MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers

Gene expression profile tests (non-NGS CGP and non-single-biomarker) are covered for men with established castration-resistant or metastatic prostate cancer who are actively managed and who fall within the validated population for the test. Coverage requires that the patient is a candidate for multiple management options or the test predicts response per guidelines/FDA, the specimen is pre-ADT/pelvic radiation (with a narrow exception), the test demonstrates AV/CV/CU with peer‑reviewed clinical validity and independent algorithm validation, is performed in a CLIA/FDA-accredited lab, and has completed a MolDX Technical Assessment (or demonstrates equivalent validity).

"Beneficiary is a man with an established diagnosis of castration-resistant or metastatic prostate cancer who is being actively managed for the condition."

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