FAQs
1. What is the typical process for a novel biomarker to move from discovery to clinical use?
The typical process involves three stages. It begins with discovery, which identifies potential biological candidates. This is followed by validation to test sensitivity in large cohorts, and consequently, the marker’s accuracy is confirmed. Ultimately, the process reaches qualification, thereby establishing clinical utility through the necessary regulatory approvals.
2. Are all biomarkers physical substances, or can clinical observations qualify?
No. A biomarker is any measurable indicator. While often molecular, it can also be a physiological or digital measurement. Examples include gait speed tracked by a sensor or a specific pattern of tissue change observed in imaging.
3. What does it mean for a biomarker to be “surrogate”?
A surrogate biomarker is an indicator used as a substitute for a definitive clinical endpoint, such as survival or irreversible progression. It is measured because it is easier, faster, or cheaper to assess in clinical trials.
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