Performance of a novel multi-biomarker rule-out test for preeclampsia

A prospective verification study demonstrates that the Preecludia™ test has high sensitivity and high negative predictive value.

Preeclampsia complicates 2 – 8% of all pregnancies worldwide and is one of the leading causes of maternal and neonatal mortality.1 There is no definitive, diagnostic test for preeclampsia. Current tools, such as blood pressure readings and urine protein tests, measure the maternal clinical response of preeclampsia but are not directly linked to the underlying pathophysiology of the syndrome. Accurately assessing a low risk of developing preterm preeclampsia could potentially avoid unnecessary interventions and premature delivery.

The goal of this observational clinical verification study was to determine the performance of the Preecludia™ test to assess the risk for preeclampsia within 14 days of sample collection from women presenting with signs or symptoms of possible preeclampsia.2

What did we find?

  • In women with suspected preeclampsia at 28 to 36 6/7 weeks’ gestation, the Preecludia test has high sensitivity and high negative predictive value (NPV) to rule out the risk of developing preeclampsia within 14 days, up to 37 weeks’ gestation.
  • Test performance on 303 subjects showed 87.8% sensitivity and 97.0% NPV.
  • The population in the study was representative of the US population.

Poster

This research was presented at the virtual American College of Obstetricians and Gynecologists (ACOG) 2021 Annual Clinical and Scientific Meeting.

Download the poster

  1. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Gestational hypertension and preeclampsia. Number 222. Obstet Gynecol. 2020; 135(6):e237-e260.
  2. Cooper M, et al. Performance of a novel multi-biomarker rule-out preeclampsia test: a prospective verification study. Poster presented at the 2021 ACOG Annual Clinical and Scientific Meeting.

Support