The Prosigna Score Provides Important Information for Node-Negative and Node-Positive (1-3 Nodes) Breast Cancer Patients in the First 5 Years and 5 to 10 Years After Diagnosis
The Prosigna FDA labeling now provides greater insight into observed risk of distant recurrence five to 10 years after diagnosis, which includes:
- The identification of low risk node-negative patients, who have 1.3 percent probability of distant recurrence between years five and 10.
- Additionally, the identification of a low-risk portion of node-positive patients who have 3.7 percent probability of distant recurrence between years five and 10.
"We are pleased that the Prosigna labeling has been updated to highlight
that the Prosigna Score provides insight into the probability of distant
recurrence events in the first five years, while patients are receiving
endocrine therapy, and between years five and 10 after diagnosis,
following completion of endocrine therapy," said
"As we have previously reported in a paper published earlier this year
About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter® Dx Analysis System
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 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 or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 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. The Prosigna Assay is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.
For more information, please visit www.prosigna.com.
For more information, please visit www.nanostring.com.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding the potential use of the Prosigna Assay
to identify patients at risk of distant disease recurrence 5-10 years
after diagnosis and the potential of Prosigna to inform both the
use of adjuvant chemotherapy and the use of extended adjuvant endocrine
therapy based on a single risk score. Forward-looking statements are
subject to risks and uncertainties that could cause actual results to
differ materially and reported results should not be considered as an
indication of future performance. These risks and uncertainties include,
but are not limited to: risks associated with keeping pace with rapidly
changing technology and customer requirements; risks regarding the
company's ability to successfully introduce new products; risks that new
market opportunities may not develop as quickly as expected; risks
associated with competition in marketing and selling products; risks of
increased regulatory requirements; risks associated with obtaining
reimbursement coverage for Prosigna; as well as the other risks set
forth in the company's filings with the
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