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Markers with strong performance data that have
successfully completed initial validation studies
in subsequent reports or in a multi-centre setting
with more than 120 patients.
Tier 2 – high-performing biomarkers
○
Markers with good performance data that have not
completed validation studies. Markers in this
category are further divided into subgroups
depending on the intended use and number of
patients.
▪
2A: Specificity and sensitivity
>80%, or specificity or
sensitivity >85%*, with an intended use of early
detection, prediction or differential diagnosis
and greater than 120 subjects
▪
2B: Specificity and sensitivity
>80%, or specificity or
sensitivity >85%*, with an intended use of early
detection, prediction or differential diagnosis
and less than 120 subjects
▪
2C: Specificity and sensitivity
>80%, or specificity or
sensitivity >85%*, with an intended use of
diagnosis
▪
2D: Same criteria as Tier 2A–C, with
markers having applications in both blood and
CSF.
Tier 3 – promising candidate biomarkers
○
Innovative markers with promising performance
data but have not yet produced higher performance
results in clinical settings.
*
Along with an adequate, non-zero score on the other
parameter