A-Z Test List IHC ISH Molecular

Prosigna Breast Cancer Assay

The Prosigna Breast Cancer Assay is a NICE-approved test for risk stratification and molecular sub-typing of early breast cancer using the nCounter Dx. It uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence.

The test is based on PAM50, the 50-gene classifier algorithm; the algorithm uses the 50‑gene expression profile to assign breast cancer to one of four PAM50 intrinsic molecular subtypes.

RNA is extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue, previously diagnosed as invasive breast carcinoma. The gene expression data are weighted together with clinical variables to report on:

• Risk Group (Low, Intermediate, High)
• Risk of Recurrence (ROR) Score
• Intrinsic Subtype (Luminal A, Luminal B, HER2-enriched, Basal-like)

The Prosigna Breast Cancer Assay is indicated in female breast cancer patients who have undergone either mastectomy or breast‑conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as:

1. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
2. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1–3 positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.

This test is not on our current UKAS (ISO15189:2012) scope of accreditation.

Further test information: www.prosigna.com/en-gb/

Please contact the laboratory to order this test.