On July 7, 2015 NanoString Technologies reported the publication of a study online in Clinical Cancer Research that reinforces the ability of the company’s Prosigna Breast Cancer Assay to inform physician treatment decisions by predicting which patients are most likely to benefit from chemotherapy (Press release, NanoString Technologies, JUL 7, 2015, View Source [SID:1234506184]). The study, entitled "Prediction of Response to Neoadjuvant Chemotherapy Using Core Needle Biopsy Samples with the Prosigna Assay," was conducted in collaboration with Spanish researchers from Vall d’Hebron Institute of Oncology (VHIO), University of Barcelona, and University Hospital ‘Virgen de la Victoria’ of Malaga. The publication can be found online at View Source
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"These results highlight the value of considering tumor biology in the diagnostic evaluation of early stage breast cancer," said Dr. Aleix Prat, Head Medical Oncology Department at Hospital Clínic, University of Barcelona and Principal Investigator. "The results also support the findings of prior studies, which have shown that ROR score and intrinsic subtype are strong predictors of response to chemotherapy."
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 Brad Gray, President and Chief Executive Officer of NanoString. "These results are complementary to the large body of data showing that Prosigna identifies women who are at such low risk that they may be spared overtreatment with chemotherapy."
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 the United States, the Prosigna patient report does not include information related to intrinsic subtype.
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 Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.
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 United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand, Turkey, South Africa and Hong Kong.
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.