Level of evidence Basis for classification Tissue context Description of classification
m1A Clinical data Same histopathologic entity The biomarker’s predictive value or the drug’s clinical effectiveness was shown in a study or analysis of a molecularly stratified cohort with the same type of tumor.
m1B Clinical data Same histopathologic entity The biomarker’s predictive value or the drug’s clinical effectiveness was proven in a retrospective cohort or case–control study of molecularly stratified patients with the same tumor type.
m1C Clinical data Same histopathologic entity A case study or single unusual responder indicates that the biomarker is associated with response to the corresponding drug in the same tumor type.
m2A Clinical data Different histopathologic entity The predictive value of the biomarker or clinical effectiveness of the corresponding drug in a molecularly stratified cohort was demonstrated in a prospective study or meta-analysis in a different tumor type.
m2B Clinical data Different histopathologic entity The predictive value of the biomarker or clinical effectiveness of the drug in a molecularly stratified cohort was demonstrated in a retrospective cohort or case–control study in a different tumor type.
m2C Clinical data Different histopathologic entity A case study or single unusual responder indicates that the biomarker is associated with response to the corresponding drug in a different tumor type.
m3 Preclinical data Not applicable Preclinical data demonstrate that the biomarker predicts response to a specific drug, supported by a scientific rationale.
m4 Biological rationale Not applicable A biological rationale exists that associates the biomarker with altered activity of cellular pathways/processes or drug sensitivity without direct clinical or preclinical evidence for a response to the drug.