"In line with our expectations, Prosigna is now recognized in the NCCN guidelines as providing clinically validated prediction of a woman's risk of breast cancer recurrence," said
The NCCN Guidelines are an authoritative source of information to help healthcare professionals make informed decisions about cancer care, and are often used by public and private payors to establish coverage policies. Prosigna's acknowledgement in the NCCN Guidelines resulted from a review by a multidisciplinary panel of experts from NCCN member institutions, and is based on requests and clinical data submitted in
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.
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 four or more positive nodes.
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 impact of inclusion in the NCCN Guidelines on the market for Prosigna. 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
Leigh Salvoof Westwicke Partnersleigh.firstname.lastname@example.org 415-513-1281
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