Prosigna Breast Cancer Prognostic Gene Signature Assay : 92125

Message
The following information must be provided by the client:
1. Specimen Source
2. Number of Positive Nodes
3. Tumor size


Test Code
PRBC or 92125


Alias/See Also
PAM50 algorithm-based Risk of Recurrence Score


CPT Codes
81520

Instructions
Formalin-fixed, paraffin-embedded tissue. Alternative Specimen: 6 unstained 10-micron slides.


Transport Container
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). Surgical pathology report required.


Transport Temperature
Ambient.


Specimen Stability
Ambient: Indefinite; 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, Tumor size <4 mm2


Methodology
Hybridization/gene expression

Setup Schedule
Varies


Report Available
12-14 days (From receipt at performing laboratory)


Reference Range
By report.


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+) invasive breast cancer. Useful in both node-negative and node-positive (1-3 nodes) disease.


Performing Laboratory
Quest Diagnostics



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.