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  6. Qualifying a Biomarker through the Biomarker Qualification Program
  1. Biomarker Qualification Program

Qualifying a Biomarker through the Biomarker Qualification Program

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).

Making Biomarker Development Successful


What does the qualification of a biomarker mean?

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.

What Does Biomarker Qualification Do (And Not Do)?


Transcript | Slides (PDF - 887KB)


Are only newly developed biomarkers eligible for qualification?

No, FDA will consider qualification of both novel and existing biomarkers, as appropriate.

Does a biomarker have to be qualified to be used in drug development?

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.

Watch Pathways for Using Biomarkers in Drug Development.

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

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov


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