MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis

Molecular testing for hereditary transthyretin amyloidosis (hATTR) is covered when the patient has a clinical diagnosis of ATTR, or has cardiac or progressive neuropathic features suggestive of hATTR combined with supportive factors (African ancestry, a first‑degree relative with hATTR, or additional guideline‑recommended features). Coverage requires that the patient was offered genetic counseling, that results will inform treatment decisions, and that the test includes guideline‑validated genetic content and has completed a laboratory technical assessment (TA); single‑variant testing is allowed only for known familial pathogenic variants. Tests including unvalidated additional genetic content or lacking the required TA or minimum validated content are not covered.

"Patient has a clinical diagnosis of ATTR (transthyretin amyloidosis)."

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