Medicare coverage.

“Medicare […] will provide limited coverage for the EndoPredict breast cancer gene expression test for the management of post-menopausal women diagnosed with early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive, Her2-negative breast cancer, who are either lymph node-negative or who have 1-3 positive nodes, and for whom treatment with adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors) is being considered.”

MolDX: EndoPredict Breast Cancer Gene Expression Test (37311), effective date 1/30/2018.

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ASCO guidelines on adjuvant systemic therapy for women with early-stage invasive breast cancer.

“[T]he panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer.”

Harris LN, Ismaila N, McShane LM, et al. American Society of Clinical Oncology. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Apr 1; 34(10):1134-50.

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NCCN clinical guidelines for multigene assays.

“Other prognostic multigene assays may be considered to help assess risk of recurrence but have not been validated to predict response to chemotherapy.”

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) – Breast Cancer, Version 2.2016.

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Positive review from Evidence Street.

“The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.”

BlueCross BlueShield Association. Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients With Breast Cancer. Evidence Street, Current Review Date: December 2016.

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