Qualification of cardiac troponins for nonclinical use: A regulatory perspective

- Discussion of first successful use of published research for biomarker qualification.
- The cardiac troponins submission and proposed context of use are summarized.
- Presentation of regulatory view of preanalytical and study design factors.
- Presentation of regulatory view of analytical validation.
- Discussion of issues to aid future submissions.

The US Food and Drug Administration (FDA) Biomarker Qualification Review Team presents its perspective on the recent qualification of cardiac troponins for use in nonclinical safety assessment studies. The goal of this manuscript is to provide greater transparency into the qualification process and factors that were considered in reaching a regulatory decision. This manuscript includes an overview of the data that were submitted and a discussion of the strengths and shortcomings of these data supporting the qualification decision. The cardiac troponin submission is the first literature-based biomarker application to be reviewed by the FDA and insights gained from this experience may aid future submissions and help streamline the characterization and qualification of future biomarkers.