Clinical Validation


Proven ability to add significant prognostic information beyond clinical factors

The prognostic significance of Prosigna was proven in the ABCSG-8 study, published in Annals of Oncology, which consisted of more than 1400 patient samples1

  • Study cohort consists of formalin-fixed paraffin-embedded (FFPE) breast tumor tissue samples retrospectively collected and archived in the Austrian Breast & Colorectal Cancer Study Group (ABCSG) tumor bank from patients enrolled in the ABCSG-8 trial1.
  • Postmenopausal women with hormone receptor-positive breast cancer were randomized prior to treatment to 2 years of adjuvant tamoxifen followed by either 3 years of anastrozole or 3 years of adjuvant tamoxifen1,2.
  • Re-consented >1200 patients2.
  • Clinical treatment score (CTS) was derived from standard clinical covariates, including age, grade, tumor size, nodal status, and adjuvant therapy1.

ABCSG-8 Objectives1

  • Determine whether the Prosigna Score adds prognostic information beyond the CTS.
  • Determine whether the Prosigna Score-based risk groups of low, intermediate, and high add prognostic information beyond the CTS.

Get more prognostic information beyond standard clinical variables

  • Both the Prosigna Score and risk group add statistically significant prognostic information beyond the CTS (P<0.0001)1,2
  • In node-negative patients, the 10-year distant recurrence-free survival (DRFS) rates were >95% for the low-risk group, 90.4% for the intermediate-risk group, and <85% for the high-risk group1
  • In node-positive patients, the 10-year DRFS rates were 94.2% for the low-risk group and 75.8% for the high-risk group1

1. Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc.; 2013.
2. Gnant M, Filipits M, Greil R, et al; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014;25(2):339-345.

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.