MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
L39007
Limited coverage is provided for molecular DNA/RNA biomarker tests to risk-stratify men at increased risk for prostate cancer when all criteria are met: no established prostate cancer diagnosis, candidate for biopsy per consensus guidelines, PSA thresholds (men ≤75: PSA>3 ng/mL; men >75: PSA≥4 ng/mL), prior negative or non-malignant biopsy findings or no prior biopsy, and documented clinical utility and validation in the intended population. Tests must be performed in CLIA/FDA-accredited labs, ordered by a prostate specialist (with limited geographic exceptions), use independently validated algorithms, and only one biomarker per clinical indication is allowed unless a second is justified as an adjunct.
"Patient must NOT have an established diagnosis of prostate cancer to be eligible for a molecular biomarker test to risk-stratify for prostate cancer."
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