Decipher Prostate

Test Code
18711


CPT Codes
81542<br>Restricted Client Code

Preferred Specimen
Formalin-fixed paraffin-embedded (FFPE) tissue block with the highest-Grade Group (Gleason score) collected in small zip-lock bag, or
Formalin-fixed paraffin-embedded (FFPE) block of diagnostic needle core biopsy collected in
small zip-lock bag, or
6 slides of thick serially sectioned unstained slides collected in slide holders, or
10 slides of thick serially sectioned unstained slides collected in slide holders


Instructions

OPTION 1: BLOCK SUBMISSION
For Radical Prostatectomy:
Select one (1) formalin fixed paraffin embedded (FFPE) tissue block with the highest Grade Group (Gleason score) and at least 0.5 cm(2) of tumor tissue by area.

For Biopsy:
Select one (1) formalin fixed paraffin embedded (FFPE) block of diagnostic needle core biopsy with at least 0.5 mm in total linear length of tumor tissue with the highest Grade Group (Gleason score) of tumor

OPTION 1: BLOCK
1. Place the selected FFPE block into the small zip-lock bag.
2. Place the small zip-lock bag containing the block into the foam insert.

OPTION 2: SLIDES
For Radical Prostatectomy:
Submit six (6) 5 microns thick serially sectioned unstained slides. Label the serial sectioned slides (1-6) in the order in which they were cut. Air dry slides overnight or until no water is visible under the paraffin section and store unstained slides at 4° C until shipping.

For Biopsy:
Submit ten (10) 5 microns thick serially sectioned unstained slides. Label the serial sectioned slides (1-10) in the order in which they were cut. Air dry slides overnight or until no water is visible under the paraffin section and store unstained slides at 4° C until shipping.

OPTION 2: SLIDES
1. Place slides into the two (2) slide holders (up to 5 slides each).
2. Place the slide holder(s) back into the foam insert in the specimen kit.
3. Fold Test Requisition, Pathology Report and place all paperwork into the specimen kit, between the dividing flap and the foam insert.
4. Fold down the dividing flap, place the provided cold pack on top of the flap and close the specimen kit.
5. Place the closed specimen kit into the FedEx® Clinical Lab Pak and apply the shipping label provided.
6. Ship via your regular scheduled FedEx® pickup or call Customer Support at 1.888.792.1601 to schedule a pick up.

Note: Though both charged and uncharged slides are accepted, charged slides are preferred



Transport Temperature
Room temperature


Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable


Methodology
Microarray

Setup Schedule
Set up: Mon-Sat; Report available: 7-10 days from receipt


Reference Range
See Laboratory Report


Clinical Significance
Decipher Prostate RP is intended for use in patients with localized prostate cancer after radical prostatectomy (RP) with undetectable, persistent, or rising prostate-specific antigen (PSA) who are being considered for treatment and have not received pelvic radiation or hormone therapy prior to RP. Decipher results are intended for use as an adjunct to conventional clinical risk factors for determining the metastatic potential of the tumor and patient prognosis.




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.