NanoString Technologies has gained rights to market its PAM50-based gene expression test for breast cancer in the European Union and other countries recognizing the CE mark.
The test, which runs on the company’s nCounter analysis system, provides a subtype classification of breast cancer based on the intrinsic subtyping of an individual’s breast tumor.
The company said Prognostic score that predicts the probability of cancer recurrence over 10 years in post-menopausal women with hormone receptor-positive early stage breast cancer (ESBC) will also be provided.
The approval was based on positive results from the company’s first clinical validation study which included more than 1,000 samples from the TransATAC study as well as recently completed multi-site analytical validation study.
NanoString Technologies diagnostics senior vice president and general manager Bruce Seeley said the company has completed the first regulatory filing of PAM50-based diagnostic test in less than two years after beginning its rigorous clinical development program.
"Women and their clinicians in countries that accept the CE Mark will soon have a new option for informing important treatment decisions, and for bringing more certainty to those decisions," Seeley added.
"This filing is 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 distinct diseases, and importantly the clinical use of intrinsic subtyping is already included in the St. Gallen International Breast Cancer Treatment Guidelines."
The company is planning to start marketing its breast cancer testing kit in the EU and other countries recognizing the CE mark in early 2013.