National Institute of Health and Care Excellence (NICE) – Guidance for patients with early breast cancer.

“EndoPredict (Epclin score), Oncotype DX® Breast Recurrence Score and Prosigna® are recommended as options for guiding adjuvant chemotherapy decisions for people with [ER-positive, HER2-negative], and lymph node-negative early breast cancer.”

NICE Guidance – December 19, 2018

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ASCO guidelines on Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer.

“Many women with node-negative breast cancer should consider extended therapy for up to a total of 10 years of adjuvant endocrine treatment based on considerations of recurrence risk using established prognostic factors [stage, grade, and genomic signatures].”

Burstein HJ, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO Clinical Practice Guideine Focused Update. J Clin Oncol. 2018 Nov 19. Epub ahead of print

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NCCN® Clinical Guidelines – Breast Cancer.

“Consider multigene assay to assess prognosis and determine chemotherapy benefit.”

EndoPredict receives Category 2A Evidence and Consensus for both node-negative and node-positive patients (1-3 nodes).

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) – Breast Cancer. Version 2.2018

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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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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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