Prosigna Breast Cancer Prognostic Gene Signature Assay

The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test), made by NanoString, is a genomic test that analyzes the activity of certain genes in early-stage, hormone-receptor-positive breast cancer.

May be used to help make treatment decisions based on the risk of distant recurrence for postmenopausal women within 10 years of diagnosis of early-stage, hormone-receptor positive disease with up to three positive lymph nodes after 5 years of hormonal therapy treatment.

Can categorize breast cancer into luminal A, luminal B, HER2 and basal subtypes.

The Prosigna is used on breast cancers diagnosed in postmenopausal women that are:

stage I or stage II and lymph node-negative

stage II with one to three positive nodes



have been treated with surgery and hormonal therapy

The Prosigna assay is performed on preserved tissue that was removed during the original biopsy or surgery.

The assay looks at the activity of 58 genes to estimate the risk of distant recurrence of hormone-receptor-positive breast cancer from 5 to 10 years after diagnosis after 5 years of hormonal therapy treatment in postmenopausal women.

The Prosigna assay results are reported as a risk of recurrence (ROR) score from 0 to 100 in two ways:

node-negative cancers pare classified as low (0-40), intermediate (41-60), or high (61-100) risk node-positive cancers are classified as low (0-40) or high (41-100) risk.

Prosigna assay, helps to determine whether to continue hormonal therapy for 5 more years by using data,


the size of the cancer

cancer grade

lymph node involvement.

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