Circulating Tumor DNA and Circulating Tumor Cells for Management (Liquid Biopsy) of Solid Tumor Cancers
Cell-free tumor DNA testing in blood for targeted treatment selection is considered medically necessary when either advanced or metastatic ER-positive, HER2-negative breast cancer is present, or when clinical documentation shows tissue-based testing cannot be performed and the test includes at least one gene with an FDA-approved targeted therapy for that cancer indication. Cell-free DNA testing for targeted treatment selection is investigational when those criteria are not met, including urine tests. Cell-free DNA and circulating tumor cell testing for all other solid tumor indications, including measurable residual disease testing and cancer screening in asymptomatic individuals, is considered investigational.