Table 3.

Evaluation of Genomic Tests and Other Biomarkers

Assessment Level	Description
Analytic validity	A test's ability to accurately and reliably measure the molecular target of interest (genotype)
Clinical validity	A test's ability to detect or predict the associated disorder (phenotype), including clinical sensitivity (or the clinical detection rate), clinical specificity, and positive and negative predictive values
Clinical utility	A test's ability to affect clinical decisions and to improve patient outcomes in clinical practice

Adapted from the Centers for Disease Control's Office of Public Health Genomics.^14a