Prosigna® Breast Cancer Prognostic Gene Signature Assay

The Prosigna® breast cancer prognostic assay is an FDA 510(k)-cleared assay that provides a risk category and numerical score to assess a patient's risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. The Prosigna® assay measures gene expression levels of RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

The gross size of the patient's primary tumor and nodal status are required to perform the assay. A copy of the original pathology report is required for testing. If a pathology report is not received with the sample, testing will be delayed. Please direct any questions regarding this test to customer service at 800-345-4363. Note the following:

1. Performance characteristics of the Prosigna Assay have been established for postmenopausal women with receptor positive early stage breast cancer treated with 5 years of adjuvant endocrine therapy. Performance with other treatment regimens or in other patient populations has not been established.

2. The Prosigna® assay is not intended for patients with four or more positive nodes.

3. Micrometastases were not considered node-positive during the Prosigna® validation, so they should be considered as negative nodes.

4. Only invasive breast carcinoma is qualified for the Prosigna® assay. DCIS (ductal carcinoma in situ) is not qualified for the Prosigna® assay.

5. The Prosigna® assay is intended for use only on formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens from surgical resections. It is not intended for use on needle biopsy samples or fresh, frozen, or nonbreast cancer tissue.

6. Multifocal breast tumors should not be combined. Each should be considered an independent tumor.

Prosigna® is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients. Performance characteristics of the Prosigna® assay have been established for postmenopausal women with hormone receptor-positive early stage breast cancer treated with five years of adjuvant endocrine therapy. Performance with other treatment regimens or in other patient populations has not been established. The interpretation of Prosigna® assay results (Prosigna® Score, risk category) should be evaluated within the context of other clinicopathological factors, the patient's medical history, and any other laboratory test results.

The Prosigna® assay is performed on RNA isolated from FFPE breast tumor tissue. It simultaneously measures the expression levels of 50 genes used in the PAM50 classification algorithm, eight housekeeping genes used for signal normalization, six positive controls, and eight negative controls in a single hybridization reaction, using nucleic acid probes designed specifically for those genes. Prosigna® is a registered trademark of NanoString Technologies Inc.