NanoString Technologies received a CE mark for its PAM50-based gene expression test for breast cancer. The assay, run on the firm’s nCounter® analysis system, provides subtype classification of an individual breast cancer, together with a prognostic score that indicates the 10-year likelihood of breast cancer recurrence in post-menopausal women with hormone receptor-positive, early-stage disease who have received hormone therapy.
Currently available in the U.S. for research use only, the newly CE-marked NanoString assay is based on the PAM50 50-gene signature that is used to classify breast cancers into the four subtyptes; luminal A, luminal B, Her2-enriched, and basal-like. The firm holds a worldwide license to the PAM50 gene signature for the development of in vitro diagnostic and research products for breast cancer on its Counter® Analysis System. Certification in Europe was based on positive data from NanoString’s clinical validation study and a recently completed multisite analytical validation study, which included over 1,000 samples from the TransATAC study of postmenopausal women with hormone receptor-positive early-stage breast cancer.
“PAM50 on the nCounter platform represents the next generation in genomic testing for breast cancer, providing a powerful new tool for reliable and accurate genomic testing,” comments Brad Gray, president and CEO at NanoString. “This regulatory filing is an important milestone in NanoString’s vision to support the global democratization of genomic testing, and make high-impact gene profiling tests widely available as in vitro diagnostic products.”
The firm says approval of the test has been achieved just two years after it started clinical development. “This filing comes right on the heels of the landmark study from The Cancer Genome Atlas that demonstrated the power of the PAM50 for subtyping breast cancer into four diseases,” adds Bruce Seeley, svp and general manager for Diagnostics at NanoString.
The firm’s fully automated nCounter platform uses single-molecule imaging and a digital color-coded barcode technology based on direct multiplexed measurement of gene expression to detect and count potentially hundreds of unique transcripts in a single reaction, without the need for amplification. The firm’s current portfolio of application-specific solutions includes kits for gene expression, copy number variation, and miRNA analysis.