Labcorp Launches New Test for Risk Assessment and Prognosis of Severe Preeclampsia in Pregnant Women

Rhea-AI Summary

Labcorp (LH) launches FDA-cleared sFlt-1/PlGF KRYPTOR test system to aid in risk assessment of severe preeclampsia, a leading cause of maternal and fetal mortality in the U.S. The test measures two angiogenic biomarkers and helps identify patients at risk of progressing to severe features of preeclampsia within two weeks of the test, leading to enhanced surveillance and accelerated care.

Medical Research Analyst

The introduction of the B•R•A•H•M•S™ sFlt-1/PlGF KRYPTOR™ Test System represents a significant advancement in the field of obstetric care, specifically in the detection and management of preeclampsia. This condition, characterized by high blood pressure and potential organ damage in pregnant women, has historically been challenging to predict and manage effectively. The test's ability to measure angiogenic biomarkers—sFlt-1 and PlGF—and provide a ratio indicative of preeclampsia risk is a breakthrough, as it leverages molecular insights to inform clinical decisions.

From a research perspective, the validation of this test through the PRAECIS study underscores its potential to reduce severe maternal and perinatal outcomes, which are critical issues in obstetrics. Furthermore, the test's recognition by TIME Magazine as one of the Best Inventions highlights its perceived impact on healthcare. The focus on a blood-based test for risk assessment aligns with the trend towards non-invasive, patient-friendly diagnostic methods that can deliver rapid and reliable results.

Healthcare Economist

The economic implications of the new FDA-cleared test are multifaceted. On one hand, the ability to provide early risk assessment for preeclampsia could lead to reduced healthcare costs associated with severe maternal and neonatal complications. By identifying at-risk pregnancies earlier, healthcare providers can implement targeted interventions, potentially decreasing the need for extensive neonatal care or complex maternal treatments that arise from unanticipated emergencies. On the other hand, widespread adoption of the test could increase upfront screening costs.

However, the long-term cost savings from preventing severe cases of preeclampsia could outweigh initial expenses. For insurers and healthcare systems, the test represents a preventive measure that aligns with value-based care models, which emphasize the quality of care and patient outcomes over the volume of services provided. As such, it could become an integral part of prenatal care protocols, influencing insurance coverage policies and healthcare spending in obstetrics.

Market Research Analyst

The launch of the B•R•A•H•M•S™ sFlt-1/PlGF KRYPTOR™ Test System by Labcorp, in partnership with Thermo Fisher Scientific, could have a notable impact on the laboratory diagnostic market. Labcorp's positioning as a global leader in laboratory services means that the test's availability could quickly become widespread, potentially creating a new standard of care for preeclampsia risk assessment.

Given the prevalence of preeclampsia in pregnancies and the test's potential to influence clinical management, demand is likely to grow. This could lead to increased revenue streams for both Labcorp and Thermo Fisher Scientific. Additionally, the test's potential to improve outcomes could enhance the reputation of these companies in the women's health diagnostics market, potentially leading to market share growth and increased investor confidence.

B•R•A•H•M•S™ sFlt-1/PlGF KRYPTOR™ Test System is available through physicians and is the first FDA-cleared biomarker test to aid in the risk assessment of progression to preeclampsia with severe features, a leading cause of maternal and fetal mortality in the U.S.¹

BURLINGTON, N.C., Jan. 31, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the launch and availability of a new, FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia, a life-threatening blood pressure disorder that occurs during pregnancy and the postpartum period.

Preeclampsia is a condition unique to pregnancy that affects 2-5% of all pregnancies and is a major cause of maternal and neonatal morbidity and mortality in the United States.¹ Standard approaches for clinical diagnosis of preeclampsia, such as blood pressure and proteinuria evaluation, have been shown to be inadequate predictors of severe adverse maternal and perinatal outcomes.²

The new test, developed by Thermo Fisher Scientific and named one of TIME Magazine's Best Inventions of 2023, measures two angiogenic biomarkers associated with preeclampsia, serum soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF).

The test result, a ratio of these two biomarkers, in conjunction with other laboratory tests and clinical assessments, helps clinicians identify which patients hospitalized for hypertensive disorders of pregnancy may be at risk of progressing to severe features of preeclampsia within the next two weeks of the test. This was validated by the PRAECIS study, which examined more than 1,000 pregnant women across 18 hospitals in the U.S.³

The blood-based test is intended for use in singleton pregnancies between 23+0 and 34+6/7 weeks gestation. Pregnant women who test positive based on the risk stratification sFlt-1/PlGF ratio ≥ 40, along with other indicators of disease, can receive enhanced surveillance and accelerated care before severe features develop.

"Labcorp is proud to partner with Thermo Fisher to offer this new test, which is used in the second and third trimester of pregnancy to assess patients hospitalized for hypertensive disorders and offers providers early and objective information to assist in the management of preeclampsia," said Marcia Eisenberg, Ph.D., Senior Vice President and Chief Scientific Officer at Labcorp. "In line with Labcorp's mission to improve health and improve lives, this offering is another example of our commitment to provide the most comprehensive and advanced menu of diagnostic tests, while supporting patients and providers with clinically important and meaningful information to support better outcomes for parents and their newborns."

For more information, visit https://womenshealth.labcorp.com/providers/pregnancy and click on the "second and third trimester tab."

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 60,000 employees serve clients in over 100 countries, worked on over 80% of the new drugs approved by the FDA in 2022 and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.

References:

1. Poon, L. et al. The International Federation of Gynecology and Obstetrics (FIGO) initiative on pre-eclampsia. Int. J. Gynaecol. Obstet. 145, 1 (2019).
2. Zhang J, Klebanoff MA, Roberts JM. Prediction of adverse outcomes by common definitions of hypertension in pregnancy. Obstet Gynecol. 2001 Feb;97(2):261-7. doi: 10.1016/s0029-7844(00)01125-x. PMID: 11165592.
3. Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022; 1:EVIDoa2200161.

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-new-test-for-risk-assessment-and-prognosis-of-severe-preeclampsia-in-pregnant-women-302049196.html

SOURCE Labcorp

FAQ

What is the purpose of Labcorp's sFlt-1/PlGF KRYPTOR test system?

The purpose of Labcorp's sFlt-1/PlGF KRYPTOR test system is to aid in the risk assessment of progression to severe preeclampsia, a leading cause of maternal and fetal mortality in the U.S.

What are the angiogenic biomarkers associated with preeclampsia measured by the test?

The test measures two angiogenic biomarkers associated with preeclampsia, serum soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF).

What is the significance of the sFlt-1/PlGF ratio in the test result?

The sFlt-1/PlGF ratio, in conjunction with other laboratory tests and clinical assessments, helps clinicians identify which patients hospitalized for hypertensive disorders of pregnancy may be at risk of progressing to severe features of preeclampsia within the next two weeks of the test.

What is the intended use of the blood-based test?

The blood-based test is intended for use in singleton pregnancies between 23+0 and 34+6/7 weeks gestation.

How can pregnant women benefit from the test results?

Pregnant women who test positive based on the risk stratification sFlt-1/PlGF ratio ≥ 40, along with other indicators of disease, can receive enhanced surveillance and accelerated care before severe features develop.