NanoString Technologies (NSTG) offers nCounter Analysis Systems that are automated, multi-application, digital detection, and counting systems. It provides nCounter MAX and FLEX systems that include nCounter Prep Station, an automated liquid handling component that processes and prepares samples for data collection; and nCounter Digital Analyzer, which collects data from samples through the images of the immobilized fluorescent reporters in the sample cartridge and processing the data into output files. The company also offers the nCounter SPRINT Profiler, an instrument that provides liquid handling steps and the digital analysis through use of a microfluidic cartridge; and nSolver Analysis Software, a data analysis programme that enables researchers to check, normalize, and analyze their data and offers training in data analysis on the nSolver Software. In addition, it provides custom CodeSets; and Pan Cancer pathways gene expression panels, including pathways, immune profiling, and progression panels, as well as nCounter Vantage 3D, other gene expression, miRNA expression, and cancer copy number variation panels. Further, the company offers nCounter Elements reagents that allow users to design customized assays for gene expression, copy number variation, and gene fusions; Master Kits, which include ancillary reagents and plastic ware to setup and process samples in the nCounter Prep Station and nCounter Digital Analyzer; and nCounter Dx Analysis System. The latest development comprises 3D Biology, in which molecules on DNA, RNA and protein level can be counted from the same sample. Operational business is controlled and managed via the headquarters in Seattle, USA.
NSTG’s experience in biomarker development is reflected by the fact that the company obtained CE Mark in September 2012, and FDA 510(k) clearance in September 2013, for the Prosigna™ Breast Cancer Assay representing the initial offering in the molecular diagnostics market.
In 2014 NSTG entered into Biomarker Companion Diagnostic Collaboration with Celgene Corporation to support development of REVLIMID® as treatment for patients with Diffuse Large B-Cell Lymphoma and will develop a companion diagnostic assay using the nCounter® Analysis System to support the clinical validation of REVLIMID® for treatment of Diffuse Large B-Cell Lymphoma (DLBCL).
In 2015 NanoString Technologies and Merck Pharmaceuticals started companion diagnostic collaboration, in which they are evaluating a gene expression-based assay, using NanoString’s nCounter technology, to predict response to Merck’s anti-PD1 immunotherapy Keytruda (pembrolizumab). In 2017, Tumor Inflammation Signature, a gene expression assay looking at 18 markers for immune system response to a tumor, was developed. Nanostring’s newest platform development is the GeoMX Digital Spatial Profiler (GeoMx DSPTM) Analysis system, which will be commercially available in 2019. DSP will enable the analysis of muliplexed multianalyte spatially resolved quanitifaction. Enabling the elucidation of morphological context and high-plex protein or RNA expression data from just one FFPE slide. Enabling the analysis of up to 1000 protein or RNA targets with spatial context, with non-destructive processing. From 2017 NanoString have continued to commercially launch highly relevant multiplexed panels for an increasing number applications including, CAR-T, Autoimmunity, Neuroinflammation and Neuropathology, Tumour microenvironment and Immune Profiling for Breast Cancer and Solid Tumour investigative applications.
In addition to continuing to extend the applications for the nCounter system in the discovery, target validation and routine testing segments of the genomics research market, the company’s goal is to become the platform of choice for diagnostic testing based on multiplexed gene signatures that can be offered in hospitals and pathology laboratories worldwide, following appropriate regulatory approvals. These two synergistic areas of business focus provide researchers with a seamless transition from discovery to diagnostics. The equipment for 3D biomarker development is up and running at the nCounter Core Facility in Heidelberg and nanoString has successfully developed biomarker panels in the past as outlined above. All necessary instruments for quality control and detection of relevant molecules on RNA, DNA, protein level is established at the nCounter Core Facility and probe design as well as antibody labelling for the 3D biomarker panels will be performed at NSTG.
Institute of Human Genetics Website: www.ncounter.uni-hd.de
nanoString website: http://www.nanostring.com/community/core_labs
iLab website: https://hmls.corefacilities.org/service_center/show_external/3574?name=ncounter-core-facility