Application of BEST (Biomarkers EndpointS & other Tools) biomarker definitions in cGvHD∗
| Type of marker . | Definition . | Application in alloHSCT . |
|---|---|---|
| Diagnostic | A biomarker used to detect or confirm presence of disease or condition of interest or to identify individuals with a subtype of the disease. | At the onset of cGvHD or late aGvHD compared with time-matched control |
| Response | A biomarker used to show that a biological response has occurred in an individual who has been exposed to a medical product or an environmental agent. | Measured 4-8 wk after treatment initiation for cGvHD |
| Predictive | A biomarker 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 medical product or an environmental agent. | Measured at the onset of treatment of cGvHD |
| Prognostic | A biomarker used to identify likelihood of a clinical event, disease recurrence or progression in patients who have the disease or medical condition of interest. | Measured at the onset of treatment of cGvHD |
| Risk | A biomarker that indicates the potential for developing a disease or medical condition who does not currently have clinically apparent disease or the medical condition. | Measured before cGvHD has developed, eg, at engraftment |
| Type of marker . | Definition . | Application in alloHSCT . |
|---|---|---|
| Diagnostic | A biomarker used to detect or confirm presence of disease or condition of interest or to identify individuals with a subtype of the disease. | At the onset of cGvHD or late aGvHD compared with time-matched control |
| Response | A biomarker used to show that a biological response has occurred in an individual who has been exposed to a medical product or an environmental agent. | Measured 4-8 wk after treatment initiation for cGvHD |
| Predictive | A biomarker 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 medical product or an environmental agent. | Measured at the onset of treatment of cGvHD |
| Prognostic | A biomarker used to identify likelihood of a clinical event, disease recurrence or progression in patients who have the disease or medical condition of interest. | Measured at the onset of treatment of cGvHD |
| Risk | A biomarker that indicates the potential for developing a disease or medical condition who does not currently have clinically apparent disease or the medical condition. | Measured before cGvHD has developed, eg, at engraftment |
Definitions are based on the FDA-NIH Biomarker Working Group Resource224.