The results were based on the combined analysis of 2,137 postmenopausal
women with HR+ early-stage breast cancer enrolled in the
"Better tools for informing the important decision of endocrine therapy
duration are urgently needed. Not only does this data establish the
Prosigna Assay as a clinically meaningful test for determining risk of
late recurrence, it shows that Prosigna is capable of providing
prognostic information for both 10-year distant recurrence and late
distant recurrence," said
The combined analysis of 2,137 patients is based on long-term follow-up data and tissue samples from postmenopausal women with HR+ early-stage breast cancer who received five years of endocrine treatment and did not have a recurrence in the first five years following diagnosis. The primary objective of this study was to determine if the Prosigna ROR Score provides prognostic information in the period after the first five years following diagnosis. The time from year five post diagnosis to first distant recurrence was the prospectively defined primary endpoint. Using the Prosigna Assay to generate a Prosigna ROR Score, women categorized into the high-risk group had 16.6 percent risk of distant recurrence in years five to ten, those in the intermediate group had a risk of 8.3 percent, and those categorized into the low risk group had a risk of only 2.4 percent.
"It has been previously shown that the PAM50-based ROR score is
significantly correlated with distant recurrence in each of the
TransATAC and ABCSG8 randomized trials," said
Data from this study, titled, "Prediction of Late Distant Recurrence
After 5 Years of Endocrine Treatment: A Combined Analysis of Patients
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.
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.
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 late distant disease recurrence 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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