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

Coverage is allowed for MolDX‑approved lab-developed tests, FDA-cleared, or FDA‑approved clinical laboratory tests for hereditary germline cancer testing when the patient has any cancer diagnosis, a clinical indication and risk factor for inherited cancer, has not previously been tested for the same germline content, and the test has completed a satisfactory MolDX Technical Assessment and (for NGS) meets NCD 90.2 requirements. Coverage is denied for tests without a completed TA, for tests duplicative of prior testing, for use to identify or confirm specific familial or somatic variants when a targeted test is available, and for excluded test types such as polygenic risk scores, ctDNA, and other somatic/acquired cancer tests.

"Patient has any cancer diagnosis."

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