MolDX: Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer

Non-NGS targeted molecular panel tests for predictive cancer testing are covered when the patient has cancer and tumor molecular testing will inform treatment, provided at least one condition is met (NGS infeasible/likely to fail, guidelines do not require NGS and non‑NGS yields rapid actionable results, or the test identifies necessary actionable biomarkers). Covered tests must detect genes/positions required for FDA companion-diagnostic therapies, be validated in the intended population and sample types, demonstrate accuracy comparable to NGS with turnaround under 10 business days, and complete a MolDX Technical Assessment with peer-reviewed evidence of clinical validity.

"Patient has a diagnosis of cancer for which molecular testing of the tumor will inform treatment decisions."

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