First IPF Biomarker Clears Initial FDA Step Toward Qualification

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.