Concert Genetic Oncology: Circulating Tumor Cells (Liquid Biopsy)

This policy covers noninvasive liquid biopsy testing—circulating tumor DNA (ctDNA/cfDNA) and circulating tumor cell (CTC) assays—for molecular profiling to detect actionable/acquired mutations and to monitor tumor dynamics using specified commercial tests in patients with solid tumors (including specified lung, colorectal, breast, melanoma, prostate cancers and other malignancies). Major limitations: ctDNA may not replace histologic tissue diagnosis (negative ctDNA should prompt tissue-based testing), simultaneous ctDNA/tissue testing is generally limited to lung cancer, many broad ctDNA panels and specific gene tests are investigational or only covered for defined advanced/metastatic indications, and CTC assays are primarily prognostic rather than guides for therapy.

"Noninvasive testing of circulating tumor DNA (ctDNA/cfDNA) as an alternative to tissue biopsy for detection of actionable/driver or acquired genetic mutations that may guide targeted therapy."