MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease

Decipher® (and other genomic assays with equivalent analytical and clinical validity per MolDX assessment) is covered for men with localized or biochemically recurrent prostate adenocarcinoma without clinical metastasis and with life expectancy >=10 years when the result will inform predefined treatment decisions (e.g., active surveillance vs definitive therapy, radiation treatment intensification, adjuvant or salvage radiotherapy decisions). Coverage requires testing on FFPE prostate biopsy tissue with ≥0.5 mm linear tumor or on prostate resection specimen, documentation that the patient has not received prior pelvic radiation or ADT for the indexed specimen, that the result will be used per established guidelines, and that the patient will be monitored per standard of care.

"Men with localized or biochemically recurrent prostate adenocarcinoma (no clinical evidence of metastasis) and a life expectancy >= 10 years may be tested when they are candidates for and are consi..."