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HelpTest Code ONCDXSO Oncotype Dx Breast Cancer Assay
Useful For
Identify those patients who will derive benefit from chemotherapy. Determine the magnitude of chemotherapy benefit. Make chemotherapy a personalized treatment.
Synonyms/Keywords
Oncotype DX Breast Cancer Assay
Specimen Requirements
| Specimen Type | Preferred Container/Tube | Acceptable Container/Tube | Specimen Volume | Specimen Minimum Volume (allows for 1 repeat) |
Pediatric Minimum Volume (no repeat) |
|---|---|---|---|---|---|
| Tissue | FFPE block (use special collection kit) | Slides (use special collection kit) | 15 serial unstained slides with one 5 micron section on each slide. | * see below | |
|
Use charged glass slides, ensure the sections on each slide are oriented similarily, allow slides to air dry and do not place cover slips on the unstained slides. *Minimum Requirements: For FFPE block, choose block with the greatest amount/area of the highest grade carcinoma, morphologically consistent with the submitting diagnosis and the least amount of non-invasive mammary epithelium. |
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Collection/Processing Instructions
Oncotype DX Specimen Collection and Transportation Kit is available in Lab Specimen Processing (715-221-6220). Request form must be completed by physician and accompany sample. All samples must be labeled with the "S" barcode labels from that patient's specific kit.
**SPECIAL INSTRUCTIONS**
Instructions for Outreach Sendout Testing (AP only):
1. Outreach Client contacts Genomic Health directly.
2. Client sets up account (if not existing previously) with Genomic Health and provides necessary information, including location of specimen/block.
3. Genomic Health will provide instructions on how to proceed.
4. If additional information is needed, please contact your Marshfield Labs Account Executive or Account Service Representative.
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Paraffin-embedded tissue or unstained slides | Ambient | Indefinite |
Test Components
The Oncotype DX assay is a 21-gene assay that provides an individualized prediction of chemotherapy benefit and 10-year distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer.
Test Information
Hemorrhage, necrosis, and adipose tissue do not need to be minimized as they do not significantly impact this assay. Total mastectomy specimens are not appropriate samples.
Reference Range Information
| Performing Location | Reference Range |
|---|---|
| Genomic Health | Interpretive Report |
Performing Laboratory Name
Genomic Health
Referral Laboratory Information
| Address | Telephone | Website Link | Marshfield Lab Account # |
|---|---|---|---|
|
501 Galveston Drive Redwood City, CA 94063-4700 |
866-662-6897 | https://www.oncotypeiq.com | A002AVE |
Performing Information
| Performing Location | Day(s) Test Performed | Analytical Time | Methodology/Instrumentation |
|---|---|---|---|
| Genomic Health | Monday through Friday | 7-10 days | IHC, DNA extraction |
CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 81519 | 1 |
Outreach CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 81519 | 1 |
Ordering Applications
| Ordering Application | Description |
|---|---|
| Centricity | Oncotype Dx |
| Cerner | Oncotype DX |
| COM | Oncotype Dx Breast Cancer |