The European Union (EU) has granted a CE quality mark to NanoString Technologies’ PAM50-based gene expression test for breast cancer.
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 breast tumour.
The test also offers a prognostic score that predicts the probability of cancer recurrence over ten years in post-menopausal women with hormone receptor-positive early stage breast cancer (ESBC), according to the company.
NanoString Technologies president and chief executive officer, Brad Gray, said: "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 that can be done in local laboratories in countries that recognise the CE mark."
The award was based on positive results from the company’s first clinical validation study which included more than 1,000 samples from the TransATAC study, and the 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 programme.
"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 recognising the CE mark in early 2013.