"These results highlight the value of considering tumor biology in the diagnostic evaluation of early stage breast cancer," said Dr.
The study authors evaluated the correlation between numerical risk score provided by Prosigna, referred to as the ROR or Prosigna score, and response to a modern neoadjuvant chemotherapy (NAC) regimen consisting of anthracyclines and taxanes. The study demonstrated that ROR score and intrinsic subtype as determined by Prosigna are strong predictors of response to NAC, confirming expectations that high-risk tumors are significantly more responsive to systemic chemotherapy than low-risk tumors. The authors reported that ROR score significantly predicted pathologic complete response to NAC in hormone receptor-positive patients with node-negative or node-positive (1-3 positive nodes) disease (p = 0.027). Further analysis revealed that for every 20 point increase in the ROR score, a patient was 59.1% more likely to respond to NAC. Finally, the authors concluded that intrinsic subtypes, as determined by Prosigna, are predictive of chemotherapy sensitivity, as referenced in the recently updated St. Gallen International Breast Cancer Guidelines.
"This new evidence confirms Prosigna's ability to predict response to chemotherapy," said
Although the reported study results were based on the analysis of core needle biopsies, Prosigna is currently indicated for use with excisional biopsies only. Additionally, 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 potential use of the Prosigna Assay to identify patients who will respond to chemotherapy and the clinical utility of 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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