Qualifying a Biomarker through the Biomarker Qualification Program
- What is the FDA Biomarker Qualification Program (BQP)?
- What does the qualification of a biomarker mean?
- Are only newly developed biomarkers eligible for qualification?
- Does a biomarker have to be qualified to be used in drug development?
- If a biomarker has previously been used to support claims in drug labeling, does it mean that the biomarker is qualified?
- Does qualification of a biomarker also qualify the specific test performing the biomarker measurement?
- Can different assays, tests, or methods be used by drug sponsors when using a qualified biomarker in an IND/NDA/BLA?
What is the FDA Biomarker Qualification Program (BQP)?
FDA has established the BQP to work with external stakeholders to develop and qualify measurable and reliable biomarkers for a specific use in drug development. The BQP offers a formal process to guide requestors as they develop a biomarker so that the biomarker is: suited to a particular well defined COU; to ensure that biomarker measurement is feasible and reliable; and that the analytical performance adequately supports the context of use (COU).