MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells

CTC-based biomarker assays are covered only for patients with a cancer diagnosis when the cancer type has an associated biomarker with established clinical utility in peer‑reviewed literature and one of specified clinical indications (e.g., not previously tested, newly metastatic lesion untested, progression, or concern for resistance). Coverage requires that the biomarker can be tested using CTCs, that the specific CTC-based test has passed MolDX Technical Assessment demonstrating AV/CV/CU with clinical validation equivalent or superior to tissue-based testing, and that tissue-based testing is infeasible or insufficient when applicable. Only one test per patient encounter is allowed unless a second adjunct test meeting all criteria is reasonable and duplicate testing of the same biomarker from the same sample type for the same indication using different methods is excluded.

"Patient has a documented cancer diagnosis."