MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy

MolDX will cover molecular tests for risk stratification of indeterminate pulmonary nodules only when all criteria are met: a non-diagnostic bronchoscopy for an IPN, inability or unwillingness to pursue alternate diagnostic procedures prior to results, the patient is in the intended-use population (not prior or current lung cancer and not overall low or high risk), and the test has demonstrated analytical and clinical validity/utility (including peer-reviewed evidence) and completes MolDX technical assessment. Tests relying on unvalidated algorithms, lacking evidence, previously performed for the same indication, or NGS on malignant samples are excluded. Required documentation includes non-diagnostic bronchoscopy/pathology reports, clinical justification for not using alternate diagnostics, evidence the test will inform management per consensus guidelines, prior-test history, peer-reviewed validation, algorithm validation, and MolDX assessment completion.