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European Approval Granted for Breast Cancer Gene Test

Mammogram (


NanoString Technologies Inc. in Seattle, a developer of genetic medical diagnostics, received a CE mark noting regulatory approval in Europe for its PAM50-based gene expression test for breast cancer. The CE mark, an acronym for the French Conformité Européene, indicates a product meets safety, health, and environmental protection requirements in the 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

The PAM50 test provides a subtype classification reflecting the biology of an individual’s breast tumor, as well as a prognostic score that predicts the probability of cancer recurrence over 10 years. The test is designed for post-menopausal women with hormone receptor-positive, early stage breast cancer who have been treated with hormonal therapy. Nanostring says the information generated by the test has been shown to convey valuable information about a patient’s prognosis that can help make decisions about a course of therapy.

The company says it has a worldwide license for the PAM50 gene signature to develop lab diagnostic and research products for breast cancer on its nCounter system. The nCounter technology uses unique molecular identifiers, like bar codes, and single molecule imaging to detect and count hundreds of unique transcripts. Each bar code is attached to a single target-specific probe corresponding to a gene of interest.

NanoString says the CE mark was granted based on results from a clinical validation study that showed the PAM50 tests provide more prognostic information than other common tests. The study analyzed more than 1,000 samples from a landmark study of hormone receptor-positive early stage breast cancer.

NanoString plans to begin marketing its breast cancer test in markets covered by the CE Mark in early 2013. The test is still considered investigational in the U.S., where the nCounter technology remains limited to research use only.

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