Prosigna® Breast Cancer Prognostic Gene Signature Assay
Also known as: PAM50 Risk of Recurrence Score
Use
The Prosigna® assay provides a prognostic gene signature for breast cancer, reporting a 10-year risk of distant recurrence, risk classification, lymph node involvement, tumor size, and proliferative subtype. It is used to guide therapeutic decisions in early-stage breast cancer by assessing the likelihood of disease recurrence and intrinsic subtype profile. Genetic expression of the PAM50 (Prosigna) signature and tumor clinicopathologic features are integrated to inform risk stratification.
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
Other
Biomarkers
LOINC Codes
- 31208-2 - Specimen source
- 76544-6 - Brst ca 10Y dist recur score Prosigna
- 76545-3 - Brst ca 10Y dist recur class Prosigna
- 76397-9 - LN involved LN Ql
- 21889-1 - Size Tumor
- 49549-9 - Ref lab test method
- 74019-1 - Probability of disease
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
FFPE tissue block or unstained slides
Collection Instructions
Formalin-fixed, paraffin-embedded tumor tissue block or at least 6 unstained 10‑micron slides (minimum 3 slides)
Storage Instructions
Room temperature or refrigerated; ship in cooled container during summer months
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
Other tests from different labs that may be relevant