Prosigna™ Breast Cancer Prognostic Gene Signature Assay

The Prosigna Breast Cancer Prognostic Gene Signature Assay is cleared by the FDA as a prognostic indicator for recurrence risk in breast cancer. The assay is based on the PAM50 gene signature1, 2. This analysis uses mRNA expression data from 50 genes to stratify breast cancers into four “intrinsic” molecular subtypes, which have been demonstrated to have prognostic significance. Further clinical validation was performed retrospectively using more than 1400 breast tumors from the ABCSG-8 clinical trial3. This trial included post-menopausal women with hormone receptor positive (HR+, ie. estrogen/progesterone receptors, ER/PR ), early stage breast cancer treated with 5 years tamoxifen, or 2 years of tamoxifen followed by 3 years of anastrozole. The Prosigna assay results were found to add prognostic information beyond that of clinical treatment score (CTS) based on standard clinical factors, including age, grade, tumor size, nodal status, and adjuvant therapy3. Thresholds were defined for risk groups (low, intermediate, high) on the basis of the Prosigna risk of recurrence score (“ROR”) and nodal status.

Other studies in the literature have reported generally comparable results between Prosigna™/PAM50 and other prognostic indicators for breast cancer4-5. From 1007 patients from the TransATAC study, a comparison of ROR and RS (Oncotype DX) was performed and PAM50 was reported to provide further discrimination within the intermediate risk group, with fewer intermediate classifications compared to Oncotype DX4.

To open a printable assay summary in a new window, click the link below.

Prosigna Breast Cancer Prognostic Gene Signature Assay

(Prognostic indicator for risk of distant recurrence at 10 years in post-menopausal female patients with early stage, hormone receptor-positive, invasive breast cancer)
(in portable document format (pdf) which requires Adobe® Acrobat® Reader™ to view or print; download latest version free)

Please submit the Prosigna Test Request Form (TRF) when ordering this test.


  1. Package Insert: Prosigna Breast Cancer Prognostic Gene Signature Assay;  Version 03, created 2013-11; REF LBL-C0223-03
  2. Parker JS, et al. J Clin Oncol. 2009 Mar 10;27(8):1160-7.
  3. Gnant M, et al. Ann Oncol. 2014 Feb;25(2):339-45.
  4. Dowsett M, et al. J Clin Oncol. 2013 Aug 1;31(22):2783-90.
  5. Kelly CM, et al. Oncologist; 17(4): 492-8, 2012.