Labcorp is now the only lab that can detect
preeclampsia risk across all pregnancy trimesters
BURLINGTON, N.C., May 15, 2024
/PRNewswire/ -- 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.
For more information about Labcorp's offerings across women's
health and its first trimester test, visit
https://womenshealth.labcorp.com/providers/pregnancy/preeclampsia-screening
About Labcorp
Labcorp (NYSE: LH) is a global
leader of innovative and comprehensive laboratory services that
helps doctors, hospitals, pharmaceutical companies, researchers and
patients make clear and confident decisions. We provide insights
and advance science to improve health and improve lives through our
unparalleled diagnostics and drug development laboratory
capabilities. The company's more than 67,000 employees serve
clients in approximately 100 countries, provided support for 84% of
the new drugs and therapeutic products approved in 2023 by the FDA,
and performed more than 600 million tests for patients around the
world. Learn more about us at www.labcorp.com.
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SOURCE Labcorp