MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells

CTC-based biomarker assays are conditionally covered for patients with a cancer diagnosis when the biomarker is guideline-recommended and has demonstrated clinical utility in peer-reviewed literature, the test is performed on CTCs and has passed a MolDX Technical Assessment demonstrating AV/CV/CU, and at least one documented clinical justification for CTC testing is present (e.g., prior not-tested, newly metastatic untested lesion, progression, or treatment-resistance concern). Coverage also requires documented infeasibility or insufficiency of tissue testing when claimed; only one test per patient encounter is permitted unless a justified adjunct test meeting all criteria is necessary, and duplicate testing of the same biomarker from the same sample type for the same indication using different methodologies is not covered.

"Patient has a confirmed diagnosis of cancer."