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. |