MolDX: Breast Cancer Assay: Prosigna®

Prosigna testing is covered only for post‑menopausal women with ER‑positive invasive breast cancer who are either node‑negative with stage I–II disease or node‑positive with 1–3 positive nodes and stage II disease. Claims that do not meet these FDA‑specified indications (e.g., non‑post‑menopausal, ER‑negative, >3 positive nodes, or stage outside I–II) will be denied. Medical records should document ER status, nodal status/number, stage, and post‑menopausal status, and ideally the clinical intent to inform adjuvant therapy decisions.

"Post‑menopausal female with estrogen receptor positive (ER+) invasive breast cancer that is lymph node‑negative and stage I or II is eligible for Prosigna testing."

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