MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer
L40209
Non-NGS targeted molecular panel tests are covered when the patient has cancer where tumor molecular testing will inform treatment and either NGS is infeasible or NGS is not required by guidelines and a rapid non-NGS result will inform prompt management. Coverage requires that the test detect the common actionable biomarkers (including genes/genomic positions tied to FDA-approved companion diagnostics), be validated in the intended population/sample types, demonstrate accuracy comparable to NGS with turnaround <10 business days, and have completed a MolDX Technical Assessment showing AV, CV, and CU. Tests previously performed for the same cancer indication and identical genetic content, tests lacking required validation/TA, or when NGS is required by consensus guidelines are not covered.
"Patient has a diagnosis of cancer for which molecular testing of the tumor will inform treatment."