Breast Cancer Prognostic Gene Signature Assay


Sunquest Code:PRSIGCoPath Code:PROSIG
Order Instructions:In Epic, order Prosigna Breast Cancer Prognostic Paenl. Use Epic Code O30400082 for inpatient and O30400083 for ambulatory patients.
Methodology:Gene expression
CPT Code:----------CPTCODES HERE----------
Turnaround Time:Performed Mon-Fri; results are reported within 10-14 days.
Special Instructions:An insurance authorization (faxed) and signed informed consent in the patient's medical record is required; the consent should not be sent to the laboratory. See Associated Links.
Associated Links:

Genetic Testing Consent Form, NGS Genetic Testing Consent Form



Collection Instructions

Specimen:Tissue
Optimal Volume:Fixed tissue: 6 unstained slides (10 microns thick) and 1 H&E slide (10 microns thick) fixed tissue.
Collection Instructions:The measured tumor size and lymph node status of the patient must be I indicated with the order to ensure accurate results.
Causes for Rejection:Fresh tissue, frozen tissue, embedded tissue not formalin fixed, non-breast tumors. Patient does not meet the specific criteria for testing. DNA extracted at non-CLIA certified (or equivalent) lab.


Processing and Shipping

Specimen Processing:Do not process. Store at room temperature.
Shipping Instructions:Ship at room temperature. Do not refrigerate or freeze.
Test Performed at or Referral Lab Molecular Diagnostics  (UMMC-East Bank)


Interpretive

Reference Range:See interpretive report.
Use:The Prosigna Breast Cancer Prognostic Gene Signature Assay is an FDA approved in vitro diagnostic assay that generates a numerical score and risk category for a patient's risk of distant disease recurrence. The test is validated for post-menopausal patients with hormone receptor positive breast cancer and positive lymph nodes.


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