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

Molecular testing for hereditary transthyretin amyloidosis (hATTR) is covered when patients have a clinical diagnosis of ATTR or present with cardiac or progressive neuropathic features plus supporting risk factors (African ancestry, a first‑degree relative with hATTR, or ≥1 additional guideline‑based suggestive feature). Covered tests must be used to guide treatment, have pre‑test counseling offered, include guideline‑supported genetic content detectable by the assay, be properly validated (including completion of the contractor technical assessment), and must not report unvalidated or clinically unclear genetic content; single‑variant testing is permitted only for known familial variants.

"Molecular testing is covered for patients with a clinical diagnosis of transthyretin amyloidosis (ATTR)."

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