Biomarkers Consortium – Biomarkers for Risk Stratification and Detection of Early-Onset Preeclampsia

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Biomarkers Consortium – Biomarkers for Risk Stratification and Detection of Early-Onset Preeclampsia

Our mission is to improve the outcomes and long-term health of mothers and infants by identifying tools to predict the risk of early-onset preeclampsia.

Preeclampsia is a serious pregnancy-related hypertension condition, which can lead to maternal and infant morbidity, mortality, and lifelong adverse health effects. Currently, in the United States, the disease can only be diagnosed clinically, usually late in the process and often after organ damage has already occurred and premature delivery may be required.

Biomarkers that can detect preeclampsia early will enable interventions that can delay onset of preeclampsia, especially its most damaging form, early-onset preeclampsia. This three-year project will evaluate the predictive value of two circulating biomarkers—placental growth factor (PIGF) and pregnancy-associated plasma protein-A (PAPP-A)—during the first trimester of pregnancy. The project will use patient data and banked samples from more than 25,000 pregnancies representative of the ethnic and racial diversity found within the North American population. Qualified biomarkers resulting from this study will help identify pregnant individuals at high risk of developing early-onset preeclampsia, increasing the benefit of future and current therapeutic intervention and decreasing the regulatory burden for inclusion in clinical trials.

Goals

Test and advance toward FDA qualification of placental biomarkers (through in vitro diagnostic tests for PlGF and PAPP-A) for predicting risk during the first trimester for the development of early-onset preeclampsia.
Improve predictive power of in vitro diagnostic tests by developing an algorithm that includes additional measurements, including common clinical data, serum nucleic acids, and/or imaging data.
Submit a letter of intent to the FDA Biomarkers Qualification Program and publish project results.