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

Rhea-AI Summary

Labcorp (NYSE: LH) announced the launch of its first trimester preeclampsia screening test, available for all pregnant individuals between 11 and 14 weeks of gestation to assess the risk of developing preeclampsia before 34 weeks. This test utilizes four early pregnancy biomarkers and boasts a sensitivity of up to 90%, making it more effective than traditional risk assessment methods. Labcorp is now the only laboratory offering preeclampsia risk screening across all pregnancy trimesters in the U.S. This new test builds on Labcorp's previous launches, including an FDA-cleared blood test for severe preeclampsia in later stages of pregnancy.

Positive

• Launch of the first trimester preeclampsia screening test with up to 90% sensitivity.
• Labcorp becomes the sole lab offering preeclampsia risk screening across all pregnancy trimesters.
• Test availability for all pregnant individuals, including those with low- to average-risk and first-time pregnancies.
• Utilization of four key biomarkers for a comprehensive risk assessment.
• Endorsement by the Preeclampsia Foundation CEO.
• Test based on published data from SPREE and ASPRE studies, validating its efficacy.
• Support for women’s health through Labcorp's digital health platform, Ovia Health.
• Expanded portfolio in innovative diagnostic and screening solutions.

Negative

• Potential market competition if other labs develop similar tests.
• High development and marketing costs for newly launched tests.
• The focus on preeclampsia might overshadow other essential maternal health areas.

Insights

Medical Research Analyst

Labcorp's introduction of a first trimester preeclampsia screening test is a significant development in the field of maternal health. Preeclampsia is a major cause of maternal morbidity and mortality and early detection can lead to better clinical outcomes. The ability to screen for preeclampsia risk across all trimesters using a comprehensive set of biomarkers sets a new standard in prenatal care.

One key insight is the use of four early pregnancy biomarkers - PlGF, PAPP-A, MAP and UtAPI. This multimarker approach significantly enhances the sensitivity of risk assessment, with up to 90% sensitivity. For context, sensitivity measures the test's ability to correctly identify those with the condition, making this a robust tool for early intervention.

The SPREE and ASPRE studies provide strong validation for these biomarkers, suggesting that Labcorp's test is grounded in solid research. The combination of maternal factors with biochemical and biophysical markers offers a nuanced, evidence-based approach to risk assessment, likely to be well-received by healthcare providers.

A potential drawback, however, could be cost and accessibility. Advanced diagnostic tests may not be affordable for all populations and disparities in healthcare access might limit the benefits for some groups. Investors should monitor how Labcorp addresses these challenges, as broader accessibility could drive wider adoption of the test.

Financial Analyst

From a financial perspective, Labcorp's launch of the first trimester preeclampsia screening test appears promising. The uniqueness of the test in the U.S. market positions Labcorp as a leader in prenatal diagnostics, potentially driving significant revenue growth. Additionally, the test's high sensitivity could attract a wide range of healthcare providers, boosting demand.

It's important to consider the potential market size. Roughly 4% of pregnancies in the U.S. are affected by preeclampsia, which means the test could address a substantial segment of the prenatal care market. Furthermore, expanding offerings across all trimesters enriches Labcorp's product portfolio, enhancing its competitive advantage.

However, investors should also be aware of potential hurdles. The cost of the test and insurance coverage could influence its adoption rate. If Labcorp can secure broad insurance coverage, it will likely enhance market penetration. Monitoring the company's strategies in making the test accessible and affordable will be key to assessing its financial impact.

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

FAQ

What is Labcorp's new first trimester preeclampsia screening test?

Labcorp's new test assesses the risk of developing preeclampsia before 34 weeks, using four biomarkers and offering up to 90% sensitivity.

When is the Labcorp first trimester preeclampsia test performed?

The test is performed between 11 and 14 weeks of gestation.

Why is Labcorp's first trimester preeclampsia test significant?

It is the only test in the U.S. that can assess preeclampsia risk in the first trimester, providing early and comprehensive risk assessment.

How sensitive is Labcorp's new preeclampsia test?

The test has up to 90% sensitivity, nearly double that of traditional maternal history or biophysical factors alone.

What biomarkers does Labcorp's first trimester preeclampsia test measure?

The test measures placental growth factor (PlGF), pregnancy-associated plasma protein-A (PAPP-A), mean arterial pressure (MAP), and uterine artery pulsatility index (UtAPI).

What studies support the effectiveness of Labcorp's new preeclampsia test?

The test is based on data from the SPREE and ASPRE studies, which validated the use of its four biomarkers for early screening.

How does Labcorp's first trimester preeclampsia test benefit pregnant women?

The test offers earlier risk identification than traditional symptoms, helping healthcare providers improve prenatal care and outcomes for mothers and babies.