NanoString on Track to Launch Breast Cancer Subtyping Test in EU with CE Mark, in US with FDA OK | GenomeWeb

After establishing a new diagnostics unit in May, NanoString Technologies is planning to launch its flagship Breast Cancer Intrinsic Subtyping Assay in European markets with CE marking by year end and in the following 12 months file a 510(k) application with US regulators.

Nearly three months ago, NanoString launched a diagnostics division to commercialize its flagship Breast Cancer Intrinsic Subtyping Assay, as well as other tests that can help doctors tailor drugs and treatment strategies to molecularly defined patient populations.

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