Skip Ribbon Commands
Skip to main content
Sign In
Navigate Up

23408 Oncotype Dx Breast Cancer Assay

Oncotype Dx Breast Cancer Assay
Test Code: ONCDXSO
Synonyms/Keywords
Oncotype DX Breast Cancer Assay
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.​
Useful For
  • Identify those patients who will derive benefit from chemotherapy
  • Determine the magnitude of chemotherapy benefit
  • Make chemotherapy a personalized treatment
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.

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
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Genomic Health​ Monday through Friday​ ​7-10 days ​IHC, DNA extraction
Reference Lab
Genomic Health
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​
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81519 ​ ​1 ​
Synonyms/Keywords
Oncotype DX Breast Cancer Assay
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.​
Ordering Applications
Ordering Application Description
​Centricity ​Oncotype Dx
​Cerner ​Oncotype DX
COM​ ​Oncotype Dx Breast Cancer
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
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.

Collection Processing

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
Useful For
  • Identify those patients who will derive benefit from chemotherapy
  • Determine the magnitude of chemotherapy benefit
  • Make chemotherapy a personalized treatment
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.​
Reference Range Information
Performing Location Reference Range
Genomic Health​ Interpretive Report​
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Genomic Health​ Monday through Friday​ ​7-10 days ​IHC, DNA extraction
Reference Lab
Genomic Health
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81519 ​ ​1 ​
For most current information refer to the Marshfield Laboratory online reference manual.