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. Author manuscript; available in PMC: 2020 Mar 6.
Published in final edited form as: Neuron. 2019 Mar 6;101(5):783–800. doi: 10.1016/j.neuron.2019.02.019

Table 1.

Biomarker Definitions with Present and Future Examples for Pain

Type of Biomarker Definition Pain Examples (present; future)
Diagnostic To detect or confirm the presence of a disease or condition. QST; EEG; intra-epidermal nerve fibre density;
microneurography; neuroimaging, Genetics
Monitoring To assess status of a disease or condition or effect of a medical product by any biomarker that is measured serially. QST; compound levels in plasma, CSF;
Neuroimaging; EEG; intra-epidermal nerve fibre density
Pharmacodynamic/Response To show that a biological response occurs in an individual exposed to a medical product. QST; neuroimaging; EEG; Changes in cytokines
Specific mechanistic/biochemical pain drivers; intra-epidermal nerve fibre density
Predictive To identify individuals more likely than individuals without the biomarker to experience a favourable or unfavourable effect from exposure to a medical product. Genetics
Neuroimaging; EEG; intra-epidermal nerve fibre density
Prognostic To identify likelihood of a clinical event, disease recurrence or progression in patients with disease of interest. Genetics
Neuroimaging; EEG; intra-epidermal nerve fibre density
Safety Measured before or after an exposure to a medical product to indicate likelihood, presence or extent of toxicity. Treatment related e.g. sedation, tolerance, constipation, respiratory depression
Neuroimaging; EEG
Susceptibility/Risk Potential for developing a disease or medical condition Genetics
Neuroimaging; EEG

Adapted from “BEST (Biomarkers, Endpoints, and other Tools) Resource”, a publication produced by the joint FDA-NIH Biomarker Working Group, December, 2016 (BEST, 2016)