BioClassifier has granted NanoString Technologies an exclusive worldwide license to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping based on the Bioclassifier PAM50 gene signature. NanoString will develop a test to measure expression of the 50 gene signature in FFPE breast tumor samples on its digital nCounter® Analysis System.
The nCounter platform has been developed as a fully automated technology for the detection and quantitation of large sets of target molecules in biological samples. The complete system comprises the instrumentation, CodeSets/Kits, and reagents/consummables required to carry out multiplexed digital target profiling across a range of applications, including gene expression, miRNA, and copy-number variant analysis, NanoString claims. The platform involves simple sample-preparation steps and protocols, and requires no amplification. Instead, color-coded molecular barcodes hybridize directly to target molecules.
The firm hopes the NanoString Breast Cancer Intrinsic Subtyping Assay will represent the first in a series of molecular diagnostic assays it aims to commercialize as in vitro diagnostic products for hospital and pathology laboratories.
“We had a goal to translate our decade of work on the intrinsic subtypes into a distributed test that could help breast cancer patients around the globe,” comments Charles Perou, Ph.D., Bioclassifier co-founder and professor of genetics and pathology at the University of North Carolina at Chapel Hill. “We believe NanoString is the partner with the ideal technology to bring gene-expression profiling into the clinical setting.The technology is robust and reproducible, works with the sample types routinely used in clinical practice, and is the simplest digital counting technology available.
“Intrinsic subtyping has entered the lexicon of breast cancer researchers and oncologists alike,” adds Bioclassifier co-founder Matthew Ellis, M.D., who directs the Breast Cancer Program at the Washington University School of Medicine at St. Louis. “Upon validation and regulatory approval, we believe this gene-expression panel will become part of the standard of care for breast cancer diagnosis and treatment, and will be useful in the evaluation of all newly diagnosed breast cancer patients.”
NanoStrings already offers nCounter kits and CodeSets for gene expression, miRNA, and copy-number variant analysis. Its flagship gene-expression CodeSets enable users to analyze the expression of up to 800 genes simultaneously, with sensitivity comparable to qPCR, it claims. Analysis can be carried out on tissue and blood lysates as well as FFPE extracts, with just 15 minutes of hands-on time per reaction.
The nCounter Human miRNA Expression Assay Kit, launched in April, allows accurate discrimination between miRNAs at single-base resolution, NanoStrings claims. Each CodeSet contains a comprehensive collection of over 700 human and viral miRNAs derived from miRBase, in a single, highly multiplexed assay. Newly discovered miRNAs can also be added, to keep the CodeSets up-to-date, the firm adds.
In November NanoString launched its CNV application for the nCounter system. It says the CNV CodeSets enable researchers to perform the functional equivalent of 9,600 qPCR reactions (800 regions across 12 samples) with only 25 minutes of hands-on time. This equates to the ability to assay up to 800 loci in a single tube, with as little as 300 ng of starting material.