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

MolDX covers gene expression profile tests for men actively managed for castration-resistant or metastatic prostate cancer when the patient is within the validated population, is a candidate for multiple management options or the test predicts response among accepted therapies, and has a life expectancy making them candidates for treatment per guidelines/FDA labeling. Coverage requires that the test demonstrate analytical validity, clinical validity (peer-reviewed), and clinical utility, be performed in a CLIA/FDA-compliant accredited lab, not duplicate prior testing, use a pre-treatment specimen (with a limited exception for those naïve to secondary systemic therapy), and successfully complete the MolDX Technical Assessment.

"Beneficiary is being actively managed for castration-resistant or metastatic prostate cancer (including hormone-sensitive or castration-resistant disease)."