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Prosigna® Breast Cancer Prognostic Gene Signature Assay
Test Code92125
CPT Codes
81520
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue submitted in IHC specimen transport kit
Other Acceptable Specimens
6 unstained 10-micron slides in tissue transport kit
Instructions
Formalin-fix (10% neutral buffered formalin) and paraffin embed excised tissue. Protect from excessive heat. Transport tissue block or 6 unstained 10-micron slides (minimum: 3 slides). Transport block(s) and/or slide(s) in a tissue transport kit (recommended but not required). Surgical pathology report required.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable
Refrigerated: Indefinite
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens fixed/processed in alternative fixatives • (alcohol, Prefer) • Decalcified specimens • Needle core biopsy • <10% tumor
Methodology
Hybridization/gene expression
Setup Schedule
Set up: Varies; Report available: 12-14 days
Clinical Significance
Assess the risk of distant recurrence in post-menopausal women with early stage (stage I or stage II), hormone receptor-positive (ER+ and/or PR+) breast cancer. Useful in both node-negative and node-positive (1-3 nodes) disease.
