In a release, the Company noted:
The study, titled, "The PAM50 Risk-of-Recurrence Score Predicts Risk for Late Distant Recurrence after Endocrine Therapy in Postmenopausal Women with Endocrine-Responsive Early Breast Cancer" was conducted by researchers from the
"There is an urgent unmet clinical need to accurately differentiate breast cancer patients who remain at high risk of distant recurrence beyond five years after diagnosis," said senior author
Study authors found that the Prosigna Breast Cancer Assay significantly increased prognostic accuracy with respect to late distant recurrence compared to a score based on clinical factors alone. Between years five and 15 after diagnosis in patients who had not had a recurrence at five years, patients categorized as low risk by the Prosigna Assay demonstrated a risk of distant recurrence of 2.4 percent compared to a risk of 17.5 percent in the high-risk group. The ability to accurately assess risk of late distant recurrence was observed for patients with both node-positive and node-negative disease.
"The ability to stratify patients according to risk of late distant recurrence significantly differentiates the Prosigna Assay from other genomic-based breast cancer assays," said
Results described in the
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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