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Prosigna is 510(k) cleared and CE marked. Prosigna is available to healthcare professionals in the United States, in markets that recognize the CE mark, and/or in which Prosigna is registered.
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Now included 4 Clinical Practice Guidelines

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Prosigna is indicated for use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or Stage II), or node-positive (Stage III) breast cancer to be treated with adjuvant endocrine therapy.
Prosigna Package Insert
Prosigna MSDS
Prosigna product data sheet

Prosigna Product Data Sheet

nCounter User Manual

User Manual