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Oncotype DX Breast Recurrence
Test Code39888
CPT Codes
81519<br>Restricted Client Code
Preferred Specimen
Formalin-fixed, paraffin-embedded (FPE) tissue submitted in Oncotype DX Specimen Kit
Other Acceptable Specimens
15 serial unstained (5 micron sections) slides with 1 (5 micron sections) serial section on each slide
Instructions
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 (see photo).
3. Label the block with an additional patient-specific identifier (e.g., specimen accession number, patient medical record number, etc.). All specimens require two patient-specific identifiers for processing.
4. Place the tumor block in the small plastic bag and seal the bag.
5. Do not submit an H&E slide when you are submitting tumor blocks. Genomic Health will prepare an H&E slide on site.
6. Secure the specimen in the foam insert inside the Oncotype DX Specimen Kit.
7. Include a frozen ice pack (provided with the Oncotype DX Specimen Kit) on top of the foam insert and seal the secondary containment bag. The ice pack included with the kit should be frozen overnight for best use.
Unstained Slides:
1. Prepare fifteen 5 serial unstained slides with one 5 serial section on each slide.
A. Use charged glass slides (standard 1 x 3 or 25 mm x 75 mm 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 (see photo).
B. Label the slides with an additional patient-specific identifier (e.g., specimen accession number, patient name, date of birth, hospital number, or order number). All specimens require two patient-specific identifiers for processing.
C. Hand-number the serially sectioned unstained slides (1-15) to indicate the order in which they were cut.
3. Once the slides are dry, insert them into slide carriers. Place the slide carriers in the Oncotype DX Specimen Kit for shipping.
4. Seal the large secondary containment bag.
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 (see photo).
3. Label the block with an additional patient-specific identifier (e.g., specimen accession number, patient medical record number, etc.). All specimens require two patient-specific identifiers for processing.
4. Place the tumor block in the small plastic bag and seal the bag.
5. Do not submit an H&E slide when you are submitting tumor blocks. Genomic Health will prepare an H&E slide on site.
6. Secure the specimen in the foam insert inside the Oncotype DX Specimen Kit.
7. Include a frozen ice pack (provided with the Oncotype DX Specimen Kit) on top of the foam insert and seal the secondary containment bag. The ice pack included with the kit should be frozen overnight for best use.
Unstained Slides:
1. Prepare fifteen 5 serial unstained slides with one 5 serial section on each slide.
A. Use charged glass slides (standard 1 x 3 or 25 mm x 75 mm 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 (see photo).
B. Label the slides with an additional patient-specific identifier (e.g., specimen accession number, patient name, date of birth, hospital number, or order number). All specimens require two patient-specific identifiers for processing.
C. Hand-number the serially sectioned unstained slides (1-15) to indicate the order in which they were cut.
3. Once the slides are dry, insert them into slide carriers. Place the slide carriers in the Oncotype DX Specimen Kit for shipping.
4. Seal the large secondary containment bag.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Overnight
Refrigerated: Unacceptable
Frozen: Unacceptable
Refrigerated: Unacceptable
Frozen: Unacceptable
Methodology
Real-Time PCR
Setup Schedule
Set up: Daily; Report available: 11-15 days from receipt of specimen
Reference Range
See Laboratory Report
