In a release, the Company noted:
The study was based on an analysis of the
The aim of this study was to assess the performance of the ROR (risk of recurrence) score, also known as the Prosigna Score, in estimating distant recurrence-free survival (DFRS) in postmenopausal women with HR+ early-stage breast cancer treated with adjuvant systemic endocrine therapy alone when the assay is performed in a hospital molecular pathology lab. Investigators at the
"This study demonstrates that the added prognostic information provided by the ROR score should aid physicians in stratifying patients into distinct risk categories with different prognoses among node-negative and even node-positive patient populations, thereby potentially helping the clinician to make informed decisions particularly in low risk patients," said
The PAM50 gene signature assigns an intrinsic subtype (i.e., Luminal A, Luminal B, HER2-enriched, and Basal-like) to the tumor that reflects the underlying biology associated with ER and HER2 pathways1. In this study, as in previous studies of the PAM50 gene signature, the Luminal A cohort had a significantly lower risk of recurrence at 10 years compared to Luminal B. Significant and clinically relevant discrimination between low and high-risk groups occurred also within all patients and clinically relevant subgroups. In all patients and in clinically relevant subgroups, the ROR score significantly added prognostic information to standard clinical variables (p less than 0.001).
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by
The Prosigna Assay requires minimal hands-on time and runs on
The nCounter Dx Analysis System is a highly automated and easy- to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory. The nCounter Elements General Purpose Reagents (GPRs) offered by
The Prosigna Breast Cancer Prognostic Gene Signature Assay Intended Use:
In the U.S., the Prosigna 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 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.
2. A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (one to three 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 four or more positive nodes.
Special Conditions for Use:
The Prosigna Assay is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.
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In a release, the Company noted: