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NanoString Technologies Announces Publication of Clinical Study Demonstrating the Ability of Its Prosigna Breast Cancer Assay to Predict Response to Chemotherapy

SEATTLE, July 7, 2015 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced 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. 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 http://clincancerres.aacrjournals.org/content/early/2015/07/07/1078-0432.CCR-15-0630.full.pdf+html.

"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.

About NanoString Technologies, Inc.

NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company's nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in over 700 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology has also been applied to diagnostic use. The Prosigna Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer.

For more information, please visit www.nanostring.com.

The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.

Forward-Looking Statements

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 Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.

CONTACT: Leigh Salvo of Westwicke Partners leigh.salvo@westwicke.com 415-513-1281

Source:NanoString Technologies, Inc.