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?
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).
Qualification of a biomarker means that within a stated COU, the biomarker has been demonstrated to reliably support a specified manner of interpretation and application in drug development. Once qualified, the biomarker information is made publicly available and may be used in multiple drug development programs under its qualified COU.
No, FDA will consider qualification of both novel and existing biomarkers, as appropriate.
No. A biomarker does not have to be qualified to be used in drug development. Biomarker data for any biomarker can be reviewed and the biomarker accepted in the context of a specific candidate drug application.
If a biomarker has previously been used to support claims in drug labeling, does it mean that the biomarker is qualified?
No. Only biomarkers that have been reviewed and obtained qualification through the FDA BQP are considered qualified. Biomarkers that have not been formally qualified by the BQP may still be acceptable for use in drug development and support labeling claims through the FDA Drug Approval Process.
Does qualification of a biomarker also qualify the specific test performing the biomarker measurement?
No. Biomarkers being considered for qualification are independent of the specific test used to perform the measurement. However, a biomarker cannot be qualified without a reliable means to measure it. Therefore, the preanalytical considerations and the performance characteristics of the test(s) used to provide the `biomarker data will be considered throughout the qualification process, particularly during the Letter of Intent (LOI) and Qualification Plan (QP) stages. FDA clearance or approval of a testing device for use in clinical practice does not imply that the biomarker it measures has been demonstrated to have a qualified use in drug development. Additionally, qualification of a biomarker does not imply that a specific test device used in the qualification process for the biomarker has been reviewed by FDA and cleared or approved for use in patient care.
Can different assays, tests, or methods be used by drug sponsors when using a qualified biomarker in an IND/NDA/BLA?
Yes. Any analytically validated assay, test, or method may be used to measure a qualified biomarker in an IND/NDA/BLA submission, as long as the performance characteristics of the assay, test, or method demonstrate they can reliably and accurately measure the specific biomarker in a similar manner as the biomarker measurement method used for the biomarker’s qualification.
Important Information for Requestors
- Resources for Biomarker Requestors
- More About Biomarkers & Qualification
- General Biomarker Information
- 21st Century Cures Act
- Context of Use (COU)
- Biomarker FAQs
- BEST—a biomarker glossary
- Biomarker Qualification Submissions
- List of Qualified Biomarkers
- Letter of Support
Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov