• Biomarkers for Risk Stratification and Detection of Early-Onset Preeclampsia
Overview

Preeclampsia is a serious pregnancy-related hypertension condition, which can damage multiple organ systems in the mother leading to maternal and infant morbidity, mortality, and lifelong adverse health effects. Currently, in the United States, the disease can only be diagnosed clinically, however this is usually late in the process and often after organ damage has already occurred. Biomarkers that can detect preeclampsia early will enable interventions that can delay onset of preeclampsia, especially its most damaging form, early-onset preeclampsia. 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. This will optimize clinical benefit before preeclampsia develops and improve outcomes and long-term health of both mother and child.

Goals

  • Retrospectively assess data and biobank specimens collected during the first trimester. Develop algorithm/model to test biomarkers that are predicted to improve sensitivity and specificity. Submit LOI to FDA and publish project results

  • 1. 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

  • 2. 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

  • The Project Team will start planning a second (future) project for the potential submission of an FDA Qualification Plan and a possible prospective trial implementation

Partner with Us

The Foundation for the National Institutes of Health (FNIH) actively seeks private-sector participation in the Biomarkers for Risk Stratification and Detection of Early-Onset Preeclampsia Project. This project represents a generous commitment from the National Institute of Child Health and Human Development (NICHD) in the form of existing cohorts and datasets as well as from assay developers who are donating their products for evaluation. FNIH welcomes interested parties with diagnostic tools beyond PlGF and PAPP-A that might prove useful in predicting risk for early-onset preeclampsia and preeclampsia.

Full-funding partners may have up to two participants on the Project Team and may cast one vote on project decisions. Throughout the life of the project, the FNIH will work to ensure that all partners have ample opportunity to provide input and share valuable expertise. Active participation and broad acknowledgment of all private partners will be facilitated through:

  • Early data access and Project Scientific and Regulatory Insights
  • Participation on the Project Team and in regular Project Team teleconferences.
  • Progress reports provided by the Project PIs and one virtual/face-to-face meeting per year.
  • Collaboration with FNIH staff to ensure recognition in press releases and other print materials related to the project, in the FNIH annual report, on its website at fnih.org and by other means as appropriate.

Project Impact

Contact
Tania Kamphaus, MSc, PhD

Director, Translational Science
Metabolic Disorders and FNIH Director of Patient Engagement

[email protected]
Melissa Jones Reyes, PhD

Program Manager, Translational Science
Metabolic Disorders

[email protected]
Leah Singleton

Strategic Alliances Officer

[email protected]

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