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Hirsch, FR et al. J Thorac Oncol 2016
Scenario
PD-L1 assay
Definition of
treatment
Clinical outcome
of test
Risk for
patient
A
Assay validated
for drug in trial
Definition validated in
trial for drug selection
Predictable based
upon trial data
Known
B
Assay trial-
validated assay
Definition validated in
trial for drug selection
Indirect data based
on comparative
studies
Not known
C
Any trial-
validated assay
Definition validated
with the assay
Uncertain
Not known
D
LDT using any
clone
Unknown
Very uncertain
Not known
Clinical scenarios for PD-L1
testing