FNIH Biomarkers Consortium Launches Project Seeking Regulatory Qualification of Biomarkers for Measuring Knee Osteoarthritis
August 2, 2018 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) has launched a project, under its Inflammation and Immunity Steering Committee, to seek regulatory qualification of new biological markers (biomarkers) that predict the change in joint damage over time from osteoarthritis (OA) in the knee. The PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers project, managed by the FNIH, will submit a comprehensive report, including imaging (i.e., MRI) and biochemical (i.e., urine, serum) biomarkers, for review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Biomarker qualification is the result of a formal regulatory process that affirms a biomarker can be relied upon to have a specific interpretation and used in the review of a potential drug. The acceptance of these biomarkers for use in drug development will pave the way for improved clinical trials and treatments for knee OA.
Considered the most common disorder of the joints, OA is a major cause of disability in older adults. A lack of tools to predict and monitor OA progression makes it difficult to evaluate current therapies and to develop new treatments. PROGRESS OA will lend a solution to this challenge by verifying a new set of biomarkers for patients with knee OA that were identified and validated by the previous FNIH OA Biomarkers Consortium Project. Specifically, the imaging biomarkers measure structural changes in the knee of OA patients, while the biochemical markers provide details about the cause of joint damage. The previous project has shown that a combination of these biomarkers more precisely predict and monitor changes in the knee compared to the current standard that uses only x-ray images.
The project team includes the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), leading academic experts in the field of OA, industry partners and the Arthritis Foundation. For more information about the project, click here.
- Arthritis Foundation*
- Duke University
- Kolon TissueGene*
- Merck KGaA*
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Pfizer/Eli Lilly and Company*
- University of Sydney
* indicates a funding partner