MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells

CTC-based biomarker assays are covered only when the patient has cancer and the cancer type has an associated biomarker with established clinical utility in peer-reviewed literature or guideline support, testing is appropriate for the clinical scenario (e.g., not previously tested, metastatic lesion not tested, progression, resistance concern), and the CTC test has completed the MolDX Technical Assessment demonstrating AV, CV, and CU with clinical validation equivalent or superior to tissue-based testing. Tissue testing must be infeasible or insufficient to justify CTC testing, documentation of reasons must be in the medical record, only one test is allowed per patient encounter (with limited adjunct exceptions), and duplicate testing of the same biomarker from the same sample type for the same indication using different methods is not covered.

"Patient has a diagnosis of cancer."