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Intended Use/Purpose
The Prosigna ® Breast Cancer Prognostic Gene Signature Assay is intended for in vitro diagnostic (IVD) and is CE- and FDA-certified. The Prosigna test is clinically validated in more than 2,400 patients in two clinical trials (TransATAC and ABCSG-8) and provides Level 1 evidence of clinical validity (tested in randomized controlled trials; accepted as the most reliable evidence).
The assay provides detailed information about the tumor subtype and the patient’s risk of distant recurrence by measuring gene expression profiles. Therefore, total RNA derived from formalin-fixed, paraffin-embedded (FFPE) tissue of breast cancer patients is used.
Clinical parameters and the gene expression profile are used to identify tumor subtypes (luminal A, luminal B, HER2-enriched or basal-like) and to calculate a Risk of Recurrence (ROR). The ROR provides information about the probability of distant recurrence of the disease. Further information can be found on the Prosigna ® webpage.
Information for patients:
The Prosigna ® Breast Cancer Prognostic Gene Signature Assay is a prognostic assay, indicated for patients with Hormone Receptor-Positive (HR+) breast cancer in early stage that are either lymph node-negative (Stage I and II) or lymph-node positive (one or more positive nodes, Stage II and IIIA).
According to the guidelines, gene expression tests are indicated in cases where standard histopathology in conjunction with clinical parameters is not sufficient for treatment decision.
In patients with a low risk of distant metastases, endocrine treatment alone is sufficient and adjuvant chemotherapy can be spared, whereas patients with a high risk of recurrence (ROR) need additional adjuvant chemotherapy.
Information for physicians:
The Prosigna ® Breast Cancer Prognostic Gene Signature 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:
a.) 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 and II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
b.) 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, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
Principle of the Prosigna ® algorithm for output calculation
The test is based on the PAM50 gene signature, which uses the expression profile of 50 genes to identify the intrinsic subtype of the breast tumor tissue investigated (luminal A, luminal B, HER2-enriched or basal-like). A computational algorithm, based on a Pearson’s correlation, compares the expression profile of the 50 genes after normalization. The patient test sample is assigned to one of the mentioned subtypes with respect to the highest Pearson’s correlation.
Besides, a Risk of Recurrence (ROR) score on a 0-100 scale (0%-100%) is calculated by the algorithm. The ROR gives information about the probability of distant recurrence of the disease at ten years for post-menopausal women with a hormone receptor-positive, early stage breast cancer. Additionally to the 0-100 % ROR score, a risk category is assigned (low risk <10%, intermediate risk 10-20% or high risk >20% to have distant recurrence).
The test provides highly precise and reproducible results across multiple laboratories.