The B•R•A•H•M•S sFlt-1/PlGF KRYPTOR test system is the first FDA-approved biomarker test that helps physicians in the risk assessment of progression to preeclampsia with severe features, a major cause of maternal and foetal mortality in the US
Labcorp’s new blood test helps predict severe preeclampsia. (Credit: Testalize.me on Unsplash)
US-based laboratory services provider Labcorp has rolled out a new, FDA-approved blood test for risk assessment and clinical management of severe preeclampsia in pregnant women.
Severe Preeclampsia is a life-threatening cardiovascular disorder that occurs during pregnancy and the postpartum period, affecting 2-5% of all pregnancies.
The standard approaches for clinical diagnosis of preeclampsia include blood pressure and proteinuria evaluation, which are inadequate to predict severe adverse outcomes.
The new test, dubbed B•R•A•H•M•S sFlt-1/PlGF Kryptor Test System, was originally developed by Thermo Fisher Scientific.
It 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, together with other tests and clinical assessments, helps clinicians identify patients who are at risk of severe preeclampsia.
The Kryptor Test System was validated by the PRAECIS study, which examined more than 1,000 pregnant women across 18 hospitals in the US.
The blood-based test is intended for use in singleton pregnancies aged between 23+0 and 34+6/7 weeks gestation period.
The pregnant women are considered as positive if the risk stratification sFlt-1/PlGF ratio is greater than 40, along with other indicators of disease.
Those who test positive can receive enhanced surveillance and advanced care before they develop severe features.
Labcorp senior vice president and chief scientific officer Marcia Eisenberg said: “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.
“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.”