Labcorp, a global leader of innovative and comprehensive laboratory services, has officially announced the launch of its trimester preeclampsia screening test, which is performed between 11 and 14 weeks gestation. The stated test is basically done to determine the risk of developing preeclampsia before 34 weeks of pregnancy. In case you weren’t aware, preeclampsia is a high blood pressure disorder that can develop during pregnancy or postpartum, a disorder that is currently a leading cause of maternal morbidity and mortality worldwide. To give you some context, roughly one in every 25 pregnant women across US is affected by preeclampsia. Within this contingent, the disease poses, markedly enough, an even greater risk for non-Hispanic Black women, who experience the condition at a 60% higher rate compared to white women. Hence, addressing the given very problem, Labcorp’s latest test is relevant for all pregnant individuals, including those with a low- to average-risk for preeclampsia, or the ones experiencing pregnancy first time. But how does it go about its job on a more practical note? Well Labcorp’s first trimester test uses four key early pregnancy biomarkers to provide a comprehensive risk assessment with up to 90% sensitivity. This is nearly twice the sensitivity of assessing typical maternal history or biophysical factors alone. Anyway, a detail we must mention here is that the test provides risk identification earlier than the onset of traditional symptoms like hypertension or protein in the urine, which tend to develop around 20 weeks gestation.
At present, Labcorp is the only laboratory to offer tests that screen preeclampsia risk across all trimesters of pregnancy.
“Labcorp is committed to advancing maternal and fetal health through innovative diagnostic and screening solutions,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “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.”
More on the stated value proposition would reveal how it produces a risk score by measuring two biochemical markers i.e. placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A). Apart from that, it also uses two biophysical markers – mean arterial pressure (MAP) and uterine artery pulsatility index (UtAPI). In simpler terms, low levels of PlGF and PAPP-A indicate poor placental development and function, whereas high MAP and UtAPI levels indicate high blood pressure and elevated resistance to blood flow across the uterine artery.
The development of Labcorp’s latest brainchild is largely concerned with two principal studies, where researchers observed significant benefits of placing maternal factors alongside biomarkers for early screening. You see, one of these studies, named SPREE, was a large prospective multicenter study of 16,700 women. In essence, SPREE would go on to report that the combination of MAP, UtAPI, PlGF and PAPP-A yielded substantially improved screening performance than standard screening guidelines. On the other hand, the second study, which was named ASPRE, a first trimester multicenter study of screening for preterm preeclampsia among more than 25,000 pregnant women. After combining multimarker screening and randomized patient treatment with aspirin for evidence-based preeclampsia prevention, the study reached a conclusion that the use of MAP, UtAPI, PlGF and PAPP-A as screening factors can be an effective alternative to treat preeclampsia moving forward.
“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.”