Cancer Treatment Today

Prosigna is tFDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System. The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

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:
1. A prognostic indicator for distant recurrencefree survival at 10 years in
postmenopausal women with hormone receptorpositive (HR+), lymph
nodenegative, Stage I or II breast cancer to be treated with adjuvant endocrine
therapy alone, when used in conjunction with other clinicopathological factors.
2. A prognostic indicator for distant recurrencefree survival at 10 years in
postmenopausal women with hormone receptorpositive (HR+), lymph nodepositive
(13 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.

This assay was found to be substantailly equivalent to Mammaprint. Based ont aht, I cosndier it as as good as Mammaprint,To my knowledge, it had tno been compared to the OncotypeDx test, but it should be cosndired equivaltn to ti as well and  considered among the best such available tests..

Nielsen T, Wallden B, Schaper C, et al. Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer. 2014;14:177. Published 2014 Mar 13. doi:10.1186/1471-2407-14-177

Vieira AF, Schmitt F. An Update on Breast Cancer Multigene Prognostic Tests-Emergent Clinical Biomarkers. Front Med (Lausanne). 2018;5:248. Published 2018 Sep 4. doi:10.3389/fmed.2018.00248