MolDX: Plasma-Based Genomic Profiling in Solid Tumors
L39230
Plasma-based NGS (liquid biopsy) using Guardant360 is covered for patients with recurrent/relapsed/refractory/metastatic or advanced non‑CNS solid tumors when the patient has not previously had Guardant360 testing for the same genetic content, is untreated or not responding to therapy, and is a candidate for FDA‑approved or NCCN‑recommended biomarker‑directed treatment. Coverage requires that the treatment decision is based on biomarkers included in the assay and that tissue‑based CGP is infeasible or, in NSCLC, tissue CGP showed no actionable mutations; repeat Guardant360 testing for the same content is restricted unless there is documented tumor evolution. Other plasma-based assays may be covered if they demonstrate performance comparable to Guardant360.
"Patient has a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system."