MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells

CTC-based biomarker assays are covered only for patients with a diagnosed cancer when the cancer and biomarker have established guideline-supported testing and the biomarker has demonstrated clinical utility in peer-reviewed literature. Coverage requires documented medical justification (no prior testing, newly metastatic lesion not tested, progression, or concern for resistance), technical feasibility from CTCs, MolDX Technical Assessment and published clinical validation equivalent or superior to tissue testing, and documented tissue infeasibility or insufficiency when applicable; duplicate testing and multiple tests per encounter are restricted.

"Patient has a confirmed diagnosis of cancer."

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