Prosigna™Breast Cancer Prognostic Gene Signature Assay
Methodology
Molecular
Test Description and clinical significance
Disease:
breast cancer
The Prosigna® Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is
performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously
diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted
together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of
distant recurrence of disease.
Specimen Requirements
Collection:
Formalin-fixed, paraffin-embedded (FFPE) (only 10 micron thickness) hormone-receptor positive breast tumor tissue
specimen that is further specified by a pathologist as one of the following types of invasive
breast carcinoma: a. Invasive ductal carcinoma
b. Invasive lobular carcinoma
c. Invasive carcinoma with ductal and lobular features (“mixed type carcinoma”)
d. No special type (NST) or not otherwise specified (NOS)
The test requires unstained slide mounted tissue sections for processing and a corresponding
H&E stained slide from the FFPE tumor block
Stability:
Room temperature
Unacceptable Conditions:
If the tissue review process shows that the tumor block has insufficient tumor area or insufficient
tumor cellularity. If there are no FFPE blocks which contain sufficient tumor tissue, then the Prosigna Assay should not be run.
Storage & Transport
All samples must be labeled with the patient’s name, case number and specimen type.
The specimen must be accompanied by the appropriate laboratory requisition containing
the following information: patient’s name, date of birth, medical record number, sample
type, test requested and the name of the ordering physician. Alternatively, this information
is available from the laboratory information system.
> Samples may be shipped at room temperature. If exposure to elevated temperatures during shipment
is a concern, cold packs may be added.
CPT(s)
81520, 88381 & G0452(26)
New York Approved
YES
TAT
7-10 days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
