MolDX: Breast Cancer Assay: Prosigna®

Prosigna® testing is covered only for post‑menopausal females with estrogen receptor positive (ER+) early breast cancer who are either node‑negative (stage I–II) or have 1–3 positive nodes (stage II) consistent with FDA indications. Claims for testing that do not meet all of these FDA‑specified criteria will be denied; documentation should support menopausal status, ER status, tumor stage, and node status, and reports are issued separately for node‑negative and node‑positive populations.

"Post‑menopausal female with estrogen receptor positive (ER+) breast cancer that is lymph node‑negative (0 positive nodes) and clinical stage I or II is eligible for Prosigna® testing."

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