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nCounter Elements General Purpose Reagents are First NanoString Product with Open Architecture to Support Independent Development of Diagnostic Tests
NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced an Early Access Program for nCounter Elements™, a line of General Purpose Reagents (GPRs) developed specifically to meet the needs of translational research and clinical laboratories. nCounter Elements GPRs enable researchers to independently develop multiplexed genomic assays, and then rapidly translate those assays into clinical diagnostics offered as Laboratory Developed Tests. The company made the announcement at the annual meeting of the American Association for Clinical Chemistry (AACC) taking place in Houston from July 28 - August 1.
Since the completion of the sequencing of the human genome, many clinically relevant biomarkers and signatures have been identified that offer enormous potential to improve human health. However, the rate of translating these discoveries into clinically useful tools has lagged. A major challenge has been developing and validating highly multiplexed assays that can both reliably test clinical samples, such as tissue biopsies stored as Formalin-Fixed Paraffin Embedded (FFPE) samples, and be easily implemented in a clinical laboratory. With nCounter Elements GPRs, this challenge can be met.
"This launch further supports NanoString's vision of helping researchers to advance their understanding of disease, and then directly apply that knowledge to molecular diagnostics," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "By opening our technology to laboratories developing innovative diagnostics, we can accelerate the growth of our business in clinical laboratories and reach even more patients than we could through the development of in vitro diagnostic products alone."
nCounter Elements is a new digital molecular barcoding chemistry that allows users to assemble their own customized assays using standard sets of barcodes provided by NanoString and probes that they can purchase independently from an oligonucleotide manufacturer. The nCounter Elements reagents have been registered with the Food and Drug Administration as a General Purpose Reagent, and are available for use in developing Laboratory Developed Tests, pursuant to a licensing arrangement to be 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.
Laboratories will now be able to independently develop custom, multiplexed assays to detect gene expression, copy number variations, and gene fusions that generate reliable results from a diverse range of sample types including FFPE samples. By enabling rapid, robust analysis of up to 216 targets per reaction with only 3 pipetting steps per sample, nCounter Elements offer translational researchers and clinical laboratories a powerful new tool for developing and validating Laboratory Developed Tests based on recent genomic discoveries.
NanoString has beta-tested the nCounter Elements reagents with existing customers developing potential cancer diagnostics based on gene expression signatures. "We are interested in using nCounter Elements to develop a clinical test based on a gene expression signature that was validated with NanoString's original chemistry," said Cynthia Hawkins, a neuropathologist at the Hospital for Sick Children in Toronto. "A major advantage of nCounter Elements chemistry is its compatibility with FFPE samples. We are pleased that the preliminary results from the nCounter Elements beta testing show high correlation between matched Fresh-Frozen and FFPE samples."
Customers in the Early Access Program will receive the first shipments of nCounter Elements GPRs during the third quarter of 2013. Early access customers will receive a starter package to support initial experiments and have the opportunity to provide feedback on the product prior to full commercialization.
For more information, please visit www.nanostring.com/nCounterElements.
About NanoString Technologies, Inc.
NanoString Technologies is a provider of 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 220 peer-reviewed publications, has also now been applied to diagnostic use in the European Union. The system 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 kit to be marketed through the company’s diagnostics business.
The nCounter Analysis System is available for “Research Use Only” in North America. For more information, please visit www.nanostring.com. The Prosigna Assay has received a CE mark 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; it is pending 510(k) clearance with the Food and Drug Administration and is not available for sale in the United States.
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 timing of the product launch, the expected capabilities of nCounter Elements, the use of nCounter Elements to develop Laboratory Developed Tests and the impact of the product launch on the company’s business. 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 and nCounter Elements are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.
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