Breast Cancer Prognostic Gene Signature Assay (Prosigna®), IVD
Also known as: Prosigna®
Use
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.
Special Instructions
The test requires the gross size of the tumor and nodal status to be known. A copy of the original pathology report is mandatory for processing. The assay is intended solely for FFPE specimens from surgical resections and not for needle biopsy samples or other fixatives. Specimens with more than four positive nodes or micrometastases are not suitable. Detailed instructions and information are required from the ordering provider to prevent delays in testing.
Limitations
The Prosigna® assay is optimized for RNA extracted from FFPE breast tissue, with its performance validated specifically for postmenopausal women with hormone receptor-positive early-stage breast cancer treated with five years of adjuvant endocrine therapy. The assay is unsuitable for patients outside this group or those with multifocal tumors, as these should be treated as independent tumors. RNA of poor quality or quantity can lead to assay failure, and interfering substances like genomic DNA or non-tumor tissue can affect results. Performance in other regimens or populations, and with different RNA specifications, has not been established.
Methodology
Microarray
Biomarkers
LOINC Codes
- 76546-1
- 21889-1
- 76397-9
- 76545-3
- 74019-1
- 62364-5
- 49549-9
- 72486-4
- 8100-0
- 51969-4
Result Turnaround Time
7-11 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
As many as six unstained slides at 10 µM and one matching H&E-stained slide or FFPE tissue block
Minimum Volume
Not provided
Container
Slides, blocks
Collection Instructions
Submit at room temperature. Indicate date and time of collection on the test request form.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Tumor block containing insufficient tumor; broken or stained slides; core needle biopsy; DCIS specimen; specimen with four or more positive nodes; fresh, frozen, or nonbreast cancer tissue