Molecular biomarkers for grass pollen immunotherapy

Table 1 General classification of molecular biomarkers[1-11]

Biomarkers	Definitions, comments
Disease-related genomic and proteomic biomarkers
Disease risk biomarkers	Biomarkers associated with the risk of a disease
Diagnostic biomarkers	Indicators of the presence of a disease in an individual, including molecular diagnosis, early disease detection and screening biomarkers
Disease staging biomarkers	Biomarkers for assessing disease severity
Disease prognostic biomarkers	Indicators of the likely course/outcome of a disease for an individual; originally defined as markers that indicate the likely natural course of a disease in an untreated individual, also used to define the baseline risk that suggest the likely outcome of a disease independent of treatment
Drug-related biomarkers (provide information about a patient’s response to a therapeutic intervention)
Pharmacogenomic biomarkers	Defining a DNA or RNA characteristic that is indicator of a response to a therapeutic intervention, facilitate the combination of therapeutics with diagnostics through pharmacogenetics (the study of genetic influence on drug response) and pharmacogenomics (the study of how genomic variation influences drug response)
Proof-of-mechanism biomarkers	Assess, in clinical trials, whether a drug has impacted its target
Drug activity biomarkers	Track the effect of a therapeutic intervention in accordance with its mechanism of action
Pharmacodynamic biomarkers	Measure the effect of a drug on the disease and determine the most effective dose for the patient, as efficacy biomarkers
Toxicity biomarkers	Determine the underlying susceptibility of a patient for a particular side effect or group of side effects
Surrogate biomarkers	Intended to substitute a clinical endpoint in clinical trials and expected to predict clinical benefit
Integral biomarkers	Used in clinical trials for eligibility, stratification, or treatment assignment
Integrated biomarkers	Intended to be used in clinical trials for hypothesis generation or testing, without impact on the treatment
Predictive biomarkers	Pretreatment or baseline measurements used to predict the patient response to a particular treatment