Assay Design Technology Licensed from Harvard University Expands Utility of nCounter Elements

SEATTLE & CHICAGO--(BUSINESS WIRE)-- NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that it has expanded the capabilities of its nCounter Elements™ General Purpose Reagents (GPRs) with the addition of a universal junction probe design that offers specific detection and analysis of known fusion genes. The company announced the availability of the new design capability to early access customers at the 2014 American Association for Clinical Chemistry annual meeting in Chicago.

Brad Gray, President and Chief Executive Officer of NanoString Technologies commented: "With this new technology, NanoString can now design probes for virtually any fusion junction. As a result, our customers can design and develop full custom sets of probes for their fusion junction sequences of interest. We are proud to partner with the Wyss Institute at Harvard University to bring this latest advance to the market and further bolster our growing portfolio of validated tools for cancer research and personalized medicine."

Fusions genes are hybrid genes formed from two previously separate genes. An increasing number of these genes are being recognized as important diagnostic and prognostic indicators in human cancers and diseases. nCounter Elements GPRs enable clinical laboratories to independently develop multiplexed genomic assays and then rapidly translate those assays into clinical diagnostics as Laboratory Developed Tests (LDTs).

NanoString has developed the capability to design probes to the unique junction sequence that is formed when two genes fuse to one another. These probes can be combined with nCounter Elements GPRs to create assays to detect known fusion events. The universal junction probe design method can be combined with a previously published method, capable of detecting unknown fusion events.

NanoString's new junction probe design was created based on technology developed by Peng Yin Ph.D., core faculty member at the Wyss Institute for Biologically Inspired Engineering at Harvard University and assistant professor at the Department of Systems Biology at Harvard Medical School, and David Zhang, former Postdoctoral Fellow at the Wyss Institute and Ted Law Jr. Assistant Professor of Bioengineering at Rice University.

Comprehensive fusion assays, based on these design methods, can accurately detect fusion events in formalin-fixed, paraffin embedded (FFPE) and fresh frozen patient tissue as well as cell lines. Flexibility in design options and multiplexing capabilities enable development of assays for a variety of applications from discovery to diagnostics.

"These multiplexed fusion assays offer an alternative to singleplex FISH, qPCR, and IHC assays that maximizes the information generated from scarce samples and enables the addition of new fusions without an increase in sample input amount or labor," said Dr. Mao Mao, Senior Vice President of Translational Bioscience and Diagnostics at Wuxi AppTec.

This offering expands on NanoString's established strength in fusion gene analysis as previously published in "A Single-Tube Multiplexed Assay for Detecting ALK, ROS1, and RET Fusions in Lung Cancer"; The Journal of Molecular Diagnostics, Volume 16, Issue 2, March 2014.

The nCounter Elements reagents are available for use in developing LDTs, pursuant to a licensing arrangement offered by NanoString.

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 400 peer-reviewed publications. The nCounter Analysis 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, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology has now 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, and nCounter are registered trademarks, and Prosigna and nCounter Elements are trademarks of NanoString Technologies, Inc.

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Source: NanoString Technologies, Inc.

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