Global life sciences company Labcorp has launched its first trimester screening test for assessing preeclampsia risk during pregnancy in the US.
The new screening test, which needs to be conducted between 11 and 14 weeks of gestation, is designed to assess the risk of preeclampsia development before 34 weeks of pregnancy.
It is said to be the only test currently available in the US that can detect preeclampsia risk across all pregnancy trimesters.
The test is particularly relevant for all pregnant individuals, including those with a low to average risk for preeclampsia or those experiencing their first pregnancy.
It utilises four early pregnancy biomarkers for delivering a comprehensive risk assessment with a sensitivity of up to 90%.
This is nearly double the sensitivity of traditional assessments based on maternal history or biophysical factors alone.
The blood-based test generates a risk score by measuring placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) biochemical markers and two biophysical markers – mean arterial pressure (MAP) and uterine artery pulsatility index (UtAPI).
The levels of these markers are indicative of placental development and function, as well as blood pressure and blood flow resistance in the uterine artery.
Labcorp said the test is supported by data from two key studies. The SPREE study, a large prospective multicentre study involving 16,700 women, found that the combination of MAP, UtAPI, PlGF, and PAPP-A significantly improved screening performance compared to standard guidelines.
Additionally, the ASPRE trial, which involved screening for pre-term preeclampsia in over 25,000 pregnant women, validated the use of these four factors as effective screening markers.
Labcorp chief medical and scientific officer Dr Brian Caveney said: “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.”
Last month, Labcorp announced commercial launch of glial fibrillary acidic protein (GFAP) blood biomarker test in the US.
