Genomic Prostate Score (GPS)

Test Code
39116


CPT Codes
0047U<br>Limited Access Code

Preferred Specimen
Fixed paraffin-embedded (FPE) tissue block


Minimum Volume
1 mm or 5% tumor involvement


Other Acceptable Specimens
⁠⁠⁠⁠⁠⁠⁠8 (5 micron) serial unstained slides with 1 (5 micron) serial section on each slide


Instructions

Neutral buffered formalin is the preferred fixative. Alternative fixatives are not recommended.

BLOCKS:
1. Follow your laboratory?s standard practice guidelines for the processing of fixed paraffin embedded (FPE) tissue
2. Apply one S barcode label, obtained from the inner top lid of the Oncotype DX® Specimen Kit, to each block
3. Place the tumor block in the small plastic bag and seal the bag.
4. Do not submit an H&E slide when you are submitting tumor blocks. Genomic Health® will prepare an H&E slide on site.
5. Secure the specimen in the foam insert inside the Oncotype DX Specimen Kit.
6. Include a frozen ice pack (provided with the Oncotype DX Specimen Kit) on top of the foam insert and seal the secondary containment bag.
NOTE: The ice pack included with the kit should be frozen overnight for best use.

UNSTAINED SLIDES:
NOTE: Follow your laboratory?s standard practice guidelines for the processing of FPE tissue.
To reduce cross-contamination:
- Use a new section of the microtome blade (or a new blade) between cases.
- Clean the water bath between cases (e.g., using a clean Kimwipe).
- Wear clean gloves during the cutting and mounting process.
1. Prepare eight 5 um serial unstained slides with one 5 um serial section on
each slide.
A.) Use charged glass slides (standard 1? x 3? or 25mm x 75mm size).
B.) Ensure the sections on each slide are oriented similarly.
C.) Allow the slides to air dry. Do not place the slides on a hot plate.
D.) Do not place cover slips on the unstained slides.

2. Label the slides as follows:
A.) Apply one S barcode label, obtained from the inner top lid of the Oncotype DX Specimen Kit, to each slide



Transport Temperature
Formalin paraffin-embedded tissue: Refrigerated (cold packs)
Slides: Room temperature


Specimen Stability
Formalin paraffin-embedded tissue
Room temperature: Unacceptable
Refrigerated: Overnight
Frozen: Unacceptable

Slides
Room temperature: Overnight
Refrigerated: Unacceptable
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
For prostate submissions, radical prostatectomy specimens are not accepted. Genomic uses CLIA system for auto reject


Methodology
Real-Time PCR

Setup Schedule
Set up: Daily; Report available: 11-15 days from receipt of specimen


Reference Range
See Laboratory Report


Clinical Significance
The Oncotype DX Genomic Prostate Score (GPS) assay is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The assay analyzes prostate cancer gene activity to predict disease aggressiveness.




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.