The Foundation for the National Institutes of Health Launches First Public-Private Partnership for Early Detection of Preeclampsia

Project Addresses High Rate of Maternal Deaths in United States

NORTH BETHESDA, MD, February 12, 2024—The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia. The project is part of the FNIH Biomarkers Consortium and is a collaboration with the National Institutes of Health (NIH) and eight other partners representing life sciences companies, academia, and nonprofit and patient advocacy organizations.

Preeclampsia is a serious pregnancy-related hypertensive disorder that can lead to maternal and neonatal deaths and long-term negative health outcomes. The disorder is becoming more prevalent in the United States, with women of color more likely to be affected and experience poor outcomes. Identifying women earlier in pregnancy who are at heightened risk for the disorder would allow clinical intervention that could lead to a major improvement in outcomes, particularly for underserved communities that have been carrying the highest burden of preeclampsia.

“The alarming rise in maternal mortality in the United States is unacceptable, and preeclampsia is a leading cause,” said Julie Gerberding, MD, MPH, President and CEO of the FNIH. “It is imperative that we find solutions that will enable new research in maternal health and lead to better clinical care and better outcomes for all mothers-to-be.”

More than 70,000 women and 500,000 newborns die each year from preeclampsia worldwide. In the United States, preeclampsia can only be diagnosed clinically, often late in the process after organ damage has already occurred and premature delivery may be required. Currently, preeclampsia risk is determined early in pregnancy using a combination of maternal medical history and clinical risk factors.

This three-year project brings together key stakeholders in maternal and child health to 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.

“We play a key role in this public-private partnership by providing financial support and access to biosamples and data from our supported cohorts,” said Diana W. Bianchi, MD, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “This project is one example of how the NIH is working to create public-private partnerships as described in the recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).”

At the conclusion of the study, the project team will submit a letter of intent to the U.S. Food and Drug Administration (FDA) Biomarkers Qualification Program, an important step toward obtaining regulatory approval from the FDA for further use of these biomarkers. With FDA approval, the biomarkers may help identify pregnant individuals at risk for developing early-onset preeclampsia, and potentially inform decision-making about the use of therapeutic interventions and facilitate enrollment in clinical trials for future treatments.

“The FNIH project is the first public-private partnership in the United States to detect biomarkers of early-onset preeclampsia,” said Tania Kamphaus, MSc, PhD, FNIH’s Director of Metabolic Disorders. “These biomarkers have never been tested on populations reflective of the United States, despite their availability in Europe.”

This public-private partnership is supported by NICHD, the Bill & Melinda Gates Foundation, Merck for Mothers, Preeclampsia Foundation, Thermo Fisher Scientific, Revvity, Cedars-Sinai, The Ohio State University Wexner Medical Center, and the George Washington University.

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About Preeclampsia

A growing health problem in the United States, preeclampsia is a serious pregnancy-related hypertensive disorder and one of the leading causes of maternal and infant deaths. Due to existing health disparities in the U.S., women of color are more likely to develop preeclampsia and more likely to experience poor health outcomes.

In addition to the near-term risk to the mother and child, the disorder places both at increased risk for cardiovascular issues, hypertension, and type 2 diabetes over their lifetimes. Preeclampsia causes a substantial financial burden too, resulting in more than $2 billion in healthcare costs through the first year after delivery.

About the Biomarkers Consortium

The Foundation for the National Institutes of Health’s Biomarkers Consortium leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. The core operations of the Biomarkers Consortium are supported through its contributing membership program, which includes the National Institutes of Health, the U.S. Food and Drug Administration, private industry, and not-for-profit organizations.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit