U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Biomarker Qualification Program
  6. What Does Biomarker Qualification Do (And Not Do)? Transcript
  1. Biomarker Qualification Program

What Does Biomarker Qualification Do (And Not Do)? Transcript

Hi. I’m Dr. Kylie Haskins with the FDA’s Center for Drug Evaluation and Research, also known as CDER. In this module, I’ll explain what biomarker qualification does, as well as some things that biomarker qualification does not do.

Biomarkers have long been used in drug development. One of the primary pathways through which biomarkers are accepted for use in drug development is through the drug approval process. In this pathway, the biomarker is included in the regulatory submission process for drug approval, such as in an IND, BLA, or NDA submission, and can gain acceptance for use in that specific drug development program.

Another pathway through which biomarkers are accepted for use in drug development is the Biomarker Qualification Program, which qualifies a biomarker for a particular context of use independent of a drug approval submission. This pathway is intended for biomarkers that will be used in multiple drug development programs.

CDER’s Biomarker Qualification Program was created to make biomarker data publicly available by establishing a biomarker’s value for a particular context of use in drug development and regulatory review. This means that, once qualified, a biomarker can be used in multiple drug development programs without the need for CDER to reconsider or reconfirm its suitability for that specific qualified context of use. When a biomarker is qualified, it means that the FDA accepts that the biomarker can be used to reliably support a specific context of use in drug development.

Let’s look at some of the implications of qualification. First, qualification means that there are data to support that the biomarker can provide information in drug development under its qualified context of use. Second, qualification means that there is evidence that the information provided by the biomarker provides a potential benefit of drug development. Third, biomarker qualification means that CDER accepts that the biomarker can be used in any drug development program under its qualified context of use. Fourth, CDER increases the public awareness of qualified biomarkers by providing all documentation necessary for their implementation. This includes a qualification guidance, an executive summary, and the review documentation, which contain an assessment of the data submitted for qualification, the conclusions that were drawn from the data, and information relevant to the use of the qualified biomarker for its specific context of use.

Something to keep in mind about biomarker qualification is that biomarkers considered for qualification are conceptually independent of the specific test that measures the biomarker. This means that qualification does not specifically endorse the test that is used to measure the biomarker. However, preanalytical considerations and the performance characteristics of the test used to provide the biomarker data need to support the biomarker’s context of use.

It’s important to understand the relationship between validation and biomarker qualification. Analytical validation and clinical validation are both necessary to support qualification of a biomarker, and both are specific to the biomarker’s context of use. Biomarker qualification does not imply approval or clearance of a diagnostic device or of a companion diagnostic device for use in clinical practice, and it also does not qualify the biomarker for use in clinical practice.

In this module, I covered several important points about what biomarker qualification does and how it can potentially contribute to drug development, as well as some information about what qualification does not do. When considering using biomarkers in drug development, consulting with FDA is a critical step to achieving success. Please visit CDER’s Biomarker Qualification Program website to learn more about biomarkers and access additional information

View more Videos and Podcasts on FDA’s Biomarker Qualification Program

Back to Top