to 90% sensitivity, nearly twice the sensitivity of assessing typical maternal history or biophysical factors alone. The test results provide risk identification earlier than traditional symptoms such as hypertension or protein in the urine, which tend to develop around 20 weeks gestation.

The blood-based test produces a risk score by measuring two biochemical markers – placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) – and two biophysical markers – mean arterial pressure (MAP) and uterine artery pulsatility index (UtAPI). Low levels of PlGF and PAPP-A indicate poor placental development and function, while high MAP and UtAPI levels indicate high blood pressure and elevated resistance to blood flow across the uterine artery.

"Labcorp is committed to advancing maternal and fetal health through innovative diagnostic and screening solutions," said Dr. Brian Caveney, Labcorp's Chief Medical and Scientific Officer. "This new first trimester blood test is another significant milestone in our mission to improve health and improve lives. By giving healthcare providers another tool to assess preeclampsia risk in their pregnant patients with objective biomarkers, we're helping to advance prenatal care and improve outcomes for mothers and their babies."

Labcorp's test is based on published data from two principal studies, demonstrating the significant benefits of combining maternal factors with biomarkers for early screening. The SPREE study (Screening Program for Pre-eclampsia), a large prospective multicenter study of 16,700 women, reported that the combination of MAP, UtAPI, PlGF and PAPP-A yielded substantially improved screening performance than standard screening guidelines. The ASPRE trial (Combined Multimarker Screening and Randomized Patient Treatment with Aspirin for Evidence-Based Preeclampsia Prevention), a first trimester multicenter study of screening for preterm preeclampsia among more than 25,000 pregnant women, validated the use of MAP, UtAPI, PlGF and PAPP-A as screening factors.

The new first trimester test is the latest offering from Labcorp in its commitment to advance women's health by providing innovative tests, resources and services to support each stage of an individual's health journey. Among these services, Labcorp offers support to millions of women through its digital health platform, Ovia Health by Labcorp. Through its family of apps, Ovia offers evidence-based, clinically informed content and simple, convenient tools, including a preeclampsia prevention and management program, which provides members with clear, actionable guidance to help them understand their risk to make better health decisions that support a healthy pregnancy.

Source: Labcorp Introduces First Trimester Screening Test to Assess Preeclampsia Risk during Pregnancy