MolDX: Breast Cancer Assay: Prosigna®

Prosigna testing is covered only for post-menopausal women with ER-positive early breast cancer who are either node-negative (stage I or II) or node-positive with 1–3 involved nodes (stage II). Claims will be denied if the patient does not meet these FDA-specified criteria; medical records must document menopausal status, ER status, nodal involvement, and stage to support coverage.

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

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