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

Decipher® and other genomic assays validated as equivalent by MolDX are covered for men with localized or biochemically recurrent prostate adenocarcinoma and life expectancy >=10 years when results will inform guideline-directed treatment decisions (including active surveillance vs definitive therapy, decisions about radiation/ADT intensification, and post-prostatectomy radiotherapy decisions). Coverage requires an FFPE prostate biopsy specimen with >=0.5 mm linear tumor or a prostate resection specimen, no prior pelvic radiation or ADT before the specimen, and documentation that results will be used according to established practice guidelines.

"Male patients with localized (non-metastatic) or biochemically recurrent adenocarcinoma of the prostate are eligible for the Decipher® genomic classifier when they have a life expectancy >= 10 years."

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