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:
- Poon, L. et al. The International Federation of Gynecology and
Obstetrics (FIGO) initiative on pre-eclampsia. Int. J. Gynaecol.
Obstet. 145, 1 (2019).
- 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.
- Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic
factor levels in hypertensive disorders of pregnancy. NEJM Evid
2022; 1:EVIDoa2200161.
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SOURCE Labcorp