MolDX: Plasma-Based Genomic Profiling in Solid Tumors
L38043
Plasma-based NGS (liquid biopsy) testing such as Guardant360® is covered for patients with recurrent/relapsed/refractory/metastatic/advanced solid tumors not originating in the CNS when tissue CGP is infeasible or (for NSCLC) tissue CGP shows no actionable mutations, the patient is untreated or not responding and is a candidate for FDA-approved or NCCN 1/2A biomarker-directed therapy. Repeat Guardant360® testing for the same genetic content is not covered unless clinical evidence of tumor evolution justifies testing for different genetic content; if ctDNA is insufficient or no alteration is detected, tissue-based genotyping should be considered. Other liquid assays may be covered only if they demonstrate similar performance to Guardant360® in their intended-use applications.
"Patient has a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system."