NanoString Highlights Progress on Product Roadmap

Hyb & Seq Single Molecule Chemistry Sequences Oncogenes from FFPE Samples with High Accuracy and Simple Workflow Free of Library, Enzymes and Amplification

3D Biology Enables Simultaneous Detection of Somatic DNA Mutations and Expressed Fusion Transcripts plus Expression Profiling of Proteins from Lung-Tumor FFPE Samples

Digital Spatial Profiling of RNA and Protein Expression in Tumor Microenvironment from FFPE Tissue Sections

HOLLYWOOD, Fla., Feb. 16, 2017 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ: NSTG ), a provider of life science tools for translational research and molecular diagnostic products, today highlighted advancements of a series of innovative technologies designed to open up new possibilities for biologic research and diagnostics of the future at the Advances in Genome Biology and Technology (AGBT) conference in Hollywood, Florida.  With the novel library-free Hyb & Seq™ sequencing chemistry, the ability to spatially map both gene and protein expression using Digital Spatial Profiling technology, and 3D Biology™ assays enabling the simultaneous measurement of DNA mutations, RNA and protein expression, NanoString’s optical barcoding technology provides an unparalleled platform to comprehensively characterize the biology of a sample.  These technologies were showcased in two oral presentations and four posters at the AGBT 2017 meeting, in what is the largest display of new technology advancements in company history. 

“The capabilities highlighted this week are the product of an unprecedented period of innovation at NanoString, and illustrate how we are harnessing the full potential of our optical barcoding technology,” said Brad Gray, president and CEO of NanoString Technologies. “We’re proud of the tremendous progress that our R&D team has made on these programs over the past year, and we look forward to translating these innovations into a powerful suite of research and diagnostic products over the next several years.”

Hyb & Seq The Hyb & Seq chemistry is designed to enable a workflow that is simpler and faster than current sequencing methods due to the absence of library preparation, enzymes and amplification.  Hyb & Seq’s simple workflow and compatibility with a variety of sample types would make it ideally suited for targeted clinical sequencing. This chemistry is also unique in providing both short and long read capability simultaneously, as well as the ability to sequence both DNA and RNA in parallel. In proof-of-concept experiments using well defined reference standard reagents, Hyb & Seq chemistry demonstrated a low intrinsic error rate, and the ability to provide high consensus accuracy at low coverage by non-destructively sequencing the same native molecule multiple times.

“Hyb & Seq is a brand-new sequencing chemistry, based entirely on hybridization.  It offers high accuracy, flexibility, and simplicity that potentially enable a wide range of clinical applications where rapid sample-to-answer capability is advantageous,” stated Joe Beechem, Ph.D., senior vice president of R&D for NanoString. “While we are still early in the development of this platform, we have moved from proof-of-concept to targeted sequencing on difficult FFPE samples in only 12 months, demonstrating the potential commercial viability of this novel chemistry.”

Hyb & Seq chemistry was described in one oral presentation by Dr. Beechem and three posters, highlighting the unique attributes of the platform:

• Total processing time from FFPE curls to start of sequencing was under 60 minutes, with total hands-on time of less than 15 minutes
• Current un-optimized target capture from one to three FFPE curls (10 microns thickness) was sufficient for sequencing with no PCR amplification
• Targeted sequencing of 11-plex oncogene panel, yielding QV40 sequence quality on bases with 5x coverage
• Simultaneous direct sequencing of DNA and RNA using as little as 1 to 10 ng of total RNA
• Long-read capability, with reads up to 33kB in length demonstrated to date and no theoretical upper limit to read length
• Two separate and independent assemblers developed to date, yielding similar results

Hyb & Seq technology’s simplicity, flexibility, and accuracy offers an ideal sample-to-answer solution for the sequencing lab.  Hyb & Seq technology is currently for research use only and is not for use in diagnostic procedures.  The company is currently evaluating alternatives for the further development of the Hyb & Seq instrument, including corporate and academic partnerships.

3D Biology

3D Biology enables a unique application of the company's proprietary optical barcoding technology for measurement of DNA, RNA, and protein simultaneously in a single experiment. 3D Biology applications enable researchers to make entirely new observations about cancer biology while maximizing the data generated from precious samples.  3D Biology assays are currently commercially available under NanoString’s Vantage 3D™ line of products.

3D Biology results were presented by Julia Kargl, PhD of Medical University of Graz in a plenary session titled 3D Biology™ View of Cancer: Simultaneous Detection of Somatic DNA Mutations and Expressed Fusion Transcripts Plus Expression Profiling of Phosphor and Total Signaling Proteins From Lung-Tumor FFPE Samples .  In this study, a cohort of over 40 lung cancer patient samples were assayed simultaneously with an SNV panel targeting over 100 solid tumor somatic mutations, a lung cancer fusion gene panel targeting ALK, RET, ROS1 and NTRK1 transcripts, and a protein panel measuring over 25 targets, including key members of the EGFR, PI3K, and MAPK signaling pathways.  Combined with separately collected 770-plex RNA profiling of key cancer pathways and 770-plex immune gene expression analysis, this multidimensional dataset points the way to a new generation of molecular biomarker-based signatures of disease.

3D Biology assays are for research use only and are not for use in diagnostic procedures.

Digital Spatial Profiling

NanoString's Digital Spatial Profiling (DSP) technology enables the precise quantification of protein and gene expression spatially for regions of interest across the landscape of a heterogeneous FFPE tumor slice. Regions of interest can be any shape and size, down to a single cell level. Combining both multiplexed nucleic acid and protein on the same platform gives researchers the ability to spatially measure RNA when suitable antibodies do not exist. The platform includes imaging and fluidic components to capture spatial context, and current nCounter® instruments provide the quantification.

DSP technology was described in a poster titled Spatially resolved, multiplexed digital characterization of RNA and protein expression in FFPE tissue sections: Application to high-plex profiling of tumor microenvironments. NanoString is currently accepting applications to a Technology Access Program for its DSP technology at TAP@Nanostring.com .  A DSP instrument system is under development and is expected to be commercially available in late 2018. The DSP instrument is intended for research use only and is not intended for use in diagnostic procedures.

Other poster presentations included:

#205: Direct single-molecule RNA sequencing without cDNA conversion using Hyb & SeqTM chemistry - Margaret Hoang, Ph.D., Scientist II

#302: Single-molecule long read sequencing using Hyb & Seq™ chemistry - Mark McElwain, Ph.D., Scientist II

#705: ShortStack™ Technology: Accurate, reference-guided assembly of Hyb & Seq ™ reads for targeted sequencing to resolve short nucleotide variants and InDels - Erin Piazza, Ph.D., Bioinformatics Scientist

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 more than 1,450 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 is also being used in diagnostics. 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. In addition, the company is collaborating with multiple biopharmaceutical companies in the development of companion diagnostic tests for various cancer therapies, helping to realize the promise of precision oncology. For more information, please visit www.nanostring.com .

Forward-Looking Statements  This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the expected performance of the company’s Hyb & Seq chemistry and its potential superiority to existing sequencing methods, the company’s Hyb & Seq chemistry’s potential role as the basis for development of a DNA-sequencing instrument for clinical applications, the commercial potential of the company’s Hyb & Seq chemistry and the anticipated timing for the commercial release of the DSP instrument. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include market acceptance of our products; delays or denials of regulatory approvals or clearances for products or applications; delays or denials of reimbursement for diagnostic products; the impact of competition; the impact of expanded sales, marketing, product development and clinical activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or clinical studies; adverse conditions in the general domestic and global economic markets; 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, nCounter SPRINT, 3D Biology, Hyb & Seq and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.  

Contact: Doug Farrell Vice President, Investor Relations & Corporate Communications dfarrell@nanostring.com Phone: 206-602-1768