Table 1.

Application of BEST (Biomarkers EndpointS & other Tools) biomarker definitions in cGvHD 

Type of markerDefinitionApplication 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 markerDefinitionApplication 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.

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