Preeclampsia is a complication of pregnancy that affects approximately 5% of women worldwide. Clinically, preeclampsia may vary from mild to severe forms and may lead to premature delivery or other serious outcomes, which makes early detection and intervention paramount to successful treatment.
This serum test (Mayo ID: PERA) is the first preeclampsia-specific test that can be used to stratify patients into low or high-risk categories, indicating whether a patient is at risk for developing preeclampsia with severe features. With this information, clinicians can make more informed decisions about hospitalization, monitoring, more frequent checkups, and even early delivery.
1 in 25
1 in 25 pregnancies in the U.S. are affected by preeclampsia1
$7.5 billion of the $18.7 billion in medical costs associated with maternal morbidity can be attributed to hypertensive disorders during pregnancy2
The incidence of preeclampsia has nearly doubled in the U.S. from 2007 to 2019 and has been accelerating since 20143
Preeclampsia Test menu
Although the cause of preeclampsia remains unclear, the syndrome may be initiated by an imbalance of placental factors that induce endothelial dysfunction. sFlt-1 (soluble fms-like tyrosine kinase 1) and PIGF (placental growth factor) are both associated with placental dysfunction and risk of PE during pregnancy. Women with PE have been reported to have increased circulating concentrations of soluble fms-like tyrosine kinase 1 (sFlt-1), an antiangiogenic protein largely produced in the placenta, which is associated with inhibition of vascular endothelial growth factor and placental growth factor (PlGF). During pregnancy, PlGF concentrations typically increase progressively in the first and second trimesters and then decrease toward full term. In contrast, in cases of clinical preeclampsia, sFlt-1 concentrations are significantly increased versus concentrations observed in normal pregnancies, while concentrations of circulating free PlGF are significantly decreased relative to normal pregnancy.
The use of the sFlt-1/PIGF ratio has been shown to be a useful tool to aid in risk assessment of patients with clinical signs and symptoms consistent with the development of preeclampsia with severe features (as defined by the American College of Obstetricians and Gynecologists [ACOG, 2020] guidelines). Based on the data collected during the PRAECIS clinical study, the prognostic performance of the sFlt-1/PIGF ratio using a ratio cutoff of 40 (where if the ratio is greater than or equal to 40, there is a high risk for progression to preeclampsia with severe features), exhibited a sensitivity of 94% and specificity of 75% for the development of PE with severe features within two weeks. The performance of the sFlt-1/PlGF ratio to predict the development of PE with severe features within two weeks was statistically higher than the prognostic performance of other commonly used clinical (highest systolic blood pressure (SBP), highest Diastolic blood pressure (DBP) and laboratory general markers associated with preeclampsia such as AST, ALT, creatinine, and platelets).
New targeted prognostic assays for preeclampsia risk assessment are an important first step toward improving overall maternal health. The comprehensive clinical research behind the new test sets the stage for the use of more biomarkers to assess patient risk, inform care decisions, and improve maternal and fetal outcomes globally.
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