Response to Comments for MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay

Medicare provides Coverage with Data Development for the Oncotype DX Prostate (GPS) assay for patients with NCCN very low- or low-risk prostate cancer being considered for active surveillance, provided the patient has an estimated life expectancy of at least 10 years and is enrolled in the contractor's registry/CTR with required data submission. Intermediate-risk patients are not covered under this policy pending prospective clinical utility studies, and unconditional coverage without registry participation is not granted.

"Coverage is provided for the Genomic Health Oncotype DX Prostate (GPS) assay for patients with NCCN very low-risk or low-risk prostate cancer being considered for active surveillance to aid risk st..."

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