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

MolDX covers lab-developed, FDA-cleared, and FDA-approved hereditary germline cancer tests when all criteria are met: a cancer diagnosis, a clinical indication for germline testing, documented risk factors for inherited cancer, no prior testing of the same genetic content, and a satisfactory MolDX Technical Assessment. NGS tests must also meet NCD 90.2 requirements; tests lacking a TA, duplicative tests for the same genetic content, tests replaceable by targeted variant-specific assays, and somatic/ctDNA/acquired-cancer tests are excluded from coverage.

"Patient has any cancer diagnosis."

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