First-of-Its-Kind, FDA-Cleared Test Uses Blood-Based Biomarkers To Assess Risk for Preeclampsia

ARUP Laboratories now offers an FDA-cleared test that will enable clinicians to assess a patient’s risk of developing preeclampsia with severe features. The preeclampsia risk assessment assay, one of the first of its kind to become available, measures the ratio between two angiogenic factors (soluble fms-like tyrosine kinase 1 [sFlt-1] and placental growth factor [PlGF]) that are produced by the placenta and, when out of balance, are associated with the development of preeclampsia. By providing a way to assess risk for preeclampsia and distinguish it from other hypertensive orders, this test will facilitate appropriate interventions, said Kelly Doyle, PhD, DABCC, FADLM, medical director of Special Chemistry and Endocrinology at ARUP.

“Research has specifically shown that if these markers are at a ratio above a certain threshold, the mother would be at high risk for progression to preeclampsia with severe features,” Doyle said. “If the ratio is below the threshold, there is a low risk of progressing to severe preeclampsia within two weeks.”

Although one of the clinical features of preeclampsia is hypertension, preeclampsia is a multisystem, progressive disorder that can lead to organ failure, seizure, stroke, and death. Preeclampsia remains one of the leading causes of maternal and infant mortality, resulting in more than 50,000 maternal deaths and 500,000 fetal deaths globally and affecting 2–8% of all pregnancies.

Doyle said preeclampsia can be difficult to differentiate from other hypertensive disorders, and this test represents a significant step forward in distinguishing preeclampsia. Current diagnostic testing for this condition includes multiple laboratory tests to determine organ function. However, these tests do not identify placental abnormalities, which play a key role in preeclampsia.

“When a woman does show signs of hypertension and may even show a slight elevation in protein in her urine, the clinician may opt to hospitalize as a precaution,” Doyle said. “Until now, clinicians didn’t have a tool to help them gauge the potential severity of the situation or help them determine the risk of progression toward preeclampsia with severe features.”

Heather Nelson, PhD, DABCC, medical director of Clinical Chemistry, noted that this risk assessment alone is not sufficient to make a diagnosis but will help facilitate treatment decisions.

“This test will complement other testing that is in use. … It will help the physician make [the] decision, ‘Do we need to deliver the baby?’” Nelson said. “This test provides a way for them to stratify the risk to both mother and the baby, whereas before, there wasn’t risk diversification.”

According to Doyle and Nelson, the only treatment for preeclampsia is to deliver the baby and placenta. The condition typically arises between 20 weeks of gestation and delivery, but can occur even after delivery.

This test is recommended for singleton pregnancies that are between 23 and 35 weeks of gestation.

“Predictive values are optimized for the ratio [of sFlt-1 and PlGF] and not the individual components,” Doyle said. “ARUP adheres to guidelines that suggest the ratio is the most useful element of testing.”

Doyle noted that testing for preeclampsia is a new area of research and there could be further developments.

“Research in this field is ongoing,” Doyle said. “While this is the first FDA-cleared test that has come to market, there is still potential for more yet to come.”

Kellie Carrigan, kellie.carrigan@aruplab.com