November 12, 2013

NanoString Launches the nCounter Dx Analysis System for U.S. Market

Multi-Mode System Available for Running the Prosigna Breast Cancer Assay,
Other Multiplexed Research Assays, and Laboratory Developed Tests

SEATTLE--(BUSINESS WIRE)-- NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced the availability of the nCounter® Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is the only platform 510(k) cleared by the U.S. Food and Drug Administration to run the Prosigna™ Prognostic Breast Cancer Gene Signature Assay. For clinical laboratories that value flexibility, the FLEX configuration offered on the nCounter Dx Analysis System supports other translational research applications, and facilitates the ability of laboratories to develop their own assays. NanoString will showcase the new nCounter Dx Analysis System and its advanced capabilities at this week's annual Association for Molecular Pathology (AMP) conference in Phoenix, Arizona.

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 nCounter Dx Analysis System supports the Prosigna Breast Cancer Prognostic Gene Signature Assay, an in vitro diagnostic assay that uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence of disease. Using the nCounter Dx Analysis System, the Prosigna Assay can be performed in qualified clinical laboratories throughout the U.S. and countries that accept the CE Mark, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients for determining the risk of distant disease recurrence.

The nCounter Dx Analysis 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 clinical laboratory. The nCounter Elements™ General Purpose Reagents (GPRs) offered by NanoString provide further flexibility by enabling laboratories to develop their own gene expression, copy number variation, and gene fusion signatures.

"We have received significant interest from laboratories seeking to perform the Prosigna Breast Cancer Assay as well as run genomic assays that they have developed independently," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "With the nCounter Dx Analysis System's FLEX configuration, the Prosigna Breast Cancer Assay, and with our recently launched nCounter Elements GPRs, we have a compelling suite of products for these laboratories. We expect the versatility of this offering to help drive the adoption of the Prosigna Breast Cancer Assay and be particularly appealing to high-complexity CLIA laboratories in major U.S. cancer centers."

"We're excited to be the first laboratory in the U.S. to adopt the nCounter Dx Analysis System," said Dr. Edward E. Partridge, Director of the University of the Alabama Comprehensive Cancer Center. "In addition to running the Prosigna Assay, which we believe will help inform the treatment decisions clinicians and patients make regarding breast cancer care, we find great value in also using the system to translate our research into our own Laboratory Developed Tests."

When used together, the nCounter Dx Analysis System and Prosigna Breast Cancer Prognostic Gene Signature Assay provide the following key features:

  • High-throughput workflow allowing each nCounter Dx Analysis System to perform the Prosigna Assay on up to 30 patient samples per eight hour work day and obtain assay results in as little as two days
  • Ready-to-use Prosigna Assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • Automated generation of personalized full-color Prosigna Assay patient reports that can be quickly and easily shared electronically with ordering oncologists, and which includes the patient's Prosigna Score and risk category

The nCounter Dx Analysis System is now available for purchase or through reagent rental arrangements in the U.S. and countries that accept the CE Mark. Prosigna testing services are expected to be available from qualified laboratories in the U.S. beginning in the first quarter of 2014.

About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay

Prosigna 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, which are then used to assess a patient's risk of distant recurrence. 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 Prosigna Assay will be available for diagnostic use when ordered by a physician in the U.S. 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 and in which Prosigna is registered.

Prosigna™ Breast Cancer Prognostic Gene Signature Assay Intended Use:

The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence. The assay measures the gene expression profile using RNA extracted from formalin-fixed, paraffin embedded (FFPE) breast tumor tissue. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, for assessment of the risk of distant recurrence of disease. The assay is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy 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:

Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.

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, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 300 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company's technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. The company's technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic assay to be marketed through the company's diagnostics business. The nCounter Dx Analysis System is FDA 510(k) cleared for use with the Prosigna Breast Cancer Prognostic Gene Signature Assay. To date, it has not been cleared by the FDA for other indications or for use with other assays.

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

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 expected market acceptance of the nCounter Dx Analysis System, the Prosigna Assay, and nCounter Elements GPRs, and the expected adoption of the Prosigna Assay by clinicians and their patients. 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 our 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; 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.

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

Investor Contact:
For NanoString Technologies
Lynn Pieper of Westwicke Partners
415-202-5678
lynn.pieper@westwicke.com
or
Media Contact:
For NanoString Technologies
Maurissa Messier of Bioscribe Inc.
760-539-7417
Maurissa@bioscribe.com

Source: NanoString Technologies, Inc.

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