NanoString Technologies was founded in 2003 to develop a technology to detect and count large sets of target molecules in biological samples. Headquartered in Seattle, Washington, the company employs about 90 people and has raised more than $47 million since it was founded. NanoString Technologies launched its first commercial instrument, the nCounter Analysis System, in 2008.

The system is based on digital molecular barcoding technology invented at the Institute for Systems Biology in Seattle. Each color-coded barcode is attached to a single target-specific probe that corresponds to a gene of interest. The barcode-labeled probes anneal directly to mRNAs in solution, and the hybrid molecule is then immobilized. Single molecular imaging detects and counts hundreds of unique transcripts in a single reaction, forming a multiplexed assay for specific applications including gene expression analysis, miRNA analysis and copy number variation detection.

A frustration with assays prompted the system’s development, according to NanoString CEO Brad Gray. Assays can present challenges such as complicated workflows, low accuracy and the minimal amounts of starting material required. Unlike microarray- or PCR-based gene expression analysis technologies, the nCounter Analysis System does not use synthesis of a cDNA strand or PCR amplification. This eliminates the need for enzymatic reactions, which can introduce bias. The system can currently assay up to 800 gene targets per reaction. Sensitivity is comparable with qPCR systems, but less than 15 minutes of hands-on time per reaction is required, said Mr. Gray.

NanoString’s goal, explained Mr. Gray, is to take gene signatures identified by the research community, clinically validate them and submit them for FDA approval as in vitro diagnostic (IVD) devices. Oncology is the company’s initial focus. In 2010, the company announced it had licensed the PAM50 gene signature from Bioclassifier, which is a partnership of four researchers. The license will be used to develop NanoString’s first IVD product for intrinsic subtyping of breast cancer. The assay will be able to measure the expression levels of 50 genes in formalin-fixed, paraffin-embedded breast tumor tissue samples. In the future, Mr. Gray told IBO, NanoString may also consider opportunities in immunology and infectious diseases.

The nCounter technology provides a solution for the transition of research findings from discovery to diagnostics, explained Mr. Gray, with many of NanoString’s research customers bringing content to the company with the goal of commercializing it as a diagnostic test. Researchers enter into license agreements with NanoString because they want a technology platform to utilize the potential of, for example, a discovered gene signature and are not interested in developing or optimizing the technology themselves.

The company is also pursuing testing in multiple settings. “We believe that our technology will enable a new distributed model that has the potential to change the delivery of these kinds of tests,” said Mr. Gray. “Bringing the testing closer to the point of care with a distributed model would put the practitioners and pathologists back in charge of handling diagnostic testing, something they have been asking for.”