Table 1. Definitions and Terms
Molecular biomarker A biological molecule found in blood, body fluid or tissue that
provides information regarding presence or absence of a disease,
prognosis, or likelihood to respond to a specific treatment.
Molecular biomarkers broadly encompass DNA, transcriptome,
protein, metabolic, and other tissue-based or cellular biomarkers
Cellular biomarker Cells found in blood, body fluid or tissue that provide information
regarding presence or absence of a disease, prognosis, or likelihood
to respond to a specific treatment
Genomic biomarker Genetic material (including DNA or RNA) found in blood,
body fluid or tissue that provides information regarding presence
or absence of a disease, prognosis, or likelihood to respond to a
specific treatment
Active surveillance Monitoring prostate cancer rather than immediately treating it
Clinically significant
prostate cancer
Various definitions: in general, clinical, pathologic, or biomarker
features of prostate cancer suggesting a possibility of becoming
clinically relevant (symptoms or metastases)
Low-risk prostate
cancer
Gleason score ≤6 (Grade group 1), PSA <10 ng/ml, and non-
palpable or only palpable in less than half of one lobe of the
prostate (clinical stage T1c or T2a)
Intermediate-risk
prostate cancer
PSA 10-20 ng/ml, a clinical stage of T2b-T2c, or a Gleason score 7
(Grade group 2-3) grade without meeting any criteria for high-risk
High-risk prostate
cancer
Clinical stage T3a, Gleason score ≥8 (Grade group ≥4), or PSA
≥20 ng/ml
Very high-risk
prostate cancer
Clinical stage T3b-T4, any primary Gleason pattern 5 (Grade
group 5) or >4 cores of Gleason score 8-10 (Grade group ≥4)
Assay validity Comprehensive experiments that evaluate and document the quan-
titative performance of an assay, including sensitivity, specificity,
accuracy, precision, reproducibility, detection limit, range and
limits of quantitation.
Analytic validity How well a test predicts the presence or absence of a particular
disease, condition, or state
Clinical validity How well the test result is related to the presence, absence, or risk
of a specific disease
