MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

MolDX covers molecular diagnostic classifiers for bladder cancer when the patient is actively managed, the test is intended for the patient's indicated population, and at least one of two clinical decision contexts is present (choice among multiple treatment intensities or prediction of therapy response supported by NCCN/ASCO/SUO/AUA). Tests must demonstrate analytical and clinical validation, independent algorithm validation if applicable, clinical validity and utility, complete the MolDX technical assessment, and NGS tests must meet NCD 90.2; only one pre-therapy test is allowed unless a second test interrogates different genomic content and meets all criteria.

"The beneficiary is being actively managed for bladder cancer at the time of testing."

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