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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Genomic Prostate Score (GPS)
Test CodeCPT Codes
0047U<br>Limited Access Code
Preferred Specimen
Minimum Volume
Other Acceptable Specimens
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
Slides: Room temperature
Specimen Stability
Room temperature: Unacceptable
Refrigerated: Overnight
Frozen: Unacceptable
Slides
Room temperature: Overnight
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Real-Time PCR
Setup Schedule
Reference Range
Clinical Significance