SEATTLE & SAN FRANCISCO -- (BUSINESS WIRE) -- NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the global commercial launch of the nCounter Elements™ General Purpose Reagents (GPRs), a solution that enables clinical laboratories to independently develop multiplexed genomic assays and then rapidly translate those assays into clinical diagnostics as Laboratory Developed Tests (LDTs). The announcement, made at the 21st International Molecular Medicine Tri-Conference (TRI-CON) taking place in San Francisco, February 9 – 14, marks the conclusion of a successful early access program that involved 22 participants from five countries in North America, Europe, and Asia.
Using nCounter Elements laboratories can independently design and develop custom assays for gene expression, copy number variation, or gene fusions for up to 216 custom targets of interest in a single tube. The nCounter Elements reagents have been listed with the U.S. Food and Drug Administration (FDA) as GPRs, and are available for use in developing LDTs, pursuant to a licensing arrangement offered by NanoString. In addition, the highly flexible architecture of nCounter Elements enables a broad range of basic research studies where iterative design and refinement of assays are important.
The commercial launch was preceded by a successful early access program that included 22 participants from the U.S., Canada, China, Germany, and Denmark. Of those who participated, 67 percent were involved in translational and clinical research, with 50 percent focused on cancer specifically. Of the early access projects, approximately 25 percent were investigating expressed fusion genes, indicating strong interest in the potential of multiplexed fusion assays as a replacement for singleplex fluorescence in situ hybridization (FISH), quantitative polymerase chain reaction (qPCR), and immunohistochemistry (IHC) assays.
"The nCounter Elements chemistry provides a path for laboratories to rapidly translate biomarkers and gene signature discoveries into clinically useful tools," said Lisa Rimsza M.D., Professor of Pathology at the University of Arizona and Principal Investigator of the Lymphoma & Leukemia Molecular Profiling Project (LLMPP) research consortium. "The LLMPP's Lymph2Cx assay was developed on the nCounter platform. We recently tested this signature with the new Elements chemistry and observed that it provided the same high-quality data as NanoString's standard chemistry. Several members of the LLMPP consortium are now interested in incorporating Elements chemistry into assays they develop for lymphoma profiling in their own laboratories."
In November 2013, NanoString launched the nCounter® Dx Analysis System for use in performing high-complexity assays in CLIA-certified laboratories. The System’s multi-mode FLEX configuration provides a single platform with the flexibility to run the nCounter Prosigna™ Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and facilitate the development of multiplexed clinical assays. The nCounter Dx Analysis System is the only platform 510(k) cleared by the FDA to run the Prosigna Assay.
“The success of the Elements early access program further demonstrates that the nCounter Analysis System is the ideal platform to advance disease research, validate discoveries, and translate them into clinically useful molecular testing assays,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “As we continue to broaden our portfolio of solutions across the value chain, from research to clinical tests, we are pleased to deepen our partnerships with laboratories around the world that are enabling personalized medicine to reach more patients than possible today with in vitro diagnostics alone.”
Joseph M. Beechem, Ph.D., Senior Vice President of Research and Development will discuss nCounter Elements during a TRI-CON presentation on Tuesday, February 11th at 3:50PM Pacific Time. For more information, please visit http://www.nanostring.com/community/events.
For more information on nCounter Elements, please visit www.nanostring.com/nCounterElements.
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 360 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected capabilities of nCounter Elements and the use of nCounter Elements to develop clinical assays. 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; 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.
NanoString®, NanoString Technologies®, nCounter®, and nCounter Elements™ are registered trademarks or trademarks of NanoString Technologies, Inc.