MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer
L40221
Non-NGS targeted molecular panel tests for predictive cancer testing are covered when the patient has cancer for which tumor molecular testing will inform treatment and either NGS is not feasible/likely to fail or NGS is not required by guidelines and a non-NGS test provides a more rapid, actionable result. Coverage also requires that the non-NGS test detects the necessary predictive biomarkers (including genes/genomic positions tied to FDA-approved companion diagnostics), has appropriate analytical and clinical validation (including MolDX Technical Assessment and peer-reviewed evidence), has comparable accuracy to NGS with turnaround under 10 business days, and that the patient has not previously received testing for the same indication and genetic content.
"Patient has a diagnosis of cancer for which molecular testing of the tumor will inform treatment decisions."