MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers
L39686
Gene expression profile tests are covered for men with established castration‑resistant or metastatic prostate cancer who are actively managed and are candidates for multiple management options or when the test predicts therapy response per nationally recognized guidelines or FDA labeling. Coverage requires that the test be validated (AV, CV, CU) with peer‑reviewed clinical validity and independent algorithm validation, be performed in a CLIA/FDA‑regulated laboratory, and successfully complete a MolDX Technical Assessment; targeted/NGS CGP and single biomarker analyses are excluded. Tests performed on specimens obtained after pelvic radiation or ADT are generally not covered except for a narrow exception for men naïve to secondary systemic therapies meeting additional criteria.
"Gene expression profile testing is covered for men with an established diagnosis of castration‑resistant or metastatic prostate cancer who are candidates for prostate cancer treatment according to ..."