Table 1.
Biomarker definitions as per NIH BEST Resource 3
| Biomarker Subtype | Definition |
|---|---|
| Diagnostic | An assay used to confirm the presence of the disease |
| Predictive | An assay used to identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a specific medical product (before treatment is received) |
| Response | An assay used to show that a biological response has occurred in an individual who has been exposed to a medical product (after treatment is received) |
| Prognostic | An assay used to identify likelihood of a clinical event, disease recurrence or progression in patients who have the disease |
| Risk | An assay that indicates the potential for developing the disease in individuals who do not have clinically apparent disease |