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

Coverage is allowed for molecular testing to evaluate or manage suspected hereditary transthyretin amyloidosis (hATTR) when the patient has a clinical diagnosis of ATTR, or meets cardiac- or neuropathy-based clinical pathways combined with family history, ancestry, or other guideline-suggestive features. Tests must have pre-test counseling offered, be used to guide treatment decisions, include minimum guideline-based genetic content detectable by the assay, avoid unvalidated additional content, and have completed a supporting technical assessment; single-variant testing is permitted only for known familial variants.

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

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