The report is not a prescription

A whole-blood pharmacogenomics specimen arrives with two identifiers verified at collection and accessioning. The order is for CYP2D6 targeted genotyping with copy-number analysis, and the result becomes a defensible report only through a documented path from assay signal to interpretation. Written identity and integrity procedures must carry the specimen through reporting under 42 CFR 493.1232.

The result starts as a detected variant, not as a medication decision. A star allele and diplotype translate the assay signal into a predicted metabolizer phenotype. A gene-drug recommendation is a separate layer drawn from current guidance or labeling and requires qualified clinical interpretation.

CPIC guidance explains how to use an existing genotype result; it does not mandate testing. FDA labeling can contain pharmacogenomic information, but listing alone does not mandate a prescribing action. Release the measured result and its bounds, not an independent therapy choice.