Use PAM50 to generate an individualized Prosigna Score* for every patient¹.
Every Prosigna Score is generated by a proprietary algorithm1
- The Prosigna Score is a numerical value on a 0-100 scale that correlates with the probability of distant recurrence within 10 years.
- The gene expression profile of a patient's tumor is compared with each of the 4 PAM50 prototypical molecular profiles to determine the degree of similarity. The results in combination with a proliferation score and tumor size produce an individualized Prosigna Score.
Intended use/indications for use: The Prosigna Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient's risk of distant recurrence of disease. The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
- A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal 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.
- A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-positive (1-3 positive nodes), stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.
*Prosigna Score is Prosigna's proprietary model for predicting risk of recurrence in a patient. PAM50 molecular subtype not reported in the United States.
1. Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc; 2013.
2. Nielsen T, McDonald S, Kulkarni S, et al. Analytical reproducibility of the breast cancer intrinsic subtyping test and nCounter® Analysis System using formalin-fixed paraffin-embedded (FFPE) breast tumor specimens. Poster presented at: 102nd United States and Canadian Academy of Pathology Annual Meeting; March 2-8, 2013; Baltimore, MD. Abstract 2075.
3. Gnant M, Filipits M, Mlineritsch B, et al; Austrian Breast and Colorectal Cancer Study Group. Clinical validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant-recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): an ABCSG study. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX. Abstract P2-10-02
Prosigna is indicated for in vitro diagnostic use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer to be treated with adjuvant endocrine therapy for assessment of risk of distant recurrence of disease.