About NanoString Technologies

NanoString Technologies, Inc. develops, manufactures, and markets technologies that unlock scientifically valuable and clinically actionable information from minute amounts of biological material, primarily for life science researchers in the fields of genomics and proteomics. The company’s technologies include proprietary chemistries that enable the labeling and counting of single molecules. The company’s product platforms are used for scientific discovery and clinical research applications, often in connection with pharmaceutical product development and human clinical trials of potential new therapies. The company’s proprietary chemistries may reduce the number of steps required to conduct certain types of scientific experiments, enable the collection of multiple data points in a single experiment or allow for multiple experiments to be conducted at once. The company’s chemistries and instruments are also able to extract information from multiple types of biological samples, including those that are often challenging to work with using other scientific methods or platforms. The company’s ecosystem of solutions consists of its spatial biology platforms, including its GeoMx Digital Spatial Profiler, or GeoMx DSP or GeoMx, its CosMx Spatial Molecular Imager, or CosMx SMI or CosMx, and its AtoMx Spatial Informatics Platform, or AtoMx SIP or AtoMx, a cloud-based, open source and fully integrated informatics solution for use with GeoMx DSP and CosMx SMI; and its nCounter Analysis System, its original product platform for multi-plex bulk gene expression analysis. The company’s GeoMx, CosMx and nCounter product platforms include instruments, related consumables, software and services, have the versatility to detect both RNA and protein expression and are able to generate reliable and reproduceable data in a variety of biological sample types, including formalin fixed paraffin embedded, or FFPE, format. The company’s nCounter platform, which was commercially launched in 2008, is used to conduct what is known as bulk gene expression analysis, whereby biological samples are first reduced, or broken down, and then gene expression, specifically quantities of selected RNA or proteins, are measured at their average levels throughout the totality of the sample. nCounter can be used to analyze the activity of up to 800 genes in a single experiment. GeoMx DSP is a pioneering product platform in the emerging field of spatial biology. While nCounter and other common gene expression analysis technologies use bulk analysis approaches, GeoMx DSP is used to analyze selected regions of an intact biological sample without the need to break down the sample, enabling researchers to see how gene expression might vary across those regions. After a researcher selects regions of interest, GeoMx arranges the biological information extracted from these regions to be subsequently quantified and analyzed, or read out, by a platform, such as nCounter, whereby researchers can obtain information on up to 96 biological targets per selected region of interest, or by a next generation sequencer, or NGS, system, such as systems manufactured by Illumina, Inc., whereby researchers can obtain information on up to approximately 18,000 biological targets, or the RNA from every gene in the genome, per selected region of interest. CosMx SMI, which was commercially launched in December 2022, is a new product platform in the field of spatial biology and complements the company’s GeoMx DSP. While GeoMx offers researchers the ability to profile gene expression activity in a selected region of interest that may contain multiple cells or cell types, CosMx is designed to enable multiplexed spatial profiling of RNA and protein targets at a single and sub-cellular resolution level. While GeoMx allows for more rapid, higher throughput analysis of gene expression activity in selected regions of interest, CosMx is designed to allow researchers to drill down into a specific single cell or sub-cellular area in a region of interest to gather more information as desired or required. CosMx can be used to analyze up to 1,010 RNA targets, or up to 68 protein targets, at a single or sub-cellular level of resolution within morphologically intact tissue samples, and is expected after further product development to have the ability to analyze up to 6,000 RNA targets, or up to 120 protein targets. AtoMx SIP, which was commercially launched in December 2022, is a new a cloud-based, open source spatial biology informatics platform, initially for use with CosMx, and eventually also with GeoMx. Researchers’ desire for ever larger amounts of data in their spatial biology experiments has led to significant big data management issues, including the ability to store, access and efficiently analyze experimental data at a reasonable cost. AtoMx is designed to take advantage of significant advances in cloud computing and facilitate the easy storage of large data sets and images generated by spatial biology experiments. AtoMx also enables researchers to perform image analysis and data visualization, as well as sharing of data and analysis with collaborators, using scalable and on-demand cloud computing. AtoMx will enable researchers to easily and quickly analyze the substantial scientific data and tissue images generated by spatial biology experiments, while avoiding the large computing infrastructure and security costs associated with operating in-house data centers. AtoMx is available to researchers using CosMx, and is expected to be made available for GeoMx users by the end of 2023. The company markets and sells its systems and related consumables to researchers in academic, government and biopharmaceutical laboratories for research use, both through its direct sales force and through selected distributors in certain international markets. As of December 31, 2022, the company had an installed base of approximately 350 GeoMx DSP systems, which its customers have used to publish approximately 190 peer-reviewed scientific papers. As of December 31, 2022, the company had an installed base of approximately 1,120 nCounter systems, which its customers have used to publish more than 6,520 peer-reviewed scientific papers. The company’s trademarks and registered trademarks include NanoString, NanoString Technologies, nCounter, nCounter SPRINT, nSolver, GeoMx, CosMx, and AtoMx. Strategy and Solutions The company’s strategy is to offer a portfolio of technologies to genomics and proteomics researchers that are easy to use across multiple experimental scales or approaches, and that offer consistent, accurate and reproduceable scientific results in a variety of biological sample types, including those that may be more challenging to use or analyze with alternative technology platforms. The key elements of the company’s strategy are to complementary solutions that enable spatial biology and bulk gene expression analysis at multiple scales; ease of use and automation; flexible and efficient biological sample requirements; and robust and reproduceable scientific results. Products and Technology The company’s products operate in the spatial biology and bulk gene expression markets, which exist within the larger life sciences technologies market. The company’s ecosystem of spatial biology solutions, which include its GeoMx DSP, CosMx SMI and AtoMx SIP, are designed to seamlessly work together and address researcher needs across both the discovery and translational research markets. nCounter, the company’s first commercially available product, was launched in 2008 and operates within the multi-plex bulk gene expression market and primarily serves the clinical, or translational, research market, often in connection with pharmaceutical product development and human clinical trials of potential new therapies. The company’s nCounter systems can be used for research or clinical diagnostic applications. Products and Technology The company’s products operate in the spatial biology and bulk gene expression markets, which exist within the larger life sciences technologies market. The company’s ecosystem of spatial biology solutions, which include its GeoMx DSP, CosMx SMI and AtoMx SIP, are designed to seamlessly work together and address researcher needs across both the discovery and translational research markets. nCounter, the company’s first commercially available product, was launched in 2008 and operates within the multi-plex bulk gene expression market and primarily serves the clinical, or translational, research market, often in connection with pharmaceutical product development and human clinical trials of potential new therapies. The company’s nCounter systems can be used for research or clinical diagnostic applications. The primary technologies historically used by researchers and clinicians to analyze gene activity in selected parts of a biological sample include immunohistochemistry, or IHC, which is used to estimate amounts of protein, and in-situ hybridization, or ISH, which is used to estimate amounts of RNA. Both IHC and ISH use fluorescent stains that provide the ability to identify typically four proteins or RNA at a time based on assigned colors. The colors aid researchers in identifying where certain proteins or RNA may reside in a sample and provide a visual approximation of amounts. GeoMx is designed to allow researchers to quantify a much larger number of RNA or proteins spatially within multiple regions of interest across the landscape of a heterogeneous section of a biological sample. The company’s GeoMx instrument images slide-mounted or freshly cut sample sections, allowing users to select regions of interest for subsequent quantification and analysis, or molecular profiling. The post-selection profiling or read out, can be performed using either its nCounter Analysis System, or an Illumina NGS system. GeoMx offers a number of advantages as compared to traditional spatial technologies, including the ability to profile both RNA and protein, the ability to multiplex large numbers of different RNA or proteins simultaneously in each selected region, flexibility on the selection of regions to analyze, and the ability to process 10 or more biological samples per day. When GeoMx was first made commercially available, researchers were only able to read out information on up to 96 biological targets from each of their GeoMx-selected regions of interest using nCounter. In August 2020, the company added software capabilities and consumables which enabled GeoMx region of interest data to be read out using Illumina NGS systems, which significantly expanded the number of biological targets researchers could analyze in selected regions. In 2021, the company’s Whole Transcriptome Atlas, or WTA, became commercially available and further expanded the number of biological targets in a GeoMx region of interest that may be read out on NGS systems to approximately 18,000 RNAs. Linking GeoMx with NGS also significantly expands the company’s total potential market opportunity. As of December 31, 2022, there were approximately 23,000 Illumina NGS systems installed globally. GeoMx DSP Instrument and Software The company’s GeoMx DSP instrument uses specialized optics to image slide-mounted biopsies that have been prepared using its GeoMx DSP consumable reagents, as well as with IHC or ISH technology typically available in research or commercial laboratories. GeoMx DSP then allows a researcher to select regions of interest for analysis on screen, and then prepares samples from the selected regions of interest for molecular profiling. Like nCounter, GeoMx is capable of supporting applications including gene expression and protein expression. GeoMx is fully automated and easy to use, requiring only 30 minutes of hands-on time per run and offering the ability to process up to 10 slides per day and is therefore ideal for a range of applications requiring efficient, high-precision, simultaneous quantitation of large numbers of target molecules across a set of biological samples. The GeoMx software enables the integration of the four color images acquired and the corresponding digital counts of the levels of RNA or protein as acquired using the company’s nCounter Analysis System, or an Illumina NGS system. The GeoMx data center uniquely combines system control to visualize whole sample images at single cell resolution with automated or manual region of interest selection. The fully integrated workflow provides tracking of image data and corresponding profiling data, allowing users to easily go from data collection to data analysis. In addition to its internally developed software, in 2020, the company announced a collaboration with Illumina, whereby it has developed a GeoMx application powered by Illumina’s DRAGEN Bio-IT platform in order to facilitate the analysis of data generated by its customers using NGS read out on Illumina systems. GeoMx DSP Consumables The company’s portfolio of GeoMx DSP consumables focuses on RNA and protein profiling for immunology, immuno-oncology and neurobiology applications, targeted either for nCounter read out where a set of genes and a biological pathway may be better understood for more targeted experiments, or for NGS read-out in basic discovery applications where significantly greater numbers of genes may be of interest. GeoMx consumable products are designed as standardized panel products that represent important content for certain disease areas with an option for researchers to add customized content to that panel depending on the area of interest or desired number of targets for analysis. The company’s GeoMx assays generate high-quality results from challenging sample types, including formalin fixed paraffin embedded (FFPE) and crude cell lysates. The company’s significant GeoMx consumable products include: Enabled for nCounter Readout Immuno-Oncology Panels: An immuno-oncology-focused panel menu that comprises up to 96 protein and RNA targets for analyzing the tumor and tumor microenvironment compartments in human and mouse biological samples. The standard, or core, panel offering consists of 18 targets, and researchers have the option of adding over 30 additional targets for analysis focused on specific applications, such as immuno-oncology drug target proteins, or human immune activation proteins, and 23 additional targets for analyzing mouse samples for pre-clinical applications. In addition, the company offers RNA panel content to allow for the analysis of up to 84 targets for human immune pathways. Neurobiology Panels: A neurobiology-focused menu that comprises up to 40 protein targets to profile human neural cells. The standard, or core, panel offering comprises 20 targets, and researchers have the option of adding up to 20 additional targets for analysis focused on specific applications such as proteins implicated in Alzheimer’s disease or Parkinson’s disease. Enabled for NGS readout Targeted Cancer Transcriptome Atlas (CTA): The CTA includes more than 1,800 genes that cover over 100 pathways critical to understanding tumor biology, the immune response and the tumor microenvironment. Biological content can be further customized with the addition of up to 60 user defined targets. The CTA panel is compatible with both fresh frozen and FFPE-embedded biological samples, allowing scientists to work with a broad spectrum of samples in their research. As part of a full end-to-end solution, the company is providing library preparation reagents and next generation sequencer (NGS) readout, a bioinformatics pipeline that links high-resolution, full-slide images generated on GeoMx with the massively parallel output of Illumina sequencers. Universal Protein Assays: The available content covers applications in immuno-oncology and future content releases are planned to cover immunology and neuroscience. These assays will provide GeoMx CTA and WTA users complementary protein content designed for NGS read out. The company’s GeoMx Protein Assays for NGS readout expanded the protein capabilities of GeoMx from tens to hundreds of validated proteins to be analyzed from a single sample section with spatial resolution. Whole Transcriptome Atlas (WTA): The WTA, a GeoMx consumable product that became commercially available for use in human and mouse biological samples during 2021, is a universal panel that provides an unbiased, spatial view of approximately 18,000 RNA targets and is designed to be read out using NGS. The WTA unlocks new pathways to be explored by researchers and is designed to broaden GeoMx RNA profiling from oncology and immunology to include neuroscience, developmental biology and other diverse fields. The WTA assay provides robust and sensitive performance both fresh frozen and FFPE-embedded biological samples, allowing scientists to work with a broad spectrum of samples in their research. WTA utilizes the same workflow and chemistry as the company’s CTA. CosMx SMI The company’s CosMx Spatial Molecular Imager, or CosMx SMI or CosMx, which was made commercially available in December 2022, is designed to combine the spatial profiling of a large number of biological targets with high-resolution imaging, which will allow researchers to both analytically measure, as well as visualize the activity of selected RNA or proteins at the single cell or sub-cellular level. CosMx SMI enables the analysis of up to 1,000 RNA targets or up to 68 protein targets directly from single cells within morphologically intact biological samples and is expected, after further development, to enable the analysis of up to 6,000 RNA targets or up to 120 protein targets. CosMx SMI offers researchers the opportunity to drill down further into regions of interest in biological samples, as a complement to the company’s GeoMx DSP which typically offers gene expression profiling across regions containing multiple cells. CosMx SMI incorporates a proprietary version of the company’s chemistry that was originally developed as part of its concluded collaboration with Lam Research, whereby it modified its core nCounter chemistry to be utilized in a NGS sequencing platform and related assays. Upon the conclusion of its Lam collaboration, in 2020 the company began exploring applications for this newly developed chemistry in spatial biology, specifically whether it could conduct spatial analysis of increasingly smaller regions of interest, down to the individual cell and potentially sub-cellular level. Upon completing proof of principle research and development, the company announced the expected development and commercialization timeline for CosMx SMI in December 2020. The company has designed CosMx SMI to address the unmet need for high-plex spatial analysis at single cell and sub-cellular resolution, which may be ideally suited for targeted applications such as creating cell atlases or studying cell-cell interactions. The company’s GeoMx DSP and CosMx SMI platforms are designed to be synergistic, creating a spatial biology portfolio that spans the continuum from targeted to whole transcriptome analysis, and from multicellular resolution down to single cell and sub cellular applications. CosMx SMI offers a number of advantages as compared to competing imager platforms, including the ability to profile a high number of selected targets or high plex, a larger sample scan area of up to 300 square millimeters, a tunable throughput that allows researchers to process between 2 to 20 samples per week depending on the number of targets selected for study, and the ability to store, manage, analyze and share data from the large data sets generated in a cloud-based informatics environment. CosMx SMI Instrument and Software The company’s CosMx SMI instrument uses specialized optics to perform high-plex analysis at cellular and subcellular resolution of slide-mounted FFPE and fresh frozen, or FF, tissue samples which have been prepared using CosMx Assay Consumables. CosMx SMI allows researchers to select specific fields of view, or FOVs, up to 300 square millimeters and then uses an integrated readout to enable visualization of up to 1,000 RNA, or up to 68 protein targets. Like nCounter and GeoMx DSP, CosMx SMI is capable of supporting applications, including gene expression and protein expression. The CosMx SMI uses standard histology workflows and features semi-automated options to reduce hands-on time per run. CosMx SMI workflows and integrated readout enable researchers to process up to 2 slides per week for 1000-plex RNA assays covering 100 mm2 tissue area or up to 7 slides per week for 68-plex Protein assays covering 100 mm2 tissue area. CosMx SMI uses multi-modal cell segmentation to provide accurate cell boundary detection. This cell segmentation process uses cell membrane and protein morphology images, a machine-learning augmented cell segmentation algorithm and transcript-based segmentation refinement to achieve precise single-cell segmentation results from intact tissue. AtoMx SIP is the supported software platform for CosMx SMI. CosMx SMI is designed to seamlessly export data to AtoMx SIP to enable researchers to visualize, analyze and perform enhanced bioinformatic workflows on their collected results. CosMx SMI Consumables Launched in December 2022, the company’s portfolio of CosMx SMI consumables focuses on RNA and protein profiling for immunology, immuno-oncology and neurobiology applications. CosMx consumable products are designed as standardized panel products that represent important content for certain disease areas with an option for researchers to add customized content to that panel depending on the area of interest or desired number of targets for analysis. The company’s CosMx assays generate high-quality results from challenging sample types, including FFPE and crude cell lysates. The company’s significant CosMx consumable products include: For RNA: Immuno-Oncology Panel: An immuno-oncology-focused panel that comprises 100 RNA targets for analyzing the tumor and tumor microenvironment compartments in human biological samples. The standard, or core, panel offering consists of 100 targets, and researchers have the option of swapping up to 10 targets for custom RNA targets. Neurobiology Panels: A neurobiology-focused menu that comprises up to 1,000 targets to profile mouse neural cells. This panels enables research into topics such as Alzheimer’s disease or Parkinson’s disease. Universal Panels: A universal panel that comprises up to 1,000 RNA targets human biological samples. The Human Universal RNA Panel enables researchers to explore pathways at the single cell and subcellular level and provides robust and sensitive performance for real-world FFPE-embedded biological samples, allowing scientists to work with a broad spectrum of samples in their research. For Protein Immuno-Oncology Panel: In immuno-oncology-focused panel that comprises 64 protein targets for analyzing the tumor and tumor microenvironment compartments in human biological samples. The standard panel offering consists of 64 targets and has demonstrated robust and sensitive performance in real-world FFPE-embedded biological samples. Content releases in 2023 are expected to cover neurobiology content for mouse biological samples and are expected to include an option to customize pre-validated protein panel content with up to 8 custom labeled antibodies through NanoString’s Protein Barcoding Service. AtoMx SIP The company’s AtoMx Spatial Informatics Platform, or AtoMx SIP or AtoMx, is a cloud-based, open source and fully integrated informatics solution for spatial biology. AtoMx, which was commercially launched in December 2022, is initially for use with CosMx, and is expected to be made available for use with GeoMx by the end of 2023. AtoMx enables users to perform image analysis and data visualization and utilize scalable and on-demand cloud computing and data storage, allowing data sharing to enable global research collaboration. AtoMx provides the secure, scalable storage and analysis that spatial biology researchers need to drive their workflow from study design to peer-reviewed publication. AtoMx stores customer data in a flexible data lakehouse structure, which can be examined using artificial intelligence and machine learning approaches. A cloud-based platform reduces or eliminates the need for laboratories to invest in their own costly informatics infrastructure and reduces spatial biology analysis compute times from days to hours. Technology Access Program (TAP) Selected customers can access the company’s GeoMx DSP and CosMx SMI through its in-house Technology Access Program, or TAP, service and may select panels that read out on either nCounter or NGS. Through TAP, customers submit biological samples to the company’s Seattle facilities where they are imaged and profiled using its instruments and once completed, the company provides a detailed report, which includes raw data and analyzed results back to the customer. The company has successfully utilized TAP prior to and during its GeoMx DSP and CosMx SMI instrument and product commercial launches and it may be a leading indicator of potential future commercial demand for its products. nCounter The company’s nCounter Analysis System is an automated, multi-application, digital detection and counting system which directly profiles hundreds of molecules simultaneously, using its proprietary optical barcoding chemistry that is powerful enough for use in research, yet simple enough for use in clinical laboratories. The company’s nCounter Analysis System is based on automated instruments that prepare and analyze biological samples using proprietary reagents which can only be obtained from it. The company’s research and clinical laboratory customers purchase instruments from it and then purchases its reagents and related consumables for the specific experiment they wish to conduct and for tests that they intend to run, respectively. The company’s nCounter Analysis System is capable of supporting a number of applications, including gene expression, protein expression, gene mutation, miRNA expression, copy number variation, gene fusions and molecular diagnostics. The company’s nCounter Analysis System offers a number of advantages, including providing a simpler and faster workflow with minimal hands-on time for multiplex analysis of up to 800 RNA, or protein targets. Additionally, because nCounter is fully automated and easy-to-use, it is ideal for a range of applications requiring efficient, high-precision, simultaneous quantitation of hundreds of target molecules across a set of biological samples. The company’s nCounter assays generate high-quality results from challenging sample types, including FFPE and crude cell lysates. nCounter Instruments The company offers three versions of its nCounter Analysis System, each targeted at a distinct user segment. The company’s nCounter Pro is a higher throughput instrument with features appealing to larger core laboratories serving multiple researchers. The company’s nCounter SPRINT Profiler is designed to appeal to individual researchers running relatively smaller experiments. The company’s nCounter FLEX, which is targeted toward clinical laboratories, has been 510(k) cleared by the U.S. Food and Drug Administration, or FDA, and CE marked by European regulatory authorities. The nCounter FLEX system was designed and is manufactured under ISO 13485:2003, the quality standard for in vitro diagnostic platforms and medical devices. nCounter FLEX is enabled to run the Prosigna breast cancer assay, as well as other proprietary or laboratory developed tests, or LDTs that may be developed. Pursuant to the terms of its License and Asset Purchase Agreement, or LAPA, with Veracyte, Inc., or Veracyte, the company granted to Veracyte an exclusive worldwide license to its nCounter FLEX system for in vitro diagnostic use and for the development and commercialization of in vitro diagnostic tests on the nCounter FLEX system and sold to Veracyte certain assets, including its rights with respect to the Prosigna breast cancer assay. The nCounter Pro and FLEX systems comprise a Prep Station and a Digital Analyzer. The Prep Station is the automated liquid handling component that processes and prepares the samples for data collection on the Digital Analyzer. The Digital Analyzer collects data from samples by taking images of the immobilized fluorescent reporters in the sample cartridge and processing the data into output files, which include the target identifier and related count numbers along with a broad set of internal controls that validate the precision of each assay. The nCounter Pro and FLEX throughput can be quadrupled using sample multiplexing for experiments targeting 200 genes or fewer. The nCounter SPRINT Profiler combines the liquid handling steps and the digital analysis through use of a special microfluidic cartridge. nCounter Consumables The majority of the company’s nCounter consumables sold are standardized off-the-shelf panel products that represent important gene signatures for certain disease areas. nCounter consumables can also be customized to a specific set of genes at a customer’s request. Panels The company offers more than 50 gene expression panels for use with a broad range of sample types and species, including human, mouse, non-human primate- and other. These pre-manufactured panels contain highly-curated, thematic gene content built in collaboration with the scientific community. nCounter pre-built panels are also customizable to address specific research interests with the purchase of the company’s custom Panel Plus product, allowing for up to 55 additional user defined genes to be added to any off-the-shelf-panel. Custom CodeSets The company works with its customers to design and develop custom gene expression CodeSets to enable them to evaluate specific genes that are the subject of their study. The company’s customers provide it a list of targets for which it subsequently build a unique CodeSet to their specifications. The company’s design process leverages full length sequences for the RNA molecules that its customers are interested in detecting and prevents cross hybridization to non-target molecules in the sample. The custom CodeSet design process occurs in four distinct steps: the customer selects the genes of interest, it designs probes and provides a design report to the customer,the customer reviews and approves the design report and it manufactures, tests and ships the CodeSet to the customer. nCounter Software and Data Analysis nCounter instrument platforms also include the company’s nSolver Analysis Software and nCounter Advance Analysis add-on to nSolver, providing an integrated data analysis program that offers researchers the ability to quickly and easily quality check, normalize and analyze their data without having to use any additional software for data analysis. The FLEX system, in addition to running any of the company’s research applications, can also be enabled with software that runs Prosigna to generate individualized patient reports. In May 2020, the company announced a collaboration with ROSALIND Bioinformatics, a provider of cloud-based genomic analysis tools, for the development of new analysis tools for data generated on its nCounter Analysis System. ROSALIND offers a cloud-based platform that connects researchers to differential expression and pathway exploration in a real-time collaborative environment. Functionality has been built into ROSALIND’s cloud-based analysis suite that facilitates nCounter data visualization, exploration and collaboration. These new capabilities were offered immediately through early access to COVID-19 researchers performing critical host response studies on the company’s nCounter platform. In 2021, ROSALIND created a unique data analysis solution specific to the nCounter TCR Diversity Panel, which is routinely utilized to profile T-cell receptor variable and constant regions and other T-cell markers, resulting in a TCR Diversity Score. The company is working with ROSALIND to make certain features of nSolver available within ROSALIND, and it is evaluating opportunities for joint development of new analysis solutions. Molecular Diagnostics The company’s nCounter Analysis System has the precision, reproducibility and simple workflow required of technologies used in clinical laboratories. Clinical laboratory customers use the nCounter Analysis System and the company’s Prosigna breast cancer assay to provide clinical diagnostic services. Prosigna is based on a collection of 50 genes known as the PAM50 gene signature, which was discovered by several of the company’s research customers. Prosigna can provide a breast cancer patient and physician with a subtype classification based on the fundamental biology of the patient’s tumor, as well as a prognostic score that indicates the probability of cancer recurrence over 10 years. Physicians use Prosigna to help guide therapeutic decisions so that patients receive a therapeutic intervention, such as chemotherapy, only if clinically warranted. In September 2013, the company received 510(k) clearance from the FDA to market in the United States a version of Prosigna providing a prognostic indicator for distant recurrence-free survival at 10 years. In December 2019, the company entered into an exclusive license of nCounter diagnostic assets and rights to Veracyte, Inc., or Veracyte. License Agreements The company’s molecular barcoding chemistry technology is in-licensed from the Institute for Systems Biology. In addition, the company has licensed technology related to its diffuse large B-cell lymphoma, or DLBCL, assay from the National Institutes of Health, and it relies on other license and supply arrangements for proprietary components which require it to pay royalties on the sale of its products. Veracyte, Inc. In December 2019, the company entered into a LAPA and Service and Supply Agreements, or SSAs, with Veracyte. Pursuant to the LAPA, the company completed a license of intellectual property and a sale of certain assets to Veracyte relating to its nCounter FLEX system for use in clinical diagnostic applications. Veracyte also acquired certain intellectual property rights and worldwide distribution rights relating to Prosigna and its LymphMark assay, and certain clinical diagnostic assay software modules that operate with the nCounter FLEX system. Pursuant to the LAPA, the company provided Veracyte a worldwide exclusive license to market and sell clinical diagnostic tests developed for its nCounter FLEX platform for in vitro diagnostic use and for the development and commercialization of in vitro diagnostic tests, including in vitro diagnostic devices or laboratory developed tests, for use on the nCounter FLEX platform. In connection with the transaction, Veracyte agreed to assume certain liabilities associated with the assets purchased under the LAPA, including ongoing third-party royalty obligations relating to Prosigna and LymphMark. The company also assigned to Veracyte its Amended and Restated Exclusive License Agreement with Bioclassifier, LLC, effective July 7, 2010, as amended, which granted rights to certain intellectual property related to Prosigna. The company also entered into a sublicense agreement with Veracyte relating to the Bioclassifier Agreement wherein it obtained certain non-exclusive rights relating to its rights to provide Prosigna to Veracyte on an ongoing basis and for other research or investigational purposes. Pursuant to the SSAs, the company agreed to supply to Veracyte nCounter FLEX systems, and to manufacture and supply Prosigna kits, LymphMark kits and any additional clinical diagnostic tests that Veracyte may develop in the future for nCounter, for a period of at least four years subsequent to the transaction date. Pursuant to the SSAs, Veracyte will pay the designated transfer prices for nCounter FLEX systems, Prosigna kits, LymphMark kits and any other nCounter-based diagnostic tests developed by Veracyte. Lam Research Corporation In August 2017, the company entered into a collaboration agreement with Lam Research Corporation, or Lam, to develop a NGS sequencing platform and related assays. Institute for Systems Biology In 2004, the company entered into an agreement with the Institute for Systems Biology pursuant to which the Institute granted to it an exclusive, subject to certain government rights, worldwide license, including the right to sublicense, to the digital molecular barcoding technology on which its nCounter Analysis System is based, including 13 patents and patent applications. Pursuant to the terms of the amended license agreement, the company is required to pay the Institute for Systems Biology royalties on net sales of products sold by it, or its sublicensees, at a low single digit percentage rate, which was reduced by 50% in the third quarter of 2016 for the remainder of the license term due to the achievement of a cumulative sales threshold. Intellectual Property As of December 31, 2022, the company owned or exclusively licensed approximately 38 issued U.S. patents and approximately 21 pending U.S. patent applications, including provisional and non-provisional filings and 5 pre-nationalization PCT applications. The company also owned or licensed approximately 312 pending and granted counterpart applications worldwide, including 123 country-specific validations of 17 European patents. The issued U.S. patents that the company owns or exclusively licenses are expected to expire between September 3, 2024 and November 21, 2037. The company has either sole or joint ownership positions in all of its pending U.S. patent applications. For its material nCounter Analysis System the company is the exclusive licensee. The company’s patent applications generally relate to the following main areas: Its GeoMx DSP, CosMx SMI, or nCounter Analysis System biology, chemistry, methods, analytics and hardware; specific applications for its GeoMx DSP, CosMx SMI, or nCounter Analysis System technology; its gene expression markers, methods and gene signatures for recurrence and drug response in certain forms of cancer; methods and systems for the processing and analysis of spatial profiling and sequencing data; biological and chemical compositions, methods and hardware for enzyme- and amplification- free sequencing; and biological and chemical compositions, methods and hardware for multiplexed detection and quantification of protein and/or nucleic acid expression in a defined region of a tissue or cell. Sales and Marketing The company began selling nCounter to researchers in 2008, GeoMx DSP in 2019, and CosMx SMI and AtoMx SIP in 2022. The company sells its nstruments and related products primarily through its own sales force in North America and through a combination of direct and distributor channels in Europe, the Middle East, Asia Pacific and South America. The company has agreements with 44 distributors, each of which is specific to a certain territory. In the event a distributor does not meet minimum performance requirements. Manufacturing and Suppliers Instruments Precision System Science, Co., Ltd. of Chiba, Japan, or PSS, is the company’s sole source supplier for the nCounter Prep Station. Korvis Automation Inc., or Korvis, is its sole source supplier for its nCounter Digital Analyzers and its GeoMx DSP instrument at its facility in Corvallis, Oregon. Paramit Corporation, or Paramit, is the company’s sole source supplier for its nCounter SPRINT Profiler at its facility in Morgan Hill, California. D&K Engineering, Inc. of San Diego, California is its sole source supplier of its CosMx SMI instrument. Consumables For example, Cidra Precision Services, LLC, of Wallingford, Connecticut, part of IDEX Health & Science, is the sole supplier of the microfluidic cartridge for the company’s nCounter SPRINT Profiler. Software The company has expanded its information technology engineering, data management and monitoring capabilities to support the launch of AtoMx, including establishing a Network Operations Center in its greater Seattle facilities. Competition In the life sciences research market, the company competes with companies, such as Agilent Technologies, Akoya Biosciences, Bio-Rad, Bio-Techne, Standard BioTools, Illumina, Qiagen, Thermo Fisher Scientific, Vizgen and 10x Genomics. Research and Development Expense The company’s research and development expenses totaled $70.8 million in 2022. Government Regulation of Products The company’s nCounter FLEX, which is targeted toward clinical laboratories, has been 510(k) cleared by the FDA. The nCounter FLEX was designed and is manufactured under ISO 13485:2016 and the QSR, 21 CFR Part 820, the current quality standards for in vitro diagnostic platforms and medical devices. In December 2019, the company entered into a License and Purchase Agreement, or LAPA, and Service and Supply Agreements, or SSAs, with Veracyte. Pursuant to the LAPA, it completed a license of intellectual property and a sale of certain assets to Veracyte relating to its nCounter FLEX for use in clinical diagnostic applications. Veracyte also acquired certain intellectual property rights and worldwide distribution rights relating to Prosigna and its LymphMark assay, and certain clinical diagnostic assay software modules that operate with the nCounter FLEX. Pursuant to the LAPA, the company provided Veracyte a worldwide exclusive license to market and sell clinical diagnostic tests developed for its nCounter FLEX for in vitro diagnostic use and for the development and commercialization of in vitro diagnostic tests, including in vitro diagnostic devices or LDTs, for use on the nCounter FLEX. The company’s nCounter FLEX has been CE-marked in the EU, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be marketed through the EU and European Economic Area member states. Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to market medical devices. History NanoString Technologies, Inc. was founded in 2003. The company was incorporated in Delaware in 2003.