First IPF Biomarker Clears Initial FDA Step Toward Qualification

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Dec 22, 2025, 11:24 ET

CHICAGO, Dec. 22, 2025 /PRNewswire/ -- The Prognostic Lung Fibrosis Consortium (PROLIFIC), a collaborative consortium advancing biomarker tools for pulmonary fibrosis (PF) research, announced today that the PROLIFIC Risk Score has been accepted into the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. The PROLIFIC Risk Score is the first and only idiopathic pulmonary fibrosis (IPF) biomarker to have been accepted into the CDER Biomarker Qualification Program.

Researchers are working to develop biomarker tools like the PROLIFIC Risk Score to support more efficient clinical trials and advance new treatments for idiopathic pulmonary fibrosis. PROLIFIC announced that the Risk Score has been accepted into the FDA CDER Biomarker Qualification Program, an early step toward potential qualification for use in drug development.

CDER's acceptance of PROLIFIC's Letter of Intent (LOI) is an important early milestone that allows the consortium to move forward in the FDA's review toward potential qualification for use in drug development. "This LOI acceptance signals that the FDA sees promise in our approach and the data behind it," said Peter Schafer, Chair of PROLIFIC. "It's the start of a longer process, and we're ready for the next stages."

Meeting an urgent need in IPF drug development

IPF is a life-threatening lung disease with no known cause. Over time, the lungs become scarred, making it harder to breathe. More than 250,000 Americans are living with IPF and other interstitial lung diseases (ILDs), and researchers are working urgently to bring better treatments to patients.

But the clinical trial process can be long and difficult. This is partially because today's tools, including breathing tests and basic patient characteristics, don't always reliably predict how someone's disease will progress. That uncertainty can make it harder to design trials and choose the right patient groups.

PROLIFIC's goal is to provide a biomarker-based tool that can help researchers identify and group patients for clinical trials, supporting more efficient trials and helping advance new therapies faster.

"For people living with IPF, the disease can behave very differently from one person to the next," said Amy Hajari Case, Chief Medical Officer of the Pulmonary Fibrosis Foundation. "Tools like the PROLIFIC Risk Score could help researchers make better risk assessments and design more efficient clinical trials."

Initial scope: IPF with a multi-biomarker panel built on biologic pathways

The current submission is focused on IPF, because the PROLIFIC Risk Score was built and tested using outcomes data from IPF populations, including data from the PFF Patient Registry and clinical trial datasets.

The Risk Score is a measure of a patient's prognosis, a prediction of the likely future course of disease, specifically transplant-free survival and lung function after one year. The score is based on a panel of serum proteins that reflect key processes involved in IPF, including:

Lung cell (epithelial) injury
Scarring (fibrosis)
Inflammation

Looking ahead: expanding beyond IPF

PROLIFIC intends to expand this work beyond IPF by evaluating the Risk Score approach in other forms of ILD. As additional patient cohorts and datasets become available, the consortium plans to test how well the biomarkers perform in non-IPF populations and refine the tool as needed. This broader evaluation is intended to support future clinical trials across a wider range of ILDs, including conditions such as rheumatoid arthritis–associated ILD.

About PROLIFIC

The Prognostic Lung Fibrosis Consortium (PROLIFIC) brings together industry and nonprofit partners to develop biomarker tools for pulmonary fibrosis research and drug development. PROLIFIC is facilitated in part by the Pulmonary Fibrosis Foundation.

About the Pulmonary Fibrosis Foundation

The Pulmonary Fibrosis Foundation is committed to accelerating research, empowering our community, and transforming care so that everyone with pulmonary fibrosis can live a better life. Our ultimate goal is to find a cure for pulmonary fibrosis. The PFF has a four-star rating from Charity Navigator and is an accredited charity by the Better Business Bureau (BBB) Wise Giving Alliance. The Foundation has met all of the requirements of the National Health Council Standards of Excellence Certification Program® and has earned the Guidestar Platinum Seal of Transparency. For more information, visit pulmonaryfibrosis.org or call 844.TalkPFF (844.825.5733)

Contact: Dorothy Coyle, Pulmonary Fibrosis Foundation, 773-332-6201

SOURCE The Pulmonary Fibrosis Foundation