MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer

Coverage is allowed for germline hereditary cancer testing (including LDTs and NGS tests) only when the patient has a cancer diagnosis, a clinical indication and risk factors for inherited cancer, no prior testing of the same germline content, and the test has a satisfactory MolDX Technical Assessment with minimum guideline-supported genetic content. NGS tests must meet all NCD 90.2 conditions. Tests for polygenic risk scores, ctDNA, acquired (somatic) tumor testing, and tests without a satisfactory TA are excluded from coverage.

"Patient must have a cancer diagnosis, a documented clinical indication for germline (inherited) testing, a risk factor for inherited cancer, and must not have been previously tested for the same ge..."

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