A developer of molecular diagnostics and provider of life science tools for translational research, NanoString Technologies, has announced the initiation of the first study which will be followed by further studies to assess the clinical application of its breast cancer intrinsic subtyping assay which is solely based on the PAM50 gene signature.
The nCounter analysis system of NanoString
The primary investigation will use TransATAC study samples to test the capability of the assay to measure the possibility of cancer reoccurrence in women undergoing post-menopause having hormone receptor-positive, early stage breast cancer (ESBC) after undergoing hormonal therapy.
The translational study group, TransATAC has utilized the data and tissue from Arimidex, Tamoxifen, Alone or as a Combination (ATAC) trial to analyze the molecular characteristics of cancer cells in ESBC patients. The PAM50 gene signature offers a subtype classification called intrinsic subtyping which is based on the fundamental history of a person’s breast tumor. This intrinsic subtyping can be utilized to obtain a prognostic score.
The medical developmental program for breast cancer intrinsic subtyping assay was designed in order to support its integration into breast cancer therapeutic procedures and clinical regulatory clearance.
After receiving regulatory approvals, NanoString desires to make available, its Breast Cancer Intrinsic Subtyping assay on the nCounter platform to global medical centers and pathology laboratories. The nCounter is a completely automated digital counting and detection analysis system with an extremely simple process-flow. All the consumables and reagents needed to perform the experiment are present in the assay kits. Its capability to test small samples and its adaptability with different types of samples such as paraffin-embedded, formalin-fixed tissue enables the system to be applicable for analyzing several problems arising in translational medicine. Apart from gene expression assays, the company offers assays for miRNA analysis and copy number variation. At present, the nCounter system is available only for research purposes.